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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK103668 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Weight Loss (BWL) | Active Comparator | 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. |
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| BWL + Autonomous Motivation | Active Comparator | 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). |
|
| BWL + Extrinsic Motivation | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Weight Loss (BWL) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Loss | Primary pre-specified outcome is weight change in kilograms from baseline to 6 months. Change in kg was used in power calculations. | 6 Months |
| Percent Weight Loss | Pre-specified analyses to examine impact on weight include percent weight loss from baseline to 6 months | 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. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Waist Circumference | Change in waist circumference (in cm) from baseline to 6 months. | 6 Months |
| Body Composition (percent fat mass) | Change in fat mass from baseline to 6 months, measured by bioelectrical impedance analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 Months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica G LaRose, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University, School of Medicine | Richmond | Virginia | 232398 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36121656 | Derived | LaRose JG, Leahey TM, Lanoye A, Bean MK, Fava JL, Tate DF, Evans RK, Wickham EP 3rd, Henderson MM. Effect of a Lifestyle Intervention on Cardiometabolic Health Among Emerging Adults: A Randomized Clinical Trial. JAMA Netw Open. 2022 Sep 1;5(9):e2231903. doi: 10.1001/jamanetworkopen.2022.31903. | |
| 34044124 | Derived | LaRose JG, Leahey TM, Lanoye A, Bean MK, Tate DF, Fava JL, Evans RK, Wickham E 3rd, Henderson MM, Hatley K, Diamond M. Behavioral weight loss in emerging adults: Design and rationale for the Richmond Emerging Adults Choosing Health (REACH) randomized clinical trial. Contemp Clin Trials. 2021 Aug;107:106426. doi: 10.1016/j.cct.2021.106426. Epub 2021 May 24. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 1, 2018 | Jun 5, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
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| BWL + Autonomous Motivation | Behavioral | 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). |
|
| BWL + Extrinsic Motivation | Behavioral | 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. |
|
| 6 Months |
| Blood Pressure | Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to 6 months. | 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). | 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. | 6 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. |
| 12 Months |
| 33782906 | Derived | Brown KL, Hines AL, Hagiwara N, Utsey S, Perera RA, LaRose JG. The Weight of Racial Discrimination: Examining the Association Between Racial Discrimination and Change in Adiposity Among Emerging Adult Women Enrolled in a Behavioral Weight Loss Program. J Racial Ethn Health Disparities. 2022 Jun;9(3):909-920. doi: 10.1007/s40615-021-01030-7. Epub 2021 Mar 29. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |