Psychological Intervention to Reduce Weight Bias Internalization

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT03572218
Collaborator
Weight Watchers International (Industry)
72
1
2
18.3
3.9

Study Details

Study Description

Brief Summary

This is a randomized controlled trial to test the effects on WBI of a novel psychological intervention combined with standard behavioral weight loss (BWL) treatment, as compared to BWL alone. Participants will be a total of 72 men and women seeking weight loss, ages 18-65 years, with a body mass index (BMI) of 30 kg/m2 or above, a history of experiencing weight bias, and elevated levels of WBI. Participants will attend a screening visit in which they will complete a behavioral evaluation with a psychologist and a medical history that will be reviewed by a nurse practitioner or physician. Questionnaires assessing experiences and internalization of weight bias, with confirmation by interviewer assessment during the behavioral evaluation, will be used to determine whether participants meet criteria for having high levels of WBI. Eligible consenting participants will be randomly assigned to the standard BWL intervention (n = 36) or the BWL + BIAS program (n = 36). All participants will attend weekly, 90-minute group meetings for 12 weeks (12 visits). In the BWL + stigma intervention, 60 minutes will be devoted to BWL and 30 minutes to weight stigma. In the standard BWL treatment group, the additional 30 minutes will be devoted to sharing recipes and food preparation tips. Following 12 weeks of weight loss treatment, participants will attend group meetings focused on weight loss maintenance, every-other-week from weeks 13-16 (2 visits), and monthly from weeks 17-26 (2 visits). Maintenance sessions in the BWL + stigma group will continue to incorporate discussion of WBI. Assessments - which include questionnaires and measurements of body weight - will occur at baseline and weeks 12 and 26. Weight will be measured at every group meeting for clinical purposes.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: BWL
  • Behavioral: BIAS
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Trial of a Psychological Intervention to Reduce Weight Bias Internalization in the Context of Behavioral Weight Loss
Actual Study Start Date :
Apr 10, 2018
Actual Primary Completion Date :
Apr 9, 2019
Actual Study Completion Date :
Oct 18, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: BWL + BIAS

The behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group will include standard BWL treatment (described in more detail in Intervention section) combined with a weight stigma-reduction intervention. During the initial 12 weeks, the weekly 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the every-other-week and monthly weight loss maintenance sessions from weeks 13-26, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically in the context of weight management.

Behavioral: BWL
The BWL sessions will be based on the Diabetes Prevention Program (DPP) manual. A diet of 1200-1499 calories per day will be prescribed for participants < 250 lb, and 1500-1800 for those ≥ 250 lb. Participants will be instructed to eat a balanced deficit diet. Session topics during the first 12 weeks will include self-monitoring, stimulus control, slowing eating, social support, cognitive restructuring, portion sizes, and goal-setting. Those during weeks 13-26 will focus on continued self-monitoring and skills required for weight loss maintenance and relapse prevention. Physical activity will be prescribed at a level consistent with data showing that >250 min/wk is associated with improved long-term weight loss. BWL sessions will last 60 minutes.

Behavioral: BIAS
Following 60 minutes of BWL treatment, the BIAS intervention will devote 30 minutes to stigma-related content. Session topics will include: psychoeducation about weight and weight stigma; challenging myths and cognitive distortions related to weight; strategies for coping with instances of stigma; and increasing empowerment and body esteem. The effects of weight stigma on health behaviors will be discussed, and sessions will focus specifically on helping participants overcome stigma-related barriers to weight management. In the every-other-week and monthly weight loss maintenance sessions from weeks 13-26, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies in the context of weight management.

Active Comparator: Standard BWL

The Standard BWL group will receive weekly BWL sessions (described in more detail in Intervention section) for 12 weeks, followed by every-other-week and monthly weight loss maintenance sessions from weeks 13-26. BWL content will last for 60 minutes, with an additional 30 minutes in this group devoted to discussing recipes and food preparation.

Behavioral: BWL
The BWL sessions will be based on the Diabetes Prevention Program (DPP) manual. A diet of 1200-1499 calories per day will be prescribed for participants < 250 lb, and 1500-1800 for those ≥ 250 lb. Participants will be instructed to eat a balanced deficit diet. Session topics during the first 12 weeks will include self-monitoring, stimulus control, slowing eating, social support, cognitive restructuring, portion sizes, and goal-setting. Those during weeks 13-26 will focus on continued self-monitoring and skills required for weight loss maintenance and relapse prevention. Physical activity will be prescribed at a level consistent with data showing that >250 min/wk is associated with improved long-term weight loss. BWL sessions will last 60 minutes.

Outcome Measures

Primary Outcome Measures

  1. Weight Bias Internalization [Baseline to week 12]

    Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)

Secondary Outcome Measures

  1. Weight Bias Internalization [Baseline to week 26]

    Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)

  2. Weight Self-Stigma Questionnaire (WSSQ) [Baseline to week 12]

    Estimated mean change score for Total score (WSSQ-Total, summed 12-60) and two subscales of Self-Devaluation (WSSQ-SD) and Fear of Enacted Stigma (WSSQ-FNE) (summed 6-30); higher scores indicate greater weight self-stigma

  3. Weight Self-Stigma Questionnaire (WSSQ) [Baseline to week 26]

    Estimated mean change score for Total score (WSSQ-Total, summed 12-60) and two subscales of Self-Devaluation (WSSQ-SD) and Fear of Enacted Stigma (WSSQ-FNE) (summed 6-30); higher scores indicate greater weight self-stigma

  4. Weight Bias [Baseline to week 12]

    Estimated mean change score on the Fat Phobia Scale (scale scoring 1-5; higher scores indicate greater weight bias)

  5. Weight Bias [Baseline to week 26]

    Estimated mean change score on the Fat Phobia Scale (scale scoring 1-5; higher scores indicate greater weight bias)

  6. Weight-Related Quality of Life [Baseline to week 12]

    Estimated mean change score on the Impact of Weight on Quality of Life Questionnaire-Lite for Total score and five subscales of Physical Function, Self Esteem, Sexual Life, Work, and Public Distress (transformed scores 0-100; higher scores indicate better quality of life)

  7. Weight-Related Quality of Life [Baseline to week 26]

    Estimated mean change score on the Impact of Weight on Quality of Life Questionnaire-Lite for Total score and five subscales of Physical Function, Self Esteem, Sexual Life, Work, and Public Distress (transformed scores 0-100; higher scores indicate better quality of life)

  8. Perceived Stress [Baseline to week 12]

    Estimated mean change score on the Perceived Stress Scale (summed 0-40; higher scores indicate greater perceived stress)

  9. Perceived Stress [Baseline to week 26]

    Estimated mean change score on the Perceived Stress Scale (summed 0-40; higher scores indicate greater perceived stress)

  10. Depression [Baseline to week 12]

    Estimated mean change score on the Patient Health Questionnaire - 9 (summed 0-27; higher scores indicate more symptoms of depression)

  11. Depression [Baseline to week 26]

    Estimated mean change score on the Patient Health Questionnaire - 9 (summed 0-27; higher scores indicate more symptoms of depression)

  12. Exercise Self-Efficacy [Baseline to week 12]

    Estimated mean change score on the Self-Efficacy for Exercise Scale (summed 0-90; higher scores indicate greater self-efficacy)

  13. Exercise Self-Efficacy [Baseline to week 26]

    Estimated mean change score on the Self-Efficacy for Exercise Scale (summed 0-90; higher scores indicate greater self-efficacy)

  14. Eating Self-Efficacy [Baseline to week 12]

    Estimated mean change score on the Weight and Lifestyle Efficacy - Short Form (summed 0-80; higher scores indicate greater self-efficacy)

  15. Eating Self-Efficacy [Baseline to week 26]

    Estimated mean change score on the Weight and Lifestyle Efficacy - Short Form (summed 0-80; higher scores indicate greater self-efficacy)

  16. Percent Weight Change [Baseline to week 26]

    Estimated mean change in percent weight change. Weight measured in kilograms (kg).

