Project Impact: An Innovative Approach to Weight Loss Maintenance

Sponsor
Drexel University (Other)
Overall Status
Completed
CT.gov ID
NCT02363010
Collaborator
(none)
320
1
3
89
3.6

Study Details

Study Description

Brief Summary

The major goal of this project is to evaluate an innovative approach to obesity. This study will determine if behavioral treatment can be improved by 1) implementing a primary focus on PA following initial weight loss treatment, and 2) using a novel, acceptance-based approach to the promotion of PA.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Gold Standard Behavior Therapy for Weight Loss
  • Behavioral: Behavior Therapy for Weight Loss with Physical Activity Emphasis
  • Behavioral: Acceptance-based Behavior Therapy for Weight Loss with PA emphasis
N/A

Detailed Description

Most adults who engage in lifestyle modification find it difficult to maintain a high level of PA over the long-term, and most also find that weight regain is inevitable. The current portfolio of available interventions does not adequately address these challenges. This project is designed to test the effectiveness of an intervention that is specifically designed to enhance the ability to maintain, in the long-term, a level of PA high enough to achieve long-term weight loss maintenance.

In the study, 300 obese adults will be recruited from the community and provided with 6 months of group-based, standard behavioral treatment for induction of weight loss (Phase I). A 6-month Phase I was chosen so that all participants will have sufficient time to accomplish initial weight loss before Phase II begins, allowing Phase II to truly be a test of weight loss maintenance. In Phase II, participants will receive one of three interventions, to be delivered for an additional 12 months: 1) behavioral treatment, with the standard emphasis on maintaining changes in diet and PA (BT), 2) behavioral treatment, with a primary emphasis on using these skills to maintain PA (BT-PA), or 3) acceptance-based behavioral treatment, with a primary emphasis on using these skills to maintain PA (ABT-PA).

Assessments will be conducted at baseline, 6 months, 18 months (end of treatment), 24 months (6-month follow-up), and 36 months (18-month follow-up).

Study Design

Study Type:
Interventional
Actual Enrollment :
320 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
1R01DK100345-01A1: An Innovative, Physical Activity-focused Approach to Weight Loss Maintenance
Actual Study Start Date :
Aug 1, 2014
Actual Primary Completion Date :
Aug 1, 2019
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard Behavior Therapy for Weight Loss

Eighteen months of standard, group-based behavioral treatment for weight loss and weight loss maintenance.

Behavioral: Gold Standard Behavior Therapy for Weight Loss
Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session).

Experimental: Behavior Therapy for Weight Loss with PA emphasis

Six months of standard, group-based behavioral treatment for weight loss and weight loss maintenance, followed by 12 months of standard, group-based behavioral treatment for weight loss and weight loss maintenance with a larger emphasis on physical activity goals.

Behavioral: Gold Standard Behavior Therapy for Weight Loss
Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session).

Behavioral: Behavior Therapy for Weight Loss with Physical Activity Emphasis
Group-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session).

Experimental: Acceptance-based Behavior Therapy with PA emphasis

Six months of standard, group-based behavioral treatment for weight loss and weight loss maintenance, followed by 12 months of group-based behavior therapy with acceptance-based strategies, and a larger emphasis on physical activity goals.

Behavioral: Gold Standard Behavior Therapy for Weight Loss
Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session).

Behavioral: Acceptance-based Behavior Therapy for Weight Loss with PA emphasis
Group-based, acceptance-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session).

Outcome Measures

Primary Outcome Measures

  1. Change in Body Weight [Baseline, 6 months, 12 months, 18 months, 24 months, 36 months]

    Objectively measured in the research clinic at each time point on a scale

  2. Change in Physical Activity [Baseline, 6 months, 12 months, 18 months, 24 months, 36 months]

    Objectively measured at each time point using wGT3X-BT accelerometers from Actigraph

Secondary Outcome Measures

  1. Cardiorespiratory Fitness [Baseline, 6 months, 12 months, 18 months, 24 months, 36 months]

    Time taken to complete a half-mile walk on the treadmill. Shorter times indicate a greater level of cardiorespiratory fitness.

