Trial Outcomes & Findings for Project Impact: An Innovative Approach to Weight Loss Maintenance (NCT NCT02363010)
NCT ID: NCT02363010
Last Updated: 2023-03-03
Results Overview
Objectively measured in the research clinic at each time point on a scale
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
320 participants
Primary outcome timeframe
Baseline, 6 months, 12 months, 18 months, 24 months, 36 months
Results posted on
2023-03-03
Participant Flow
Participant milestones
| Measure |
Standard Behavior Therapy for Weight Loss
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).
|
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.
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).
|
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.
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).
|
|---|---|---|---|
|
Overall Study
STARTED
|
110
|
105
|
105
|
|
Overall Study
COMPLETED
|
88
|
94
|
89
|
|
Overall Study
NOT COMPLETED
|
22
|
11
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Project Impact: An Innovative Approach to Weight Loss Maintenance
Baseline characteristics by cohort
| Measure |
Standard Behavior Therapy for Weight Loss
n=110 Participants
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).
|
Behavior Therapy for Weight Loss With PA Emphasis
n=105 Participants
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).
|
Acceptance-based Behavior Therapy With PA Emphasis
n=105 Participants
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
n=320 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
95 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
289 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
54.3 years
STANDARD_DEVIATION 9.01 • n=7 Participants
|
52.7 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
52.7 years
STANDARD_DEVIATION 10.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
250 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
107 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
307 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
78 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
224 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
110 participants
n=5 Participants
|
105 participants
n=7 Participants
|
105 participants
n=5 Participants
|
320 participants
n=4 Participants
|
|
BMI
|
35.1 kg/m2
STANDARD_DEVIATION 4.3 • n=5 Participants
|
34.5 kg/m2
STANDARD_DEVIATION 4.6 • n=7 Participants
|
35.8 kg/m2
STANDARD_DEVIATION 5.3 • n=5 Participants
|
35.1 kg/m2
STANDARD_DEVIATION 4.8 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 months, 12 months, 18 months, 24 months, 36 monthsObjectively measured in the research clinic at each time point on a scale
Outcome measures
| Measure |
Standard Behavior Therapy for Weight Loss
n=110 Participants
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).
|
Behavior Therapy for Weight Loss With PA Emphasis
n=105 Participants
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).
|
Acceptance-based Behavior Therapy With PA Emphasis
n=105 Participants
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).
|
|---|---|---|---|
|
Change in Body Weight
6 Months
|
10.5 percent weight loss
Standard Deviation 5.6
|
10.2 percent weight loss
Standard Deviation 5.0
|
9.9 percent weight loss
Standard Deviation 4.7
|
|
Change in Body Weight
12 Months
|
12.3 percent weight loss
Standard Deviation 8.9
|
12.8 percent weight loss
Standard Deviation 8.2
|
11.6 percent weight loss
Standard Deviation 7.8
|
|
Change in Body Weight
18 months
|
10.2 percent weight loss
Standard Deviation 11.9
|
12.4 percent weight loss
Standard Deviation 10.1
|
9.1 percent weight loss
Standard Deviation 10.3
|
PRIMARY outcome
Timeframe: Baseline, 6 months, 12 months, 18 months, 24 months, 36 monthsObjectively measured at each time point using wGT3X-BT accelerometers from Actigraph
Outcome measures
| Measure |
Standard Behavior Therapy for Weight Loss
n=110 Participants
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).
|
Behavior Therapy for Weight Loss With PA Emphasis
n=105 Participants
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).
|
Acceptance-based Behavior Therapy With PA Emphasis
n=105 Participants
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).
|
|---|---|---|---|
|
Change in Physical Activity
Baseline
|
64.2 min per week of MVPA
Standard Deviation 91.9
|
64.2 min per week of MVPA
Standard Deviation 78.6
|
48.6 min per week of MVPA
Standard Deviation 73.6
|
|
Change in Physical Activity
6 Months
|
133.9 min per week of MVPA
Standard Deviation 124.5
|
143.0 min per week of MVPA
Standard Deviation 121.0
|
128.8 min per week of MVPA
Standard Deviation 115.7
|
|
Change in Physical Activity
12 Months
|
129.1 min per week of MVPA
Standard Deviation 117.5
|
144.6 min per week of MVPA
Standard Deviation 124.9
|
127.3 min per week of MVPA
Standard Deviation 126.9
|
|
Change in Physical Activity
18 Months
|
110.0 min per week of MVPA
Standard Deviation 134.6
|
102.5 min per week of MVPA
Standard Deviation 124.0
|
85.9 min per week of MVPA
Standard Deviation 101.7
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 months, 18 months, 24 months, 36 monthsTime taken to complete a half-mile walk on the treadmill. Shorter times indicate a greater level of cardiorespiratory fitness.