  17. Waist Circumference [Baseline to week 26]

    Estimated mean change in waist circumference (cm).

  18. Blood Pressure [Baseline to week 26]

    Estimated mean change in blood pressure (systolic blood pressure and diastolic blood pressure; mmHg), controlling for blood pressure medication.

Other Outcome Measures

  1. Coping Behaviors in Response to Weight Stigma [Baseline to week 12]

    Estimated mean change score on the Coping with Weight Stigma Questionnaire for Full scale and four subscales of Negative Affect, Maladaptive Eating, Healthy Lifestyle, and Exercise Avoidance (scale scoring 0-4 for Full scale and all subscales); higher scores indicate greater endorsement of coping strategies

  2. Coping Behaviors in Response to Weight Stigma [Baseline to week 26]

    Estimated mean change score on the Coping with Weight Stigma Questionnaire for Full scale and four subscales of Negative Affect, Maladaptive Eating, Healthy Lifestyle, and Exercise Avoidance (scale scoring 0-4 for Full scale and all subscales); higher scores indicate greater endorsement of coping strategies

  3. Body Esteem [Baseline to Week 12]

    Estimated mean change score on the Body Appreciation Scale (scale scoring 1-5; higher scores indicate greater body appreciation)

  4. Body Esteem [Baseline to Week 26]

    Estimated mean change score on the Body Appreciation Scale (scale scoring 1-5; higher scores indicate greater body appreciation)

  5. Body Dissatisfaction [Baseline to Week 12]

    Estimated mean change score on the Body Areas Satisfaction Subscale of the Multidimensional Body-Self Relations Questionnaire-Appearance Scales (scale scoring 1-5; higher scores indicating greater satisfaction)

  6. Body Dissatisfaction [Baseline to Week 26]

    Estimated mean change score on the Body Areas Satisfaction Subscale of the Multidimensional Body-Self Relations Questionnaire-Appearance Scales (scale scoring 1-5; higher scores indicating greater satisfaction)

  7. Disordered Eating [Baseline to Week 12]

    Estimated mean change score on the Eating Disorders Examination Questionnaire for Global score and four subscales of Eating Restraint, Eating Concern, Weight Concern, and Shape Concern (scale scoring 0-6 for Global score and all subscales; higher scores indicate greater pathology)

  8. Disordered Eating [Baseline to Week 26]

    Estimated mean change score on the Eating Disorders Examination Questionnaire for Global score and four subscales of Eating Restraint, Eating Concern, Weight Concern, and Shape Concern (scale scoring 0-6 for Global score and all subscales; higher scores indicate greater pathology)

  9. Eating Behaviors [Baseline to Week 12]

    Estimated mean change score on the Eating Inventory Questionnaire for three subscales of Dietary Restraint (summed 0-21), Disinhibition (summed 0-16), and Hunger (summed 0-14); higher values indicate greater restraint/disinhibition/hunger

  10. Eating Behaviors [Baseline to Week 26]

    Estimated mean change score on the Eating Inventory Questionnaire for three subscales of Dietary Restraint (summed 0-21), Disinhibition (summed 0-16), and Hunger (summed 0-14); higher values indicate greater restraint/disinhibition/hunger

  11. Anxiety [Baseline to Week 12]

    Estimated mean change score on the Generalized Anxiety Disorder-7 Questionnaire (summed 0-21; higher scores indicate greater anxiety)

  12. Anxiety [Baseline to Week 26]

    Estimated mean change score on the Generalized Anxiety Disorder-7 Questionnaire (summed 0-21; higher scores indicate greater anxiety)

  13. Dietary Monitoring [Baseline to Week 12]

    Estimated mean change in number of days recording caloric intake

  14. Dietary Monitoring [Baseline to Week 26]

    Estimated mean change in number of days recording caloric intake

  15. Self-Reported Self-Monitoring Behaviors [Baseline to Week 12]

    Estimated mean change in self-reported frequency of tracking of: weight, food/drink, calories, and physical activity; 0-4 rating for each of the four behaviors (higher scores indicate greater self-reported frequency of self-monitoring behavior)

  16. Self-Reported Self-Monitoring Behaviors [Baseline to Week 26]

    Estimated mean change in self-reported frequency of tracking of: weight, food/drink, calories, and physical activity; 0-4 rating for each of the four behaviors (higher scores indicate greater self-reported frequency of self-monitoring behavior)

  17. Weight Bias Internalization [Baseline to week 52]

    Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)

  18. Weight Self-Stigma Questionnaire (WSSQ) [Baseline to week 52]

    Estimated mean change score for Total score (WSSQ-Total, summed 12-60) and two subscales of Self-Devaluation (WSSQ-SD) and Fear of Enacted Stigma (WSSQ-FNE) (summed 6-30); higher scores indicate greater weight self-stigma

  19. Weight Bias [Baseline to week 52]

    Estimated mean change score on the Fat Phobia Scale (scale scoring 1-5; higher scores indicate greater weight bias)

  20. Depression [Baseline to week 52]

    Estimated mean change score on the Patient Health Questionnaire - 9 (summed 0-27; higher scores indicate more symptoms of depression)

  21. Perceived Stress [Baseline to week 52]

    Estimated mean change score on the Perceived Stress Scale (summed 0-40; higher scores indicate greater perceived stress)

  22. Exercise Self-Efficacy [Baseline to week 52]

    Estimated mean change score on the Self-Efficacy for Exercise Scale (summed 0-90; higher scores indicate greater self-efficacy)

  23. Weight-Related Quality of Life [Baseline to week 52]

    Estimated mean change score on the Impact of Weight on Quality of Life Questionnaire-Lite for Total score and five subscales of Physical Function, Self Esteem, Sexual Life, Work, and Public Distress (transformed scores 0-100; higher scores indicate better quality of life)

  24. Eating Self-Efficacy [Baseline to week 52]

    Estimated mean change score on the Weight and Lifestyle Efficacy - Short Form (summed 0-80; higher scores indicate greater self-efficacy)

  25. Percent Weight Change [Baseline to week 52]

    Estimated mean change in percent weight change. Weight measured in kilograms (kg)

  26. Waist Circumference [Baseline to week 52]

    Estimated mean change in waist circumference (cm)

  27. Blood Pressure [Baseline to week 52]

    Estimated mean change in blood pressure (systolic blood pressure and diastolic blood pressure; mmHg), controlling for blood pressure medication.

