An interventional study of Behavioral Weight Loss (BWL) and BWL + Autonomous Motivation in Obesity, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-07.
Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Treatment
This is a 3-arm randomized controlled trial to test the efficacy of three novel motivational approaches to weight loss with 18-25 year olds. Participants will be 18-25 year olds with a BMI of 25-45 kg/m2, randomized to: 1) Behavioral Weight Loss (BWL), 2) BWL + Autonomous Motivation (BWL+Aut) or 3) BWL + Extrinsic Motivation (BWL+Ext). All arms will receive a 6-month behavioral weight loss intervention, followed by a 6-month no-treatment follow up period.
A 3-arm randomized controlled trial will be conducted, the goal of which is to determine which group represents the most viable approach to behavioral weight loss treatment with 18-25 year olds. A total of 381 participants,18-25 years of age, with a BMI between 25 and 45 kg/m2 will be randomized to one of three groups: 1) Behavioral Weight Loss (BWL), 2) BWL + Autonomous Motivation (BWL+Aut) or 3) BWL + Extrinsic Motivation (BWL+Ext). All arms will receive a 24-week behavioral weight loss intervention, including personalized dietary, physical activity, and weight loss prescriptions. In addition, all arms will be followed for a 6 month no treatment follow-up period. Assessments of weight and secondary outcomes will occur in 0, 3, 6 and 12 months. The investigators will compare treatment effects, across all 3 arms at 6 months, and compare arms on weight loss maintenance at12 months. The investigators will also examine mediators of treatment outcomes consistent with the investigators theoretical framework.
1,766 studies on the registry are indexed under Weight Loss; 278 are open to participants now.
This study's enrollment of 382 is above the median of 73 across 1,496 interventional studies indexed under Weight Loss.
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Exclusion Criteria:
24 week treatment program consisting of a single, 90-minute, in-person group session in week 1, and a single 45 minute individual in-person session in week two, followed by a 6 month technology mediated program. The program includes evidenced-based behavioral weight loss content, individualized diet and physical activity goals, weekly lessons as well as reporting of key behaviors and personalized feedback to aid in goal attainment.
Behavioral: Behavioral Weight Loss (BWL)
24 week treatment program consisting of a single, 90-minute, in-person group session in week 1, and a single 45 minute individual in-person session in week two, followed by a 6 month technology mediated program. The program includes evidenced-based behavioral weight loss content, individualized diet and physical activity goals, weekly lessons as well as reporting of key behaviors and personalized feedback to aid in goal attainment. Participants in this arm will receive coaching that places an increased emphasis on their values and personal choices, and also have the option to attend several experiential group sessions that will help those interested to apply the material and skills they are being taught (e.g., cooking demonstration, circuit training class).
Behavioral: Behavioral Weight Loss (BWL) · Behavioral: BWL + Autonomous Motivation
24 week treatment program consisting of a single, 90-minute, in-person group session in week 1, and a single 45 minute individual in-person session in week two, followed by a 6 month technology mediated program. The program includes evidenced-based behavioral weight loss content, individualized diet and physical activity goals, weekly lessons as well as reporting of key behaviors and personalized feedback to aid in goal attainment. Participants in this arm will have the opportunity to receive small monetary incentives in weeks 2-24 for tracking weight and calorie intake, and will be eligible for a raffle based on weight loss.
Behavioral: Behavioral Weight Loss (BWL) · Behavioral: BWL + Extrinsic Motivation
The intervention represents an adapted version of gold-standard evidence based adult behavioral weight loss that has been tailored specifically to meet the needs of 18-25 year olds. The program includes personalized dietary and physical activity prescriptions, training in behavioral strategies, weekly lesson content, and reporting of key behaviors and personalized feedback and coaching.
The intervention represents an adapted version of gold-standard evidence based adult behavioral weight loss that has been tailored specifically to meet the needs of 18-25 year olds. The program includes personalized dietary and physical activity prescriptions, training in behavioral strategies, weekly lesson content, and reporting of key behaviors and personalized feedback and coaching. Participants in this arm will receive coaching that places an increased emphasis on their values and personal choices, and also have the option to attend several experiential group sessions that will help those interested to apply the material and skills they are being taught (e.g., cooking demonstration, circuit training class).
The intervention represents an adapted version of gold-standard evidence based adult behavioral weight loss that has been tailored specifically to meet the needs of 18-25 year olds. The program includes personalized dietary and physical activity prescriptions, training in behavioral strategies, weekly lesson content, and reporting of key behaviors and personalized feedback and coaching. Participants in this arm will have the opportunity to receive small monetary incentives in weeks 2-24 for tracking weight and calorie intake, and will be eligible for a raffle based on weight loss.
Weight Loss
Primary pre-specified outcome is weight change in kilograms from baseline to 6 months. Change in kg was used in power calculations.
Time frame: 6 Months
Percent Weight Loss
Pre-specified analyses to examine impact on weight include percent weight loss from baseline to 6 months
Time frame: 6 Months
Change in Body Mass Index
Change in body mass index (calculated as change in kg/m\^2, weight in kilograms, height in meters) from baseline to 6 months.
Time frame: 6 Months
Waist Circumference
Change in waist circumference (in cm) from baseline to 6 months.
Time frame: 6 Months
Body Composition (percent fat mass)
Change in fat mass from baseline to 6 months, measured by bioelectrical impedance analysis.
Time frame: 6 Months
Blood Pressure
Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to 6 months.
Time frame: 6 Months
Minutes of Moderate to Vigorous Physical Activity
Change in minutes of moderate-to-vigorous activity from baseline to 6 months as assessed by objective activity monitors (Actigraph).
Time frame: 6 Months
Dietary Intake
Change in fat intake, sugared beverage intake, alcohol intake, fruit and vegetable intake from baseline to 6 months as assessed by interviewer administered modules.
Time frame: 6 Months
Weight Loss Maintenance
Pre-specified analyses to examine overall weight loss maintenance include weight change in kilograms from baseline to 12 months and change in percent weight loss from baseline to 12 months. Please note that both indices were included in the same secondary aim for funding agency and approved.
Time frame: 12 Months
Long-term Change in Body Mass Index
Overall change in body mass index (calculated as change in kg/m\^2) from baseline to 12 months.
Time frame: 12 Months
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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Virginia Commonwealth University