  2. Waist Circumference [Baseline, 6 months, 12 months, 18 months, 24 months, 36 months]

    Measured in the clinical horizontally at the umbilicus.

Other Outcome Measures

  1. Exploratory Moderator: Emotional Overeating [0 months, 6 months]

    Emotional Overeating Questionnaire (EOQ). The EOQ is a six-item self-report questionnaire designed to assess the frequency of emotional overeating (Masheb & Grilo, 2006). Participants rate their frequency of eating an "unusually large amount" over the prior 28 days in response to anxiety, sadness, loneliness, tiredness, anger, and happiness on a 7-point Likert scale: 0 = no days, 1 =1-5 days, 2 = 6-12 days, 3 = 13-15 days, 4 = 16-22 days, 5 = 23-27 days, and 6 = every day. Responses to the six items are averaged for a total score, with higher scores indicating more frequent emotional overeating. The EOQ has previously shown high internal consistency (alpha = 0.85) with test-retest reliability among individuals with Binge Eating Disorder (Masheb & Grilo, 2006).

  2. Exploratory Moderator: Disinhibited Eating. [0 months, 6 months]

    The 18-item Three Factor Eating Questionnaire (TFEQ) (Cappelleri, Bushmakin, Gerber, Leidy, Sexton, Lowe, et al., 2009) was used to assess disinhibited eating behavior. The questionnaire consists of statements about food and participants rate the extent to which those statements apply to them on a 4-point Likert scale (definitely true, mostly true, mostly false, definitely false). The questionnaire has a well-validated three-factor structure (Cronbach's α of 0.78-0.94), which includes a domain measuring disinhibited eating behavior (Cappelleri, Bushmakin, Gerber, Leidy, Sexton, Lowe, et al., 2009). This subscale consists of 9 items, such as: "Sometimes when I start eating, I just can't seem to stop." Higher scores indicate higher levels of disinhibited eating.

  3. Exploratory Moderator: Hedonic Hunger [0 months, 6 months]

    Hedonic Hunger. The Power of Food Scale (PFS) is a 15-item self-report questionnaire that assesses the tendency to eat for pleasure (rather than physiological hunger) based on cues from the environment (Lowe et al., 2009). Items measure participants' appetite-related thoughts, feelings, and motivations for highly palatable foods and consists of three subscales based on food proximity: (1) Food available in the environment but not physically present, (2) Food physically present but not yet tasted, and (3) Food tasted but not yet consumed. Examples of these items include, "If I see or smell a food I like, I get a powerful urge to have some" and "Just before I taste a favorite food, I feel intense anticipation." Participants rated each of these statements on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Total scores are an average of the 15 responses, with higher scores indicating greater hedonic hunger.

  4. Exploratory Moderator: Appetitive Response to Exercise [0 months, 6 months]

    Perceived Appetitive Response to Exercise. Participants were asked to report which of the following described their experience in the past month: There is no relationship between my level of exercise and my appetite; Exercise helps me control my appetite - I am less hungry when I am exercising regularly; Exercise increases my appetite - I am more hungry when I am exercising regularly; Not applicable because not exercising. This single-item measure was constructed by the research team, as no pre-existing measure of this construct was identified.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Have a BMI between 27 and 45 kg/m2

  • Have the ability to engage in at least 15 minutes of moderate physical activity (e.g. brisk walking)

  • Successfully complete all steps in the enrollment process, including attendance at all pre-randomization clinic visits and providing physician clearance

Exclusion Criteria:
  • Have a medical condition that prevents safe engagement in moderate-to-vigorous physical activity

  • Are lactating, pregnant, or planning to become pregnant in the next three years

  • Report recently beginning a course of or changing the dosage of prescription medications that can cause significant weight loss or weight gain

  • Are participating in or plan to participate in another weight loss program in the next three years

  • Have a primary family member or member of their household participating in the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Drexel University Philadelphia Pennsylvania United States 19130

