Low Intensity Weight Loss for Young Adults

Obesity Clinical Trial

— REACH  

Official title:

Low Intensity Weight Loss for Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02736981
• Other study ID #: HM20002772
• Secondary ID: R01DK103668
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: February 8, 2020

Study information

• Verified date: June 2023
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 Motivation (BWL+Ext). All arms will receive a 6-month behavioral weight loss intervention, followed by a 6-month no-treatment follow up period.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 382
• Est. completion date: February 8, 2020
• Est. primary completion date: August 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• 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.
• BWL + Autonomous 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. 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
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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University, School of Medicine	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	Percent Weight Loss	Pre-specified analyses to examine impact on weight include percent weight loss from baseline to 6 months	6 Months
Primary	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
Secondary	Waist Circumference	Change in waist circumference (in cm) from baseline to 6 months.	6 Months
Secondary	Body Composition (percent fat mass)	Change in fat mass from baseline to 6 months, measured by bioelectrical impedance analysis.