  28. Body Esteem [Baseline to Week 52]

    Estimated mean change score on the Body Appreciation Scale (scale scoring 1-5; higher scores indicate greater body appreciation)

  29. Coping Behaviors in Response to Weight Stigma [Baseline to Week 52]

    Estimated mean change score on the Coping with Weight Stigma Questionnaire for Full scale and four subscales of Negative Affect, Maladaptive Eating, Healthy Lifestyle, and Exercise Avoidance (scale scoring 0-4 for Full scale and all subscales); higher scores indicate greater endorsement of coping strategies

  30. Body Dissatisfaction [Baseline to Week 52]

    Estimated mean change score on the Body Areas Satisfaction Subscale of the Multidimensional Body-Self Relations Questionnaire-Appearance Scales (scale scoring 1-5; higher scores indicating greater satisfaction)

  31. Anxiety [Baseline to Week 52]

    Estimated mean change score on the Generalized Anxiety Disorder-7 Questionnaire (summed 0-21; higher scores indicate greater anxiety)

  32. Disordered Eating [Baseline to Week 52]

    Estimated mean change score on the Eating Disorders Examination Questionnaire for Global score and four subscales of Eating Restraint, Eating Concern, Weight Concern, and Shape Concern (scale scoring 0-6 for Global score and all subscales; higher scores indicate greater pathology)

  33. Eating Behaviors [Baseline to Week 52]

    Estimated mean change score on the Eating Inventory Questionnaire for three subscales of Dietary Restraint (summed 0-21), Disinhibition (summed 0-16), and Hunger (summed 0-14); higher values indicate greater restraint/disinhibition/hunger

  34. Self-Reported Self-Monitoring Behaviors [Baseline to Week 52]

    Estimated mean change in self-reported frequency of tracking of: weight, food/drink, calories, and physical activity; 0-4 rating for each of the four behaviors (higher scores indicate greater self-reported frequency of self-monitoring behavior)

  35. Treatment Acceptability Ratings [Week 26]

    To assess treatment acceptability, participants in both groups rated (1-7) the BWL treatment, as well as the stigma intervention (i.e., BIAS component) or recipe exchange, on how helpful they found each component of the program, how much they liked the components, and how much they learned new skills or information from each component. Scores for these three items were averaged (1-7) separately for the BWL treatment, BIAS component, and recipe exchange. Higher scores indicate greater treatment acceptability.

  36. Treatment Acceptability Ratings [Week 52]

    To assess treatment acceptability, participants rated (1-7) 5 items to indicate the extent to which they found the program (as a whole) to be helpful and acceptable, and how much they liked, were satisfied with, and would recommend the program to others. Scores are averaged 1-7, with higher scores indicating greater treatment acceptability.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Eligible participants will be men and women ages 18-65 years.

  • Participants must have obesity (defined as a BMI ≥ 30 kg/m2); report a history of experiencing weight bias as assessed by self-report questionnaire and in-person interview; and have elevated levels of WBI as indicated by an average score of 4 (midpoint) or above on the Weight Bias Internalization Scale (WBIS) and by in-person interview.

  • Participants must be seeking weight loss.

  • If currently taking medications, dosages must be stable for at least 3 months.

  • Participants will be eligible to participate if they exhibit mild to moderate severity of depression, anxiety, or binge eating disorder, as determined by the behavioral evaluation and the screening measures (Beck Depression Inventory-II and Questionnaire for Eating and Weight Patterns; see below for details). Elevated WBIS scores are often associated with these variables.

  • Participants taking anti-depressant medication will be eligible if their dose has been stable for a minimum of 3 months.

Eligible female patients will be:
  • non-pregnant, evidenced by a negative urine dipstick pregnancy test

  • non-lactating

  • surgically sterile or postmenopausal, or they will agree to continue to use a method of birth control during the study

Participants must:
  • have a PCP who is responsible for providing routine care

  • have reliable telephone service with which to participate in conference calls

  • understand and be willing to comply with all study-related procedures and agree to participate in the study by giving written informed consent

Exclusion Criteria:
Applicants will be excluded if they have:
  • a diagnosis of type I or II diabetes;

  • uncontrolled hypertension (blood pressure ≥ 160/100 mm Hg);

  • experienced a cardiovascular event (e.g., stroke, myocardial infarction) in the last 12 months;

  • lost ≥ 5% of their initial weight in the last 6 months;

  • or have participated in individual or group psychotherapy in the last 3 months (due to the potentially confounding effects of receiving a simultaneous cognitive-behavioral intervention). Applicants who have recently participated in or are currently receiving counseling for concerns unrelated to mood, self-esteem, or weight (e.g. career, marriage, or grief counseling; caregiver support) may be eligible per Principal Investigator's discretion.

  • Applicants with severe symptoms of mood (for example, BDI-II score ≥ 29), anxiety, or binge eating disorder, and any severity of thought or substance use disorders will not be accepted into the study, as these symptoms may interfere with individuals' ability to adhere to a weight loss program. Clinician judgment will be used to determine severity of mood disorder symptoms independent from obesity-related concerns and complications (e.g., fatigue), and decisions about applicants' eligibility based on psychiatric symptoms will fall within the Principal Investigator's discretion.

  • Individuals with bulimia nervosa will not be eligible to participate, because weight loss may be contraindicated.

  • Applicants with current, active suicidal ideation, and/or a suicide attempt within the past year will be excluded from the study and referred to psychiatric treatment facilities in the greater Philadelphia area.

  • Applicants will not be eligible if they have a history of bariatric surgery.

  • Women who are nursing, pregnant, or planning to become pregnant in the next 12 months are not eligible to participate.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Pennsylvania Center for Weight and Eating Disorders Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • University of Pennsylvania
  • Weight Watchers International

Investigators

  • Principal Investigator: Rebecca L Pearl, PhD, University of Pennsylvania

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Rebecca L. Pearl, Ph.D., Assistant Professor, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT03572218
Other Study ID Numbers:
  • 829070
First Posted:
Jun 28, 2018
Last Update Posted:
Oct 23, 2020
Last Verified:
Sep 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details Recruitment began April 2018 and ended October 2018. Participants were recruited by flyers, local media, and physician referrals for a study about weight loss and social experiences related to weight. Participants were screened by telephone and by a subsequent in-person behavioral evaluation and brief medical evaluation.
Pre-assignment Detail
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Period Title: Overall Study
STARTED 36 36
Week 12 30 31
Week 26 30 31
COMPLETED 30 31
NOT COMPLETED 6 5