Sponsors and Collaborators

  • Drexel University

Investigators

  • Principal Investigator: Meghan Butryn, Ph.D., Drexel University

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Meghan Butryn, Principal Investigator, Drexel University
ClinicalTrials.gov Identifier:
NCT02363010
Other Study ID Numbers:
  • 1402002613
First Posted:
Feb 13, 2015
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Keywords provided by Meghan Butryn, Principal Investigator, Drexel University
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Standard Behavior Therapy for Weight Loss Behavior Therapy for Weight Loss With PA Emphasis Acceptance-based Behavior Therapy With PA Emphasis
Arm/Group Description Eighteen months of standard, group-based behavioral treatment for weight loss and weight loss maintenance. Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Six months of standard, group-based behavioral treatment for weight loss and weight loss maintenance, followed by 12 months of standard, group-based behavioral treatment for weight loss and weight loss maintenance with a larger emphasis on physical activity goals. Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Behavior Therapy for Weight Loss with Physical Activity Emphasis: Group-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Six months of standard, group-based behavioral treatment for weight loss and weight loss maintenance, followed by 12 months of group-based behavior therapy with acceptance-based strategies, and a larger emphasis on physical activity goals. Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Acceptance-based Behavior Therapy for Weight Loss with PA emphasis: Group-based, acceptance-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session).
Period Title: Overall Study
STARTED 110 105 105
COMPLETED 88 94 89
NOT COMPLETED 22 11 16

Baseline Characteristics

Arm/Group Title Standard Behavior Therapy for Weight Loss Behavior Therapy for Weight Loss With PA Emphasis Acceptance-based Behavior Therapy With PA Emphasis Total
Arm/Group Description Eighteen months of standard, group-based behavioral treatment for weight loss and weight loss maintenance. Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Six months of standard, group-based behavioral treatment for weight loss and weight loss maintenance, followed by 12 months of standard, group-based behavioral treatment for weight loss and weight loss maintenance with a larger emphasis on physical activity goals. Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Behavior Therapy for Weight Loss with Physical Activity Emphasis: Group-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Six months of standard, group-based behavioral treatment for weight loss and weight loss maintenance, followed by 12 months of group-based behavior therapy with acceptance-based strategies, and a larger emphasis on physical activity goals. Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Acceptance-based Behavior Therapy for Weight Loss with PA emphasis: Group-based, acceptance-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Total of all reporting groups
Overall Participants 110 105 105 320
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
0
0%
Between 18 and 65 years
95
86.4%
96
91.4%
98
93.3%
289
90.3%
>=65 years
15
13.6%
9
8.6%
7
6.7%
31
9.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
51.3
(11.4)
54.3
(9.01)
52.7
(10.4)
52.7
(10.4)
Sex: Female, Male (Count of Participants)
Female
90
81.8%
78
74.3%
82
78.1%
250
78.1%
Male
20
18.2%
27
25.7%
23
21.9%
70
21.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
3
2.7%
5
4.8%
4
3.8%
12
3.8%
Not Hispanic or Latino
107
97.3%
99
94.3%
101
96.2%
307
95.9%
Unknown or Not Reported
0
0%
1
1%
0
0%
1
0.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
2
1.9%
2
0.6%
Asian
1
0.9%
3
2.9%
1
1%
5
1.6%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
0
0%
Black or African American
28
25.5%
26
24.8%
26
24.8%
80
25%
White
78
70.9%
73
69.5%
73
69.5%
224
70%
More than one race
3
2.7%
3
2.9%
3
2.9%
9
2.8%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
Region of Enrollment (participants) [Number]
United States
110
100%
105
100%
105
100%
320
100%
BMI (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]
35.1
(4.3)
34.5
(4.6)
35.8
(5.3)
35.1
(4.8)