Outcome measures
| Measure |
Standard Behavior Therapy for Weight Loss
n=110 Participants
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).
|
Behavior Therapy for Weight Loss With PA Emphasis
n=105 Participants
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).
|
Acceptance-based Behavior Therapy With PA Emphasis
n=105 Participants
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).
|
|---|---|---|---|
|
Cardiorespiratory Fitness
Baseline
|
537.1 sec
Standard Deviation 98.2
|
576.6 sec
Standard Deviation 157.3
|
562.2 sec
Standard Deviation 101.8
|
|
Cardiorespiratory Fitness
6 months
|
503.9 sec
Standard Deviation 80.8
|
528.2 sec
Standard Deviation 103.7
|
514.1 sec
Standard Deviation 73.1
|
|
Cardiorespiratory Fitness
12 months
|
487.7 sec
Standard Deviation 74.7
|
512.2 sec
Standard Deviation 96.5
|
500.5 sec
Standard Deviation 77.5
|
|
Cardiorespiratory Fitness
18 months
|
498.0 sec
Standard Deviation 80.9
|
518.4 sec
Standard Deviation 107.6
|
517.0 sec
Standard Deviation 103.7
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 months, 18 months, 24 months, 36 monthsMeasured in the clinical horizontally at the umbilicus.
Outcome measures
| Measure |
Standard Behavior Therapy for Weight Loss
n=110 Participants
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).
|
Behavior Therapy for Weight Loss With PA Emphasis
n=105 Participants
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).
|
Acceptance-based Behavior Therapy With PA Emphasis
n=105 Participants
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).
|
|---|---|---|---|
|
Waist Circumference
Baseline
|
42.6 cm
Standard Deviation 5.5
|
42.6 cm
Standard Deviation 4.7
|
41.8 cm
Standard Deviation 4.5
|
|
Waist Circumference
6 Months
|
39.0 cm
Standard Deviation 5.1
|
39.7 cm
Standard Deviation 4.8
|
38.9 cm
Standard Deviation 4.3
|
|
Waist Circumference
12 Months
|
38.6 cm
Standard Deviation 5.2
|
38.8 cm
Standard Deviation 4.9
|
38.2 cm
Standard Deviation 4.6
|
|
Waist Circumference
18 Months
|
39.2 cm
Standard Deviation 5.8
|
38.9 cm
Standard Deviation 5.3
|
38.5 cm
Standard Deviation 4.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 months, 6 monthsEmotional Overeating Questionnaire. The Emotional Overeating Questionnaire 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 6 emotions (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. Total scores range from 0-6 (units are scores on the scale). Higher total scores indicate more frequent emotional overeating (i.e., worse outcome). The Emotional Overeating Questionnaire has previously shown high internal consistency (alpha = 0.85) with test-retest reliability among individuals with Binge Eating Disorder (Masheb \& Grilo, 2006).
Outcome measures
| Measure |
Standard Behavior Therapy for Weight Loss
n=103 Participants
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).
|
Behavior Therapy for Weight Loss With PA Emphasis
n=98 Participants
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).
|
Acceptance-based Behavior Therapy With PA Emphasis
n=92 Participants
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).
|
|---|---|---|---|
|
Exploratory Moderator: Emotional Overeating
Baseline
|
0.62 units on a scale
Standard Deviation 0.83
|
0.58 units on a scale
Standard Deviation 0.65
|
0.81 units on a scale
Standard Deviation 0.86
|
|
Exploratory Moderator: Emotional Overeating
6 months
|
0.50 units on a scale
Standard Deviation 0.54
|
0.53 units on a scale
Standard Deviation 0.61
|
0.58 units on a scale
Standard Deviation 0.60
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 months, 6 monthsThe 18-item Three Factor Eating Questionnaire (TFEQ) (Cappelleri, Bushmakin, Gerber, Leidy, Sexton, Lowe, et al., 2009) assessed disinhibited eating behavior. The questionnaire consists of statements about food and participants rate if they 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 for disinhibited eating. This project used scoring from Niemeier, Phelan, Fava, \& Wing, 2007, responses are coded 0 (mostly/definitely false) or 1 (mostly/definitely true). Total scores range from 0-18 (higher scores mean more problematic eating behaviors, i.e., worse outcome). The disinhibited eating subscale is the sum of 16 items (range 0-16), such as: "Sometimes when I start eating, I just can't seem to stop." Higher scores indicate higher levels of disinhibited eating (i.e., worse outcome). Units are scores on the scale.