Baseline Characteristics

Arm/Group Title BWL + BIAS Standard BWL Total
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. Total of all reporting groups
Overall Participants 36 36 72
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
47.7
(11.4)
46.6
(11.8)
47.1
(11.5)
Sex: Female, Male (Count of Participants)
Female
32
88.9%
29
80.6%
61
84.7%
Male
4
11.1%
7
19.4%
11
15.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
4
11.1%
2
5.6%
6
8.3%
Not Hispanic or Latino
32
88.9%
34
94.4%
66
91.7%
Unknown or Not Reported
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
2
5.6%
0
0%
2
2.8%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
26
72.2%
22
61.1%
48
66.7%
White
7
19.4%
14
38.9%
21
29.2%
More than one race
1
2.8%
0
0%
1
1.4%
Unknown or Not Reported
0
0%
0
0%
0
0%
Weight (kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms]
112.4
(24.0)
107.2
(21.2)
109.8
(22.6)
Height (centimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeters]
167.0
(8.7)
166.6
(8.5)
166.8
(8.5)
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]
40.1
(6.5)
38.4
(5.6)
39.3
(6.1)
Waist Circumference (centimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeters]
119.1
(15.3)
114.9
(12.6)
117.0
(14.1)
Blood Pressure (mmHg) [Mean (Standard Deviation) ]
Systolic Blood Pressure
127.4
(10.2)
128.0
(10.7)
127.7
(10.3)
Diastolic Blood Pressure
73.0
(9.2)
74.3
(7.9)
73.7
(8.5)
Weight Bias Internalization (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]
5.0
(0.7)
5.2
(0.7)
5.1
(0.7)
Weight Self-Stigma Questionnaire (WSSQ) (scores on a scale) [Mean (Standard Deviation) ]
WSSQ-Total
37.9
(6.6)
39.3
(6.9)
38.6
(6.7)
WSSQ-SD
19.1
(4.2)
19.2
(3.9)
19.2
(4.1)
WSSQ-FNE
18.8
(4.6)
20.1
(4.8)
19.4
(4.7)
Weight Bias (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]
3.7
(0.7)
3.7
(0.6)
3.7
(0.6)
Depression (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]
7.5
(5.1)
8.4
(4.5)
8.0
(4.8)
Anxiety (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]
5.6
(4.5)
5.2
(4.2)
5.4
(4.3)
Perceived Stress (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]
17.6
(6.2)
16.9
(6.5)
17.3
(6.4)
Body Esteem (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]
2.8
(0.6)
2.5
(0.7)
2.6
(0.7)
Weight-Related Quality of Life (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]
56.3
(16.7)
54.2
(16.5)
55.3
(16.5)
Eating Self-Efficacy (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]
39.4
(17.4)
40.7
(17.9)
40.0
(17.5)
Exercise Self-Efficacy (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]
48.3
(20.1)
54.2
(19.9)
51.2
(20.0)
Eating Behaviors (scores on a scale) [Mean (Standard Deviation) ]
Dietary Restraint
8.5
(3.7)
8.9
(3.8)
8.7
(3.7)
Disinhibition
9.2
(3.5)
10.2
(3.1)
9.7
(3.3)
Hunger
7.8
(3.6)
6.4
(3.6)
7.1
(3.7)
Self-Reported Self-Monitoring Behaviors (scores on a scale) [Mean (Standard Deviation) ]
Self-Reported Weighing
0.9
(1.2)
0.9
(1.1)
0.9
(1.2)
Track Food/Drink
0.4
(0.7)
0.5
(0.8)
0.5
(0.8)
Track Calories
0.4
(1.0)
0.6
(1.1)
0.5
(1.0)
Track Activity
1.0
(1.5)
1.3
(1.5)
1.2
(1.5)

Outcome Measures

1. Primary Outcome
Title Weight Bias Internalization
Description Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)
Time Frame Baseline to week 12

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [scores on a scale]
-1.3
(0.2)
-1.0
(0.2)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.22
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.3
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.2
Estimation Comments
2. Secondary Outcome
Title Weight Bias Internalization
Description Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)
Time Frame Baseline to week 26

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [scores on a scale]
-1.5
(0.2)
-1.3
(0.2)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.45
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.2
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.3
Estimation Comments
3. Secondary Outcome
Title Weight Self-Stigma Questionnaire (WSSQ)
Description Estimated mean change score for Total score (WSSQ-Total, summed 12-60) and two subscales of Self-Devaluation (WSSQ-SD) and Fear of Enacted Stigma (WSSQ-FNE) (summed 6-30); higher scores indicate greater weight self-stigma
Time Frame Baseline to week 12

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
WSSQ-Total
-6.0
(1.4)
-1.6
(1.3)
WSSQ-SD
-3.6
(0.8)
-1.0
(0.8)
WSSQ-FNE
-2.3
(0.8)
-0.7
(0.8)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments WSSQ-Total
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.03
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.4
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.9
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments WSSQ-SD
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.02
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.8
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.1
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments WSSQ-FNE
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.19
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.6
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.2
Estimation Comments
4. Secondary Outcome
Title Weight Self-Stigma Questionnaire (WSSQ)
Description Estimated mean change score for Total score (WSSQ-Total, summed 12-60) and two subscales of Self-Devaluation (WSSQ-SD) and Fear of Enacted Stigma (WSSQ-FNE) (summed 6-30); higher scores indicate greater weight self-stigma
Time Frame Baseline to week 26

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
WSSQ-Total
-7.1
(1.5)
-3.6
(1.5)
WSSQ-SD
-4.1
(0.8)
-1.5
(0.8)
WSSQ-FNE
-2.9
(0.9)
-2.1
(0.9)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments WSSQ-Total
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.11
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.5
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 2.1
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments WSSQ-SD
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.03
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.6
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.1
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments WSSQ-FNE
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.53
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.8
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.3
Estimation Comments
5. Secondary Outcome
Title Weight Bias
Description Estimated mean change score on the Fat Phobia Scale (scale scoring 1-5; higher scores indicate greater weight bias)
Time Frame Baseline to week 12

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [scores on a scale]
-0.5
(0.1)
-0.2
(0.1)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.12
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.3
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.2
Estimation Comments
6. Secondary Outcome
Title Weight Bias
Description Estimated mean change score on the Fat Phobia Scale (scale scoring 1-5; higher scores indicate greater weight bias)
Time Frame Baseline to week 26

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [scores on a scale]
-0.5
(0.1)
-0.2
(0.1)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.09
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.3
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.2
Estimation Comments
7. Secondary Outcome
Title Weight-Related Quality of Life
Description Estimated mean change score on the Impact of Weight on Quality of Life Questionnaire-Lite for Total score and five subscales of Physical Function, Self Esteem, Sexual Life, Work, and Public Distress (transformed scores 0-100; higher scores indicate better quality of life)
Time Frame Baseline to week 12

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Total
8.3
(2.1)
8.9
(2.0)
Physical Function
9.8
(2.9)
8.8
(2.8)
Self Esteem
12.9
(3.0)
9.2
(3.0)
Sexual Life
5.5
(3.6)
9.5
(3.5)
Work
4.8
(3.1)
6.9
(3.0)
Public Distress
5.7
(2.6)
7.7
(2.6)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Estimated mean change score on the Impact of Weight on Quality of Life Questionnaire-Lite for Total score
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.84
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.6
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 2.9
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Estimated mean change score on the Physical Function Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.82
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.9
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 4.0
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Estimated mean change score on the Self Esteem Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.39
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.7
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 4.3
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Estimated mean change score on the Sexual Life Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.42
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.0
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 5.0
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Estimated mean change score on the Work Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.64
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.0
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 4.3
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Estimated mean change score on the Public Distress Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.59
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.0
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 3.6
Estimation Comments
8. Secondary Outcome
Title Weight-Related Quality of Life
Description Estimated mean change score on the Impact of Weight on Quality of Life Questionnaire-Lite for Total score and five subscales of Physical Function, Self Esteem, Sexual Life, Work, and Public Distress (transformed scores 0-100; higher scores indicate better quality of life)
Time Frame Baseline to week 26

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Total
12.5
(2.1)
14.1
(2.1)
Physical Function
13.7
(2.9)
14.2
(2.8)
Self Esteem
19.1
(3.4)
18.5
(3.3)
Sexual Life
7.0
(3.6)
14.0
(3.5)
Work
8.6
(3.1)
6.8
(3.0)
Public Distress
9.9
(2.6)
11.2
(2.6)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Estimated mean change score on the Impact of Weight on Quality of Life Questionnaire-Lite for Total score
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.58
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.7
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 3.0
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Estimated mean change score on the Physical Function Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.89
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.5
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 4.0
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Estimated mean change score on the Self Esteem Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.90
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.6
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 4.7
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Estimated mean change score on the Sexual Life Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.16
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -7.1
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 5.0
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Estimated mean change score on the Work Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.68
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.8
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 4.3
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Estimated mean change score on the Public Distress Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.72
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.3
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 3.6
Estimation Comments
9. Secondary Outcome
Title Perceived Stress
Description Estimated mean change score on the Perceived Stress Scale (summed 0-40; higher scores indicate greater perceived stress)
Time Frame Baseline to week 12

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [scores on a scale]
-3.2
(1.2)
-0.1
(1.2)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.08
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.0
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.7
Estimation Comments
10. Secondary Outcome
Title Perceived Stress
Description Estimated mean change score on the Perceived Stress Scale (summed 0-40; higher scores indicate greater perceived stress)
Time Frame Baseline to week 26

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [scores on a scale]
-3.9
(1.2)
-1.0
(1.2)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.10
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.9
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.7
Estimation Comments
11. Secondary Outcome
Title Depression
Description Estimated mean change score on the Patient Health Questionnaire - 9 (summed 0-27; higher scores indicate more symptoms of depression)
Time Frame Baseline to week 12

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [scores on a scale]
-3.4
(0.8)
-2.5
(0.8)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.40
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.9
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.1
Estimation Comments
12. Secondary Outcome
Title Depression
Description Estimated mean change score on the Patient Health Questionnaire - 9 (summed 0-27; higher scores indicate more symptoms of depression)
Time Frame Baseline to week 26

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [scores on a scale]
-2.9
(0.8)
-2.9
(0.8)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.98
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.03
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.1
Estimation Comments
13. Secondary Outcome
Title Exercise Self-Efficacy
Description Estimated mean change score on the Self-Efficacy for Exercise Scale (summed 0-90; higher scores indicate greater self-efficacy)
Time Frame Baseline to week 12

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [scores on a scale]
4.0
(4.6)
-5.7
(4.5)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.14
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 9.7
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 6.5
Estimation Comments
14. Secondary Outcome
Title Exercise Self-Efficacy
Description Estimated mean change score on the Self-Efficacy for Exercise Scale (summed 0-90; higher scores indicate greater self-efficacy)
Time Frame Baseline to week 26

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [scores on a scale]
5.8
(4.6)
-6.3
(4.5)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.06
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 12.1
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 6.5
Estimation Comments
15. Secondary Outcome
Title Eating Self-Efficacy
Description Estimated mean change score on the Weight and Lifestyle Efficacy - Short Form (summed 0-80; higher scores indicate greater self-efficacy)
Time Frame Baseline to week 12

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [scores on a scale]
11.3
(3.1)
10.2
(3.1)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.80
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.1
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 4.4
Estimation Comments
16. Secondary Outcome
Title Eating Self-Efficacy
Description Estimated mean change score on the Weight and Lifestyle Efficacy - Short Form (summed 0-80; higher scores indicate greater self-efficacy)
Time Frame Baseline to week 26

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [scores on a scale]
12.0
(3.1)
8.9
(3.1)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.49
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.1
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 4.4
Estimation Comments
17. Secondary Outcome
Title Percent Weight Change
Description Estimated mean change in percent weight change. Weight measured in kilograms (kg).
Time Frame Baseline to week 26

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [percent weight change]
-4.5
(1.0)
-5.9
(1.0)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.31
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.4
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.4
Estimation Comments
18. Secondary Outcome
Title Waist Circumference
Description Estimated mean change in waist circumference (cm).
Time Frame Baseline to week 26

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [change in cm]
-4.3
(0.9)
-5.1
(0.9)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.54
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.8
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.3
Estimation Comments
19. Secondary Outcome
Title Blood Pressure
Description Estimated mean change in blood pressure (systolic blood pressure and diastolic blood pressure; mmHg), controlling for blood pressure medication.
Time Frame Baseline to week 26

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Systolic Blood Pressure
-2.6
(1.6)
-2.4
(1.6)
Diastolic Blood Pressure
-1.5
(1.2)
-2.2
(1.1)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Systolic Blood Pressure
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.94
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.2
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 2.2
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Diastolic Blood Pressure
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.64
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.8
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.6
Estimation Comments
20. Other Pre-specified Outcome
Title Coping Behaviors in Response to Weight Stigma
Description Estimated mean change score on the Coping with Weight Stigma Questionnaire for Full scale and four subscales of Negative Affect, Maladaptive Eating, Healthy Lifestyle, and Exercise Avoidance (scale scoring 0-4 for Full scale and all subscales); higher scores indicate greater endorsement of coping strategies
Time Frame Baseline to week 12

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Full Scale
-0.7
(0.1)
-0.8
(0.1)
Negative Affect
-1.1
(0.1)
-1.2
(0.1)
Maladaptive Eating
-0.7
(0.1)
-0.7
(0.1)
Healthy Lifestyle
0.0
(0.2)
0.1
(0.2)
Exercise Avoidance
-0.8
(0.2)
-0.5
(0.2)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Full Scale
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.58
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.1
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.2
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Negative Affect
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.49
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.1
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.2
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Maladaptive Eating
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.96
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.0
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.1
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Healthy Lifestyle
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.71
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.2
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.3
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Exercise Avoidance
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.41
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.3
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.3
Estimation Comments
21. Other Pre-specified Outcome
Title Coping Behaviors in Response to Weight Stigma
Description Estimated mean change score on the Coping with Weight Stigma Questionnaire for Full scale and four subscales of Negative Affect, Maladaptive Eating, Healthy Lifestyle, and Exercise Avoidance (scale scoring 0-4 for Full scale and all subscales); higher scores indicate greater endorsement of coping strategies
Time Frame Baseline to week 26

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Full Scale
-0.8
(0.1)
-0.9
(0.1)
Negative Affect
-1.3
(0.2)
-1.2
(0.2)
Maladaptive Eating
-0.8
(0.1)
-0.8
(0.1)
Healthy Lifestyle
-0.2
(0.2)
0.0
(0.2)
Exercise Avoidance
-0.9
(0.2)
-0.9
(0.2)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Full Scale
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.61
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.1
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.2
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Negative Affect
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.73
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.1
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.2
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Maladaptive Eating
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.94
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.0
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.1
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Healthy Lifestyle
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.47
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.2
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.3
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Exercise Avoidance
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.99
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.0
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.3
Estimation Comments
22. Other Pre-specified Outcome
Title Body Esteem
Description Estimated mean change score on the Body Appreciation Scale (scale scoring 1-5; higher scores indicate greater body appreciation)
Time Frame Baseline to Week 12

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [scores on a scale]
0.6
(0.1)
0.3
(0.1)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.13
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.3
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.2
Estimation Comments
23. Other Pre-specified Outcome
Title Body Esteem
Description Estimated mean change score on the Body Appreciation Scale (scale scoring 1-5; higher scores indicate greater body appreciation)
Time Frame Baseline to Week 26

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [scores on a scale]
0.8
(0.1)
0.5
(0.1)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.13
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.3
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.2
Estimation Comments
24. Other Pre-specified Outcome
Title Body Dissatisfaction
Description Estimated mean change score on the Body Areas Satisfaction Subscale of the Multidimensional Body-Self Relations Questionnaire-Appearance Scales (scale scoring 1-5; higher scores indicating greater satisfaction)
Time Frame Baseline to Week 12

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [scores on a scale]
0.4
(0.1)
0.4
(0.1)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.53
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.1
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.1
Estimation Comments
25. Other Pre-specified Outcome
Title Body Dissatisfaction
Description Estimated mean change score on the Body Areas Satisfaction Subscale of the Multidimensional Body-Self Relations Questionnaire-Appearance Scales (scale scoring 1-5; higher scores indicating greater satisfaction)
Time Frame Baseline to Week 26

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [scores on a scale]
0.6
(0.1)
0.5
(0.1)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.24
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.2
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.2
Estimation Comments
26. Other Pre-specified Outcome
Title Disordered Eating
Description Estimated mean change score on the Eating Disorders Examination Questionnaire for Global score and four subscales of Eating Restraint, Eating Concern, Weight Concern, and Shape Concern (scale scoring 0-6 for Global score and all subscales; higher scores indicate greater pathology)
Time Frame Baseline to Week 12

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Global
-0.2
(0.1)
-0.2
(0.1)
Eating Restraint
1.7
(0.2)
1.5
(0.2)
Eating Concern
-0.4
(0.2)
-0.7
(0.2)
Weight Concern
-0.7
(0.2)
-0.7
(0.2)
Shape Concern
-1.1
(0.2)
-0.9
(0.2)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Global
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.83
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.0
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.2
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Eating Restraint
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.69
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.1
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.3
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Eating Concern
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.30
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.3
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.3
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Weight Concern
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.99
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.0
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.3
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Shape Concern
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.36
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.3
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.3
Estimation Comments
27. Other Pre-specified Outcome
Title Disordered Eating
Description Estimated mean change score on the Eating Disorders Examination Questionnaire for Global score and four subscales of Eating Restraint, Eating Concern, Weight Concern, and Shape Concern (scale scoring 0-6 for Global score and all subscales; higher scores indicate greater pathology)
Time Frame Baseline to Week 26

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Global
-0.5
(0.1)
-0.3
(0.1)
Eating Restraint
1.2
(0.2)
1.0
(0.2)
Eating Concern
-0.7
(0.2)
-0.6
(0.2)
Weight Concern
-1.2
(0.2)
-0.8
(0.2)
Shape Concern
-1.4
(0.2)
-1.0
(0.2)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Global
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.30
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.2
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.2
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Eating Restraint
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.69
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.1
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.3
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Eating Concern
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.70
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.1
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.3
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Weight Concern
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.26
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.4
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.3
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Shape Concern
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.18
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.4
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.3
Estimation Comments
28. Other Pre-specified Outcome
Title Eating Behaviors
Description Estimated mean change score on the Eating Inventory Questionnaire for three subscales of Dietary Restraint (summed 0-21), Disinhibition (summed 0-16), and Hunger (summed 0-14); higher values indicate greater restraint/disinhibition/hunger
Time Frame Baseline to Week 12

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Dietary Restraint
6.3
(0.7)
5.9
(0.7)
Disinhibition
-2.8
(0.6)
-1.9
(0.6)
Hunger
-3.2
(0.5)
-1.4
(0.5)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Dietary Restraint
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.69
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.4
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.0
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Disinhibition
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.28
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.9
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.8
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Hunger
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.02
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.8
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.8
Estimation Comments
29. Other Pre-specified Outcome
Title Eating Behaviors
Description Estimated mean change score on the Eating Inventory Questionnaire for three subscales of Dietary Restraint (summed 0-21), Disinhibition (summed 0-16), and Hunger (summed 0-14); higher values indicate greater restraint/disinhibition/hunger
Time Frame Baseline to Week 26

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Dietary Restraint
6.4
(0.8)
5.2
(0.8)
Disinhibition
-3.0
(0.6)
-2.2
(0.6)
Hunger
-3.9
(0.5)
-1.4
(0.5)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Dietary Restraint
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.29
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.2
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.1
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Disinhibition
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.34
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.8
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.8
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Hunger
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.001
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.5
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.8
Estimation Comments
30. Other Pre-specified Outcome
Title Anxiety
Description Estimated mean change score on the Generalized Anxiety Disorder-7 Questionnaire (summed 0-21; higher scores indicate greater anxiety)
Time Frame Baseline to Week 12

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [scores on a scale]
-1.8
(0.8)
-0.7
(0.8)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.32
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.1
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.1
Estimation Comments
31. Other Pre-specified Outcome
Title Anxiety
Description Estimated mean change score on the Generalized Anxiety Disorder-7 Questionnaire (summed 0-21; higher scores indicate greater anxiety)
Time Frame Baseline to Week 26

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [scores on a scale]
-1.6
(0.8)
-0.8
(0.8)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.16
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.8
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.2
Estimation Comments
32. Other Pre-specified Outcome
Title Dietary Monitoring
Description Estimated mean change in number of days recording caloric intake
Time Frame Baseline to Week 12

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [number of days]
52.9
(3.4)
55.5
(3.4)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.59
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.6
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 4.8
Estimation Comments
33. Other Pre-specified Outcome
Title Dietary Monitoring
Description Estimated mean change in number of days recording caloric intake
Time Frame Baseline to Week 26

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [number of days]
85.6
(9.5)
95.8
(9.2)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.44
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -10.2
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 13.1
Estimation Comments
34. Other Pre-specified Outcome
Title Self-Reported Self-Monitoring Behaviors
Description Estimated mean change in self-reported frequency of tracking of: weight, food/drink, calories, and physical activity; 0-4 rating for each of the four behaviors (higher scores indicate greater self-reported frequency of self-monitoring behavior)
Time Frame Baseline to Week 12

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Self-Reported Weighing
0.9
(0.2)
1.1
(0.2)
Track Food/Drink
2.7
(0.3)
2.0
(0.3)
Track Calories
2.0
(0.3)
1.7
(0.3)
Track Activity
1.6
(0.3)
0.8
(0.3)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Self-Reported Weighing
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.46
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.2
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.3
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Track Food/Drink
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.12
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.7
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.4
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Track Calories
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.42
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.3
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.4
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Track Activity
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.03
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.8
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.4
Estimation Comments
35. Other Pre-specified Outcome
Title Self-Reported Self-Monitoring Behaviors
Description Estimated mean change in self-reported frequency of tracking of: weight, food/drink, calories, and physical activity; 0-4 rating for each of the four behaviors (higher scores indicate greater self-reported frequency of self-monitoring behavior)
Time Frame Baseline to Week 26

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Self-Reported Weighing
1.0
(0.2)
0.6
(0.2)
Track Food/Drink
1.6
(0.3)
1.6
(0.3)
Track Calories
1.7
(0.3)
1.4
(0.3)
Track Activity
1.3
(0.3)
0.9
(0.3)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Self-Reported Weighing
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.23
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.4
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.3
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Track Food/Drink
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.90
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.1
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.4
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Track Calories
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.36
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.3
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.5
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Track Activity
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.29
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.5
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.4
Estimation Comments
36. Other Pre-specified Outcome
Title Weight Bias Internalization
Description Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)
Time Frame Baseline to week 52

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [scores on scale]
-1.5
(0.2)
-1.2
(0.2)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.25
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.3
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.3
Estimation Comments
37. Other Pre-specified Outcome
Title Weight Self-Stigma Questionnaire (WSSQ)
Description Estimated mean change score for Total score (WSSQ-Total, summed 12-60) and two subscales of Self-Devaluation (WSSQ-SD) and Fear of Enacted Stigma (WSSQ-FNE) (summed 6-30); higher scores indicate greater weight self-stigma
Time Frame Baseline to week 52

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
WSSQ-Total
-5.6
(1.6)
-3.1
(1.6)
WSSQ-SD
-2.9
(0.8)
-1.2
(0.8)
WSSQ-FNE
-2.7
(1.0)
-2.0
(1.0)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments WSSQ-Total
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.27
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.5
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 2.2
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments WSSQ-SD
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.13
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.8
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.2
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments WSSQ-FNE
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.65
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.6
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.4
Estimation Comments
38. Other Pre-specified Outcome
Title Weight Bias
Description Estimated mean change score on the Fat Phobia Scale (scale scoring 1-5; higher scores indicate greater weight bias)
Time Frame Baseline to week 52

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [scores on scale]
-0.4
(0.1)
-0.2
(0.1)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.21
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.2
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.2
Estimation Comments
39. Other Pre-specified Outcome
Title Depression
Description Estimated mean change score on the Patient Health Questionnaire - 9 (summed 0-27; higher scores indicate more symptoms of depression)
Time Frame Baseline to week 52

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [scores on scale]
-2.9
(0.9)
-2.4
(0.9)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.7
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.5
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.2
Estimation Comments
40. Other Pre-specified Outcome
Title Perceived Stress
Description Estimated mean change score on the Perceived Stress Scale (summed 0-40; higher scores indicate greater perceived stress)
Time Frame Baseline to week 52

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [scores on scale]
-2.4
(1.3)
-0.1
(1.2)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.2
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.3
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.8
Estimation Comments
41. Other Pre-specified Outcome
Title Exercise Self-Efficacy
Description Estimated mean change score on the Self-Efficacy for Exercise Scale (summed 0-90; higher scores indicate greater self-efficacy)
Time Frame Baseline to week 52

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [scores on a scale]
-3.1
(4.9)
-6.8
(4.8)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.59
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.7
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 6.9
Estimation Comments
42. Other Pre-specified Outcome
Title Weight-Related Quality of Life
Description Estimated mean change score on the Impact of Weight on Quality of Life Questionnaire-Lite for Total score and five subscales of Physical Function, Self Esteem, Sexual Life, Work, and Public Distress (transformed scores 0-100; higher scores indicate better quality of life)
Time Frame Baseline to week 52

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Total
14.3
(2.5)
13.4
(2.5)
Physical Function
12.4
(3.1)
13.2
(3.1)
Self Esteem
20.0
(3.9)
17.7
(3.9)
Sexual Life
13.3
(3.7)
11.6
(3.6)
Work
12.1
(3.1)
11.8
(3.1)
Public Distress
12.6
(2.7)
7.6
(2.7)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Total
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.81
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.9
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 3.5
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Physical Function
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.86
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.8
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 4.4
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Self Esteem
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.87
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.2
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 7.0
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Sexual Life
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.73
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.8
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 5.2
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Work
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.95
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.3
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 4.4
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Public Distress
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.19
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 5.0
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 3.8
Estimation Comments
43. Other Pre-specified Outcome
Title Eating Self-Efficacy
Description Estimated mean change score on the Weight and Lifestyle Efficacy - Short Form (summed 0-80; higher scores indicate greater self-efficacy)
Time Frame Baseline to week 52

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [scores on scale]
8.3
(3.4)
1.0
(3.4)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.14
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 7.3
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 4.9
Estimation Comments
44. Other Pre-specified Outcome
Title Percent Weight Change
Description Estimated mean change in percent weight change. Weight measured in kilograms (kg)
Time Frame Baseline to week 52

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [percent weight change]
-3.1
(1.0)
-4.0
(1.0)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.53
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.9
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.5
Estimation Comments
45. Other Pre-specified Outcome
Title Waist Circumference
Description Estimated mean change in waist circumference (cm)
Time Frame Baseline to week 52

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [change in cm]
-4.4
(1.0)
-4.4
(1.0)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.99
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.0
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.5
Estimation Comments
46. Other Pre-specified Outcome
Title Blood Pressure
Description Estimated mean change in blood pressure (systolic blood pressure and diastolic blood pressure; mmHg), controlling for blood pressure medication.
Time Frame Baseline to week 52

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Systolic Blood Pressure
-5.7
(2.5)
-4.3
(2.5)
Diastolic Blood Pressure
-1.1
(1.3)
-1.8
(1.3)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Systolic Blood Pressure
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.71
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.4
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 3.6
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Diastolic Blood Pressure
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.72
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.7
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.9
Estimation Comments
47. Other Pre-specified Outcome
Title Body Esteem
Description Estimated mean change score on the Body Appreciation Scale (scale scoring 1-5; higher scores indicate greater body appreciation)
Time Frame Baseline to Week 52

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [scores on a scale]
0.8
(0.1)
0.4
(0.1)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.07
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.4
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.2
Estimation Comments
48. Other Pre-specified Outcome
Title Coping Behaviors in Response to Weight Stigma
Description Estimated mean change score on the Coping with Weight Stigma Questionnaire for Full scale and four subscales of Negative Affect, Maladaptive Eating, Healthy Lifestyle, and Exercise Avoidance (scale scoring 0-4 for Full scale and all subscales); higher scores indicate greater endorsement of coping strategies
Time Frame Baseline to Week 52