Outcome Measures

1. Primary Outcome
Title Change in Body Weight
Description Objectively measured in the research clinic at each time point on a scale
Time Frame Baseline, 6 months, 12 months, 18 months, 24 months, 36 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Standard Behavior Therapy for Weight Loss Behavior Therapy for Weight Loss With PA Emphasis Acceptance-based Behavior Therapy With PA Emphasis
Arm/Group Description Eighteen months of standard, group-based behavioral treatment for weight loss and weight loss maintenance. Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Six months of standard, group-based behavioral treatment for weight loss and weight loss maintenance, followed by 12 months of standard, group-based behavioral treatment for weight loss and weight loss maintenance with a larger emphasis on physical activity goals. Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Behavior Therapy for Weight Loss with Physical Activity Emphasis: Group-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Six months of standard, group-based behavioral treatment for weight loss and weight loss maintenance, followed by 12 months of group-based behavior therapy with acceptance-based strategies, and a larger emphasis on physical activity goals. Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Acceptance-based Behavior Therapy for Weight Loss with PA emphasis: Group-based, acceptance-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session).
Measure Participants 110 105 105
6 Months
10.5
(5.6)
10.2
(5.0)
9.9
(4.7)
12 Months
12.3
(8.9)
12.8
(8.2)
11.6
(7.8)
18 months
10.2
(11.9)
12.4
(10.1)
9.1
(10.3)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Behavior Therapy for Weight Loss, Behavior Therapy for Weight Loss With PA Emphasis, Acceptance-based Behavior Therapy With PA Emphasis
Comments Exploring group differences in 12 month weight losses.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value .68
Comments A prior threshold for statistical significance was p < .05.
Method ANOVA
Comments Controlling for baseline weight.
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard Behavior Therapy for Weight Loss, Behavior Therapy for Weight Loss With PA Emphasis, Acceptance-based Behavior Therapy With PA Emphasis
Comments Exploring group differences in 18 month weight losses.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value .11
Comments A prior threshold for significance was p<.05.
Method ANOVA
Comments Controlling for baseline weight.
2. Primary Outcome
Title Change in Physical Activity
Description Objectively measured at each time point using wGT3X-BT accelerometers from Actigraph
Time Frame Baseline, 6 months, 12 months, 18 months, 24 months, 36 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Standard Behavior Therapy for Weight Loss Behavior Therapy for Weight Loss With PA Emphasis Acceptance-based Behavior Therapy With PA Emphasis
Arm/Group Description Eighteen months of standard, group-based behavioral treatment for weight loss and weight loss maintenance. Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Six months of standard, group-based behavioral treatment for weight loss and weight loss maintenance, followed by 12 months of standard, group-based behavioral treatment for weight loss and weight loss maintenance with a larger emphasis on physical activity goals. Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Behavior Therapy for Weight Loss with Physical Activity Emphasis: Group-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Six months of standard, group-based behavioral treatment for weight loss and weight loss maintenance, followed by 12 months of group-based behavior therapy with acceptance-based strategies, and a larger emphasis on physical activity goals. Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Acceptance-based Behavior Therapy for Weight Loss with PA emphasis: Group-based, acceptance-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session).
Measure Participants 110 105 105
Baseline
64.2
(91.9)
64.2
(78.6)
48.6
(73.6)
6 Months
133.9
(124.5)
143.0
(121.0)
128.8
(115.7)
12 Months
129.1
(117.5)
144.6
(124.9)
127.3
(126.9)
18 Months
110.0
(134.6)
102.5
(124.0)
85.9
(101.7)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Behavior Therapy for Weight Loss, Behavior Therapy for Weight Loss With PA Emphasis
Comments Exploring group differences in 12 month moderator to vigorous physical activity (MVPA).
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value .41
Comments A priori threshold for statistical significance was p < .05.
Method Compound Poisson general linear models
Comments Controlling for baseline MVPA.
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard Behavior Therapy for Weight Loss, Acceptance-based Behavior Therapy With PA Emphasis
Comments Exploring group differences in 12 month MVPA.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value .46
Comments A priori threshold for statistical significance was p < .05.
Method Compound Poisson general linear models
Comments Controlling for baseline MVPA.
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Behavior Therapy for Weight Loss With PA Emphasis, Acceptance-based Behavior Therapy With PA Emphasis
Comments Exploring group differences in 12 month MVPA.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value .82
Comments A priori threshold for statistical significance was p< .05.
Method Compound Poisson general linear models
Comments Controlling for baseline MVPA.
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Standard Behavior Therapy for Weight Loss, Behavior Therapy for Weight Loss With PA Emphasis
Comments Exploring group differences in 18 month MVPA.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value .42