Outcome measures
| Measure |
Standard Behavior Therapy for Weight Loss
n=110 Participants
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).
|
Behavior Therapy for Weight Loss With PA Emphasis
n=101 Participants
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).
|
Acceptance-based Behavior Therapy With PA Emphasis
n=103 Participants
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).
|
|---|---|---|---|
|
Exploratory Moderator: Disinhibited Eating.
Baseline
|
8.50 units on a scale
Standard Deviation 3.08
|
8.89 units on a scale
Standard Deviation 3.38
|
9.40 units on a scale
Standard Deviation 3.61
|
|
Exploratory Moderator: Disinhibited Eating.
6 months
|
7.55 units on a scale
Standard Deviation 3.03
|
7.77 units on a scale
Standard Deviation 3.27
|
7.54 units on a scale
Standard Deviation 3.60
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 months, 6 monthsThe Power of Food Scale 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 with three subscales based on food proximity: (1) Food available in the environment but not physically present (sum of 6 items, range 6-30) (2) Food physically present but not yet tasted (sum of 4 items, range 4-20), and (3) Food tasted but not yet consumed (sum of 5 items, range 5-25). An example item is: "If I see or smell a food I like, I get a powerful urge to have some." Participants rated each of these statements on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Total scores are a sum of the 15 items (range 15-75) (units are scores on the scale). Higher total and subscale scores indicate greater hedonic hunger (i.e., worse outcome).
Outcome measures
| Measure |
Standard Behavior Therapy for Weight Loss
n=109 Participants
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).
|
Behavior Therapy for Weight Loss With PA Emphasis
n=101 Participants
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).
|
Acceptance-based Behavior Therapy With PA Emphasis
n=101 Participants
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).
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|---|---|---|---|
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Exploratory Moderator: Hedonic Hunger
Baseline
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40.00 units on a scale
Standard Deviation 13.18
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38.81 units on a scale
Standard Deviation 13.04
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42.65 units on a scale
Standard Deviation 13.83
|
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Exploratory Moderator: Hedonic Hunger
6 months
|
39.01 units on a scale
Standard Deviation 13.58
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37.14 units on a scale
Standard Deviation 13.11
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39.04 units on a scale
Standard Deviation 12.92
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OTHER_PRE_SPECIFIED outcome
Timeframe: 0 months, 6 monthsPopulation: Number of participants analyzed at 6 months may differ from that at baseline based on differential completion of measures by each participant at each timepoint.
Perceived Appetitive Response to Exercise. This was a single item measure, where participants were asked to select which one of these four options best 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 item was constructed by the research team, as no pre-existing measure of this construct was identified. The count and percent of participants within each category (by treatment condition) was calculated. This variable consists of four categorical responses, and thus does not have a minimum/maximum value. None of the response options are considered better or worse than the others. Each option describes separate potential experiences participants may have had in relation to eating/exercise over the past month.
Outcome measures
| Measure |
Standard Behavior Therapy for Weight Loss
n=93 Participants
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).
|
Behavior Therapy for Weight Loss With PA Emphasis
n=89 Participants
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).
|
Acceptance-based Behavior Therapy With PA Emphasis
n=84 Participants
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).
|
|---|---|---|---|
|
Exploratory Moderator: Appetitive Response to Exercise
Baseline · There is no relationship between my level of exercise and my appetite.
|
34 Participants
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32 Participants
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34 Participants
|
|
Exploratory Moderator: Appetitive Response to Exercise
Baseline · Not applicable (I have not exercised).
|
16 Participants
|
15 Participants
|
19 Participants
|
|
Exploratory Moderator: Appetitive Response to Exercise
Baseline · Exercise helps me control my appetite - I am less hungry when I am exercising regularly.
|
26 Participants
|
25 Participants
|
17 Participants
|
|
Exploratory Moderator: Appetitive Response to Exercise
Baseline · Exercise increases my appetite - I am more hungry when I am exercising regularly.
|
17 Participants
|
12 Participants
|
14 Participants
|
|
Exploratory Moderator: Appetitive Response to Exercise
6 Months · Not applicable (I have not exercised).
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Exploratory Moderator: Appetitive Response to Exercise
6 Months · There is no relationship between my level of exercise and my appetite.
|
35 Participants
|
30 Participants
|
32 Participants
|
|
Exploratory Moderator: Appetitive Response to Exercise
6 Months · Exercise helps me control my appetite - I am less hungry when I am exercising regularly.
|
34 Participants
|
37 Participants
|
31 Participants
|
|
Exploratory Moderator: Appetitive Response to Exercise
6 Months · Exercise increases my appetite - I am more hungry when I am exercising regularly.
|
22 Participants
|
19 Participants
|
17 Participants
|
Adverse Events
Standard Behavior Therapy for Weight Loss
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Behavior Therapy for Weight Loss With PA Emphasis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Acceptance-based Behavior Therapy With PA Emphasis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place