ObesityREACHNCT02736981
Low Intensity Weight Loss for Young Adults
A study testing Behavioral Weight Loss (BWL), BWL + Autonomous Motivation and BWL + Extrinsic Motivation in people with Obesity, run by Virginia Commonwealth University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Behavioral Weight Loss (BWL), BWL + Autonomous Motivation and BWL + Extrinsic Motivation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 8 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University, School of Medicine
Richmond, Virginia, 232398
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Behavioral Weight Loss (BWL), BWL + Autonomous Motivation, BWL + Extrinsic Motivation
- Keywords
- Obesity, Weight Loss, Young Adults
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Weight Loss (BWL)Behavioural
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.
BWL + Autonomous MotivationBehavioural
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 MotivationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Behavioral Weight Loss (BWL) |
| 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). Receives: Behavioral: Behavioral Weight Loss (BWL); Behavioral: BWL + Autonomous Motivation |
| 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. Receives: Behavioral: Behavioral Weight Loss (BWL); Behavioral: BWL + Extrinsic Motivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
Primary pre-specified outcome is weight change in kilograms from baseline to 6 months. Change in kg was used in power calculations.
Measured: 6 Months
Percent Weight Loss
Pre-specified analyses to examine impact on weight include percent weight loss from baseline to 6 months
Measured: 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.
Measured: 6 Months
Secondary outcomes (5)
Waist Circumference
Change in waist circumference (in cm) from baseline to 6 months.
Measured: 6 Months
Body Composition (percent fat mass)
Change in fat mass from baseline to 6 months, measured by bioelectrical impedance analysis.
Measured: 6 Months
Blood Pressure
Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to 6 months.
Measured: 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).
Measured: 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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startJan 2016
- Primary completion27 Aug 2019
- Study completion8 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica G LaRose, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736981
- Sponsor's protocol ID
- HM20002772
- Other IDs
- R01DK103668
- Acronym
- REACH
- Status last verified
- Jun 2023
- First submitted
- 18 Feb 2016
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36121656LaRose 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.
PubMed 34044124Brown 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.
PubMed 33782906
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Intensity Weight Loss for Young Adults
- ClinicalTrials.gov ID
- NCT02736981
- Acronym / sponsor ID
- REACH / HM20002772
- Conditions
- Obesity
- Keywords
- Obesity, Weight Loss, Young Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2016 (actual)
- Primary completion
- 27 Aug 2019 (actual)
- Study completion
- 8 Feb 2020 (actual)
- First posted
- 13 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Behavioral Weight Loss (BWL) | Active comparator | 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. |
| BWL + Autonomous Motivation | Active comparator | Behavioral: Behavioral Weight Loss (BWL), Behavioral: BWL + Autonomous Motivation24 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 | Behavioral: Behavioral Weight Loss (BWL), Behavioral: BWL + Extrinsic Motivation24 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Weight Loss (BWL)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. | Behavioural | BWL + Autonomous Motivation, BWL + Extrinsic Motivation, Behavioral Weight Loss (BWL) |
| BWL + Autonomous MotivationThe 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). | Behavioural | BWL + Autonomous Motivation |
| BWL + Extrinsic MotivationThe 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. | Behavioural | BWL + Extrinsic Motivation |
Primary outcome
Weight Loss
Time frame: 6 Months
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
Time frame: 6 Months
Pre-specified analyses to examine impact on weight include percent weight loss from baseline to 6 months
Change in Body Mass Index
Time frame: 6 Months
Change in body mass index (calculated as change in kg/m^2, weight in kilograms, height in meters) from baseline to 6 months.
5 secondary outcomes
Waist Circumference
Time frame: 6 Months
Body Composition (percent fat mass)
Time frame: 6 Months
Blood Pressure
Time frame: 6 Months
Minutes of Moderate to Vigorous Physical Activity
Time frame: 6 Months
Dietary Intake
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Derived from this study: PubMed 36121656LaRose 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.
- Derived from this study: PubMed 34044124LaRose 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.
- Derived from this study: PubMed 33782906Brown 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica G LaRose, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Weight Loss (BWL), BWL + Autonomous Motivation and BWL + Extrinsic Motivation in people with Obesity, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Loss (time frame: 6 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02736981, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.