Comments A priori threshold for statistical significance was p < .05.
Method Compound Poisson general linear models
Comments Controlling for baseline MVPA.
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Standard Behavior Therapy for Weight Loss, Acceptance-based Behavior Therapy With PA Emphasis
Comments Exploring group differences in 18 month MVPA.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value .28
Comments A priori threshold for statistical significance was p < .05.
Method Compound Poisson general linear models
Comments Controlling for baseline MVPA.
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Behavior Therapy for Weight Loss With PA Emphasis, Acceptance-based Behavior Therapy With PA Emphasis
Comments Exploring group differences in 18 month MVPA.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value .82
Comments A priori threshold for statistical significance was p < .05.
Method Compound Poisson general linear models
Comments Controlling for baseline MVPA.
3. Secondary Outcome
Title Cardiorespiratory Fitness
Description Time taken to complete a half-mile walk on the treadmill. Shorter times indicate a greater level of cardiorespiratory fitness.
Time Frame Baseline, 6 months, 12 months, 18 months, 24 months, 36 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Standard Behavior Therapy for Weight Loss Behavior Therapy for Weight Loss With PA Emphasis Acceptance-based Behavior Therapy With PA Emphasis
Arm/Group Description Eighteen months of standard, group-based behavioral treatment for weight loss and weight loss maintenance. Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Six months of standard, group-based behavioral treatment for weight loss and weight loss maintenance, followed by 12 months of standard, group-based behavioral treatment for weight loss and weight loss maintenance with a larger emphasis on physical activity goals. Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Behavior Therapy for Weight Loss with Physical Activity Emphasis: Group-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Six months of standard, group-based behavioral treatment for weight loss and weight loss maintenance, followed by 12 months of group-based behavior therapy with acceptance-based strategies, and a larger emphasis on physical activity goals. Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Acceptance-based Behavior Therapy for Weight Loss with PA emphasis: Group-based, acceptance-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session).
Measure Participants 110 105 105
Baseline
537.1
(98.2)
576.6
(157.3)
562.2
(101.8)
6 months
503.9
(80.8)
528.2
(103.7)
514.1
(73.1)
12 months
487.7
(74.7)
512.2
(96.5)
500.5
(77.5)
18 months
498.0
(80.9)
518.4
(107.6)
517.0
(103.7)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Behavior Therapy for Weight Loss, Behavior Therapy for Weight Loss With PA Emphasis, Acceptance-based Behavior Therapy With PA Emphasis
Comments Exploring group differences in 12 month cardiorespiratory fitness, measured by half-mile walk time.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value .06
Comments A priori threshold for statistical significance was p < .05.
Method ANOVA
Comments Controlling for baseline half-mile walk time.
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard Behavior Therapy for Weight Loss, Behavior Therapy for Weight Loss With PA Emphasis, Acceptance-based Behavior Therapy With PA Emphasis
Comments Exploring group differences in 18 month cardiorespiratory fitness, measured by half-mile walk time.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value .30
Comments A priori threshold for statistical significance was p < .05.
Method ANOVA
Comments Controlling for baseline half-mile walk time.
4. Secondary Outcome
Title Waist Circumference
Description Measured in the clinical horizontally at the umbilicus.
Time Frame Baseline, 6 months, 12 months, 18 months, 24 months, 36 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Standard Behavior Therapy for Weight Loss Behavior Therapy for Weight Loss With PA Emphasis Acceptance-based Behavior Therapy With PA Emphasis
Arm/Group Description Eighteen months of standard, group-based behavioral treatment for weight loss and weight loss maintenance. Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Six months of standard, group-based behavioral treatment for weight loss and weight loss maintenance, followed by 12 months of standard, group-based behavioral treatment for weight loss and weight loss maintenance with a larger emphasis on physical activity goals. Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Behavior Therapy for Weight Loss with Physical Activity Emphasis: Group-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Six months of standard, group-based behavioral treatment for weight loss and weight loss maintenance, followed by 12 months of group-based behavior therapy with acceptance-based strategies, and a larger emphasis on physical activity goals. Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Acceptance-based Behavior Therapy for Weight Loss with PA emphasis: Group-based, acceptance-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session).
Measure Participants 110 105 105
Baseline
42.6
(5.5)
42.6
(4.7)
41.8
(4.5)
6 Months
39.0
(5.1)
39.7
(4.8)
38.9
(4.3)
12 Months
38.6
(5.2)
38.8
(4.9)
38.2
(4.6)
18 Months
39.2
(5.8)
38.9
(5.3)
38.5
(4.7)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Behavior Therapy for Weight Loss, Behavior Therapy for Weight Loss With PA Emphasis, Acceptance-based Behavior Therapy With PA Emphasis
Comments Exploring group differences in 12 month waist circumference.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value .59
Comments A priori threshold for statistical significance was p < .05.
Method ANOVA
Comments Controlling for baseline waist circumference.
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard Behavior Therapy for Weight Loss, Behavior Therapy for Weight Loss With PA Emphasis, Acceptance-based Behavior Therapy With PA Emphasis
Comments Exploring group differences in 18 month waist circumference.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value .57
Comments A priori threshold for statistical significance was p < .05.
Method ANOVA
Comments Controlling for baseline waist circumference.
5. Other Pre-specified Outcome
Title Exploratory Moderator: Emotional Overeating
Description Emotional Overeating Questionnaire (EOQ). The EOQ is a six-item self-report questionnaire designed to assess the frequency of emotional overeating (Masheb & Grilo, 2006). Participants rate their frequency of eating an "unusually large amount" over the prior 28 days in response to anxiety, sadness, loneliness, tiredness, anger, and happiness on a 7-point Likert scale: 0 = no days, 1 =1-5 days, 2 = 6-12 days, 3 = 13-15 days, 4 = 16-22 days, 5 = 23-27 days, and 6 = every day. Responses to the six items are averaged for a total score, with higher scores indicating more frequent emotional overeating. The EOQ has previously shown high internal consistency (alpha = 0.85) with test-retest reliability among individuals with Binge Eating Disorder (Masheb & Grilo, 2006).
Time Frame 0 months, 6 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
6. Other Pre-specified Outcome
Title Exploratory Moderator: Disinhibited Eating.
Description The 18-item Three Factor Eating Questionnaire (TFEQ) (Cappelleri, Bushmakin, Gerber, Leidy, Sexton, Lowe, et al., 2009) was used to assess disinhibited eating behavior. The questionnaire consists of statements about food and participants rate the extent to which those statements apply to them on a 4-point Likert scale (definitely true, mostly true, mostly false, definitely false). The questionnaire has a well-validated three-factor structure (Cronbach's α of 0.78-0.94), which includes a domain measuring disinhibited eating behavior (Cappelleri, Bushmakin, Gerber, Leidy, Sexton, Lowe, et al., 2009). This subscale consists of 9 items, such as: "Sometimes when I start eating, I just can't seem to stop." Higher scores indicate higher levels of disinhibited eating.
Time Frame 0 months, 6 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
7. Other Pre-specified Outcome
Title Exploratory Moderator: Hedonic Hunger
Description Hedonic Hunger. The Power of Food Scale (PFS) is a 15-item self-report questionnaire that assesses the tendency to eat for pleasure (rather than physiological hunger) based on cues from the environment (Lowe et al., 2009). Items measure participants' appetite-related thoughts, feelings, and motivations for highly palatable foods and consists of three subscales based on food proximity: (1) Food available in the environment but not physically present, (2) Food physically present but not yet tasted, and (3) Food tasted but not yet consumed. Examples of these items include, "If I see or smell a food I like, I get a powerful urge to have some" and "Just before I taste a favorite food, I feel intense anticipation." Participants rated each of these statements on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Total scores are an average of the 15 responses, with higher scores indicating greater hedonic hunger.
Time Frame 0 months, 6 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
8. Other Pre-specified Outcome
Title Exploratory Moderator: Appetitive Response to Exercise
Description Perceived Appetitive Response to Exercise. Participants were asked to report which of the following described their experience in the past month: There is no relationship between my level of exercise and my appetite; Exercise helps me control my appetite - I am less hungry when I am exercising regularly; Exercise increases my appetite - I am more hungry when I am exercising regularly; Not applicable because not exercising. This single-item measure was constructed by the research team, as no pre-existing measure of this construct was identified.
Time Frame 0 months, 6 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
9. Other Pre-specified Outcome
Title Exploratory Moderator: Appetitive Response to Exercise
Description Perceived Appetitive Response to Exercise. Participants were asked to report which of the following described their experience in the past month: There is no relationship between my level of exercise and my appetite; Exercise helps me control my appetite - I am less hungry when I am exercising regularly; Exercise increases my appetite - I am more hungry when I am exercising regularly; Not applicable because not exercising. This single-item measure was constructed by the research team, as no pre-existing measure of this construct was identified.
Time Frame 0 months, 6 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
10. Other Pre-specified Outcome
Title Exploratory Moderator: Appetitive Response to Exercise
Description Perceived Appetitive Response to Exercise. Participants were asked to report which of the following described their experience in the past month: There is no relationship between my level of exercise and my appetite; Exercise helps me control my appetite - I am less hungry when I am exercising regularly; Exercise increases my appetite - I am more hungry when I am exercising regularly; Not applicable because not exercising. This single-item measure was constructed by the research team, as no pre-existing measure of this construct was identified.
Time Frame 0 months, 6 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description

Adverse Events

Time Frame 36 months
Adverse Event Reporting Description No serious adverse events occurred.
Arm/Group Title Standard Behavior Therapy for Weight Loss Behavior Therapy for Weight Loss With PA Emphasis Acceptance-based Behavior Therapy With PA Emphasis
Arm/Group Description Eighteen months of standard, group-based behavioral treatment for weight loss and weight loss maintenance. Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Six months of standard, group-based behavioral treatment for weight loss and weight loss maintenance, followed by 12 months of standard, group-based behavioral treatment for weight loss and weight loss maintenance with a larger emphasis on physical activity goals. Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Behavior Therapy for Weight Loss with Physical Activity Emphasis: Group-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Six months of standard, group-based behavioral treatment for weight loss and weight loss maintenance, followed by 12 months of group-based behavior therapy with acceptance-based strategies, and a larger emphasis on physical activity goals. Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Acceptance-based Behavior Therapy for Weight Loss with PA emphasis: Group-based, acceptance-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session).
All Cause Mortality
Standard Behavior Therapy for Weight Loss Behavior Therapy for Weight Loss With PA Emphasis Acceptance-based Behavior Therapy With PA Emphasis
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/110 (0%) 0/105 (0%) 0/105 (0%)
Serious Adverse Events
Standard Behavior Therapy for Weight Loss Behavior Therapy for Weight Loss With PA Emphasis Acceptance-based Behavior Therapy With PA Emphasis
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/110 (0%) 0/105 (0%) 0/105 (0%)
Other (Not Including Serious) Adverse Events
Standard Behavior Therapy for Weight Loss Behavior Therapy for Weight Loss With PA Emphasis Acceptance-based Behavior Therapy With PA Emphasis
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/110 (0%) 0/105 (0%) 0/105 (0%)

Limitations/Caveats

High attrition; low power to detect small effects; no measurement of dietary intake; imperfect measurements of physical activity; conditions differed on how eating behavior was addressed; underrepresentation of men, racial groups outside of non-Hispanic White or Black, young adults, older adults, and those with low levels of education; conducted as a high-intensity BWL within an academic research clinic which may differ from lower-intensity or community-based formats.

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. Meghan Butryn
Organization Drexel University
Phone 215-553-7108
Email mlb34@drexel.edu
Responsible Party:
Meghan Butryn, Principal Investigator, Drexel University
ClinicalTrials.gov Identifier:
NCT02363010
Other Study ID Numbers:
  • 1402002613
First Posted:
Feb 13, 2015
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022