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Full Scale
-0.7
(0.1)
-0.6
(0.1)
Negative Affect
-1.2
(0.1)
-0.8
(0.1)
Maladaptive Eating
-0.6
(0.1)
-0.6
(0.1)
Exercise Avoidance
-0.7
(0.3)
-0.6
(0.3)
Healthy Lifestyle
-0.2
(0.2)
0.0
(0.2)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Full Scale
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.52
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.1
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.2
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Negative Affect
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.02
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.5
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.2
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Maladaptive Eating
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.63
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.1
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.2
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Exercise Avoidance
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.74
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.1
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.4
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Healthy Lifestyle
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.49
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.2
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.3
Estimation Comments
49. Other Pre-specified Outcome
Title Body Dissatisfaction
Description Estimated mean change score on the Body Areas Satisfaction Subscale of the Multidimensional Body-Self Relations Questionnaire-Appearance Scales (scale scoring 1-5; higher scores indicating greater satisfaction)
Time Frame Baseline to Week 52

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [scores on a scale]
0.5
(0.1)
0.4
(0.1)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.33
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.2
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.2
Estimation Comments
50. Other Pre-specified Outcome
Title Anxiety
Description Estimated mean change score on the Generalized Anxiety Disorder-7 Questionnaire (summed 0-21; higher scores indicate greater anxiety)
Time Frame Baseline to Week 52

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [scores on a scale]
-1.5
(0.9)
-0.3
(0.9)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.11
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.2
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.2
Estimation Comments
51. Other Pre-specified Outcome
Title Disordered Eating
Description Estimated mean change score on the Eating Disorders Examination Questionnaire for Global score and four subscales of Eating Restraint, Eating Concern, Weight Concern, and Shape Concern (scale scoring 0-6 for Global score and all subscales; higher scores indicate greater pathology)
Time Frame Baseline to Week 52

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Global
-0.4
(0.1)
-0.2
(0.1)
Eating Restraint
1.0
(0.3)
0.7
(0.3)
Eating Concern
-0.6
(0.2)
-0.3
(0.2)
Weight Concern
-1.0
(0.2)
-0.7
(0.2)
Shape Concern
-1.1
(0.2)
-0.7
(0.2)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Global
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.35
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.2
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.2
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Eating Restraint
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.46
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.3
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.4
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Eating Concern
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.33
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.3
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.3
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Weight Concern
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.18
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.4
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.3
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Shape Concern
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.16
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.5
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.3
Estimation Comments
52. Other Pre-specified Outcome
Title Eating Behaviors
Description Estimated mean change score on the Eating Inventory Questionnaire for three subscales of Dietary Restraint (summed 0-21), Disinhibition (summed 0-16), and Hunger (summed 0-14); higher values indicate greater restraint/disinhibition/hunger
Time Frame Baseline to Week 52

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Dietary Restraint
3.5
(0.9)
3.2
(0.9)
Disinhibition
-1.8
(0.5)
-1.2
(0.6)
Hunger
-2.9
(0.6)
-0.7
(0.6)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Dietary Restraint
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.82
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.3
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 1.3
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Disinhibition
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.45
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.6
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.8
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Hunger
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.007
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.2
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.8
Estimation Comments
53. Other Pre-specified Outcome
Title Self-Reported Self-Monitoring Behaviors
Description Estimated mean change in self-reported frequency of tracking of: weight, food/drink, calories, and physical activity; 0-4 rating for each of the four behaviors (higher scores indicate greater self-reported frequency of self-monitoring behavior)
Time Frame Baseline to Week 52

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Self-Reported Weighing
0.9
(0.2)
0.5
(0.2)
Track Food/Drink
0.8
(0.2)
0.7
(0.2)
Track Calories
1.2
(0.3)
1.3
(0.3)
Track Activity
0.8
(0.3)
0.3
(0.3)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Self-Reported Weighing
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.23
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.4
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.3
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Track Food/Drink
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.48
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.1
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.3
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Track Calories
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.89
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.2
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.4
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments Track Activity
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.30
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.4
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.5
Estimation Comments
54. Other Pre-specified Outcome
Title Treatment Acceptability Ratings
Description To assess treatment acceptability, participants in both groups rated (1-7) the BWL treatment, as well as the stigma intervention (i.e., BIAS component) or recipe exchange, on how helpful they found each component of the program, how much they liked the components, and how much they learned new skills or information from each component. Scores for these three items were averaged (1-7) separately for the BWL treatment, BIAS component, and recipe exchange. Higher scores indicate greater treatment acceptability.
Time Frame Week 26

Outcome Measure Data

Analysis Population Description
Participants randomized to the BWL + BIAS group did not receive (and thus did not rate) the recipe exchange component of treatment. Participants in the Standard BWL group did not receive (and did not rate) the BIAS treatment component.
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
BWL component
6.5
(0.9)
6.3
(1.0)
BIAS component
6.3
(1.0)
Recipe exchange
5.4
(1.5)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments BWL component
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.32
Comments
Method ANOVA
Comments
55. Other Pre-specified Outcome
Title Treatment Acceptability Ratings
Description To assess treatment acceptability, participants rated (1-7) 5 items to indicate the extent to which they found the program (as a whole) to be helpful and acceptable, and how much they liked, were satisfied with, and would recommend the program to others. Scores are averaged 1-7, with higher scores indicating greater treatment acceptability.
Time Frame Week 52

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
Measure Participants 36 36
Mean (Standard Error) [scores on a scale]
6.5
(0.6)
6.2
(0.9)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BWL + BIAS, Standard BWL
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.14
Comments
Method ANOVA
Comments

Adverse Events

Time Frame Week 1 through week 26
Adverse Event Reporting Description At each contact with participants, study personnel non-systematically collected information on any adverse events (AEs) self-reported by participants. In addition, AEs were systematically assessed at the scheduled assessments. AEs were documented by study staff in consultation with a nurse practitioner and/or physician. Serious adverse events (SAEs) were reported immediately to the study sponsor, Data and Safety Monitor, and the Institutional Review Board.
Arm/Group Title BWL + BIAS Standard BWL
Arm/Group Description In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26. In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
All Cause Mortality
BWL + BIAS Standard BWL
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/36 (0%) 0/36 (0%)
Serious Adverse Events
BWL + BIAS Standard BWL
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/36 (0%) 1/36 (2.8%)
Renal and urinary disorders
Hypokalemia 0/36 (0%) 0 1/36 (2.8%) 1
Other (Not Including Serious) Adverse Events
BWL + BIAS Standard BWL
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 3/36 (8.3%) 7/36 (19.4%)
Gastrointestinal disorders
Viral gastroenteritis 1/36 (2.8%) 1 3/36 (8.3%) 3
Musculoskeletal and connective tissue disorders
Back pain 0/36 (0%) 0 2/36 (5.6%) 2
Knee pain 0/36 (0%) 0 2/36 (5.6%) 2
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation 2/36 (5.6%) 2 0/36 (0%) 0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. Rebecca Pearl
Organization Perelman School of Medicine at the University of Pennsylvania
Phone 215-746-5129
Email rpearl@pennmedicine.upenn.edu
Responsible Party:
Rebecca L. Pearl, Ph.D., Assistant Professor, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT03572218
Other Study ID Numbers:
  • 829070
First Posted:
Jun 28, 2018
Last Update Posted:
Oct 23, 2020
Last Verified:
Sep 1, 2020