Back to resultsLow Intensity Weight Loss for Young Adults (REACH)
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Weight Loss (BWL)
BWL + Autonomous Motivation
BWL + Extrinsic Motivation
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Weight Loss, Young Adults
Eligibility Criteria
Inclusion Criteria:
- Between 18-25 years of age. Body Mass Index (BMI) between 25 and 45 kg/m2. Men and women will be recruited. All race and ethnic groups will be recruited.
Exclusion Criteria:
- Report an uncontrolled medical condition that may pose a safety issue given the recommendations for diet and unsupervised physical activity in the current study (e.g., uncontrolled hypertension). The investigators will refer individuals who have blood pressure levels >140 / 90 mmHg as part of baseline screening to their physician and exclude them from this study unless their treating physician determines s/he is a suitable candidate based on the specifics of the protocol and provides written medical consent for participation. Participants who report a history of or current treatment for medical conditions (e.g., hypertension, diabetes) will be asked to obtain MD consent to participate.
- Other health problems or medications which may influence the ability to walk for physical activity or be associated with unintentional weight change, including cancer treatment within the past 5 years or tuberculosis.
- Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q), which will be administered during prescreen. Individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
- Report a history of, or current diagnosis of anorexia nervosa or bulimia nervosa, or any current compensatory behaviors (e.g., vomiting, laxative use, excessive exercise).
- Current symptoms of alcohol or substance dependence.
- Planning to move from the area within the study period.
- Currently pregnant, pregnant within the past 6 months, currently breastfeeding or planning to become pregnant within the next 12 months.
- Hospitalization for depression or other psychiatric disorder within the past 12 months. History of psychotic disorder or bipolar disorder.
- Another member of the household is a participant or staff member on this study.
- Participation in another research study that may interfere with this study.
- Currently participating in a weight loss program and/or taking weight loss medication or lost > 5% of body weight during the past 3 months.
- Failure to complete the screening appointments.
Sites / Locations
- Virginia Commonwealth University, School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Behavioral Weight Loss (BWL)
BWL + Autonomous Motivation
BWL + Extrinsic Motivation
Arm Description
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.
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).
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.
Outcomes
Primary Outcome Measures
Weight Loss
Primary pre-specified outcome is weight change in kilograms from baseline to 6 months. Change in kg was used in power calculations.
Percent Weight Loss
Pre-specified analyses to examine impact on weight include percent weight loss from baseline to 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.
Secondary Outcome Measures
Waist Circumference
Change in waist circumference (in cm) from baseline to 6 months.
Body Composition (percent fat mass)
Change in fat mass from baseline to 6 months, measured by bioelectrical impedance analysis.
Blood Pressure
Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to 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).
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.
Full Information
NCT ID
NCT02736981
First Posted
February 18, 2016
Last Updated
June 5, 2023
Sponsor
Virginia Commonwealth University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT02736981
Brief Title
Low Intensity Weight Loss for Young Adults
Acronym
REACH
Official Title
Low Intensity Weight Loss for Young Adults
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
August 27, 2019 (Actual)
Study Completion Date
February 8, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Weight Loss, Young Adults
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
382 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behavioral Weight Loss (BWL)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
BWL + Autonomous Motivation
Arm Type
Active Comparator
Arm Description
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).
Arm Title
BWL + Extrinsic Motivation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Weight Loss (BWL)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
BWL + Autonomous Motivation
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
BWL + Extrinsic Motivation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight Loss
Description
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
Title
Percent Weight Loss
Description
Pre-specified analyses to examine impact on weight include percent weight loss from baseline to 6 months
Time Frame
6 Months
Title
Change in Body Mass Index
Description
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
Secondary Outcome Measure Information:
Title
Waist Circumference
Description
Change in waist circumference (in cm) from baseline to 6 months.
Time Frame
6 Months
Title
Body Composition (percent fat mass)
Description
Change in fat mass from baseline to 6 months, measured by bioelectrical impedance analysis.
Time Frame
6 Months
Title
Blood Pressure
Description
Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to 6 months.
Time Frame
6 Months
Title
Minutes of Moderate to Vigorous Physical Activity
Description
Change in minutes of moderate-to-vigorous activity from baseline to 6 months as assessed by objective activity monitors (Actigraph).
Time Frame
6 Months
Title
Dietary Intake
Description
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
Other Pre-specified Outcome Measures:
Title
Weight Loss Maintenance
Description
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
Title
Long-term Change in Body Mass Index
Description
Overall change in body mass index (calculated as change in kg/m^2) from baseline to 12 months.
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Between 18-25 years of age. Body Mass Index (BMI) between 25 and 45 kg/m2. Men and women will be recruited. All race and ethnic groups will be recruited.
Exclusion Criteria:
Report an uncontrolled medical condition that may pose a safety issue given the recommendations for diet and unsupervised physical activity in the current study (e.g., uncontrolled hypertension). The investigators will refer individuals who have blood pressure levels >140 / 90 mmHg as part of baseline screening to their physician and exclude them from this study unless their treating physician determines s/he is a suitable candidate based on the specifics of the protocol and provides written medical consent for participation. Participants who report a history of or current treatment for medical conditions (e.g., hypertension, diabetes) will be asked to obtain MD consent to participate.
Other health problems or medications which may influence the ability to walk for physical activity or be associated with unintentional weight change, including cancer treatment within the past 5 years or tuberculosis.
Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q), which will be administered during prescreen. Individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
Report a history of, or current diagnosis of anorexia nervosa or bulimia nervosa, or any current compensatory behaviors (e.g., vomiting, laxative use, excessive exercise).
Current symptoms of alcohol or substance dependence.
Planning to move from the area within the study period.
Currently pregnant, pregnant within the past 6 months, currently breastfeeding or planning to become pregnant within the next 12 months.
Hospitalization for depression or other psychiatric disorder within the past 12 months. History of psychotic disorder or bipolar disorder.
Another member of the household is a participant or staff member on this study.
Participation in another research study that may interfere with this study.
Currently participating in a weight loss program and/or taking weight loss medication or lost > 5% of body weight during the past 3 months.
Failure to complete the screening appointments.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica G LaRose, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University, School of Medicine
City
Richmond
State/Province
Virginia
ZIP/Postal Code
232398
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36121656
Citation
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.
Results Reference
derived
PubMed Identifier
34044124
Citation
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.
Results Reference
derived
PubMed Identifier
33782906
Citation
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.
Results Reference
derived
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Low Intensity Weight Loss for Young Adults
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