Project Impact: An Innovative Approach to Weight Loss Maintenance
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 |
---|---|---|
|
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
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
- 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
- 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
- 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.
- Waist Circumference [Baseline, 6 months, 12 months, 18 months, 24 months, 36 months]
Measured in the clinical horizontally at the umbilicus.
Other Outcome Measures
- 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).
- 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.
- 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.
- 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
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.- 1402002613
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
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. |
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. |
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. |
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. |
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 |
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 |
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 |
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 |
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 |
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
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 |
mlb34@drexel.edu |
- 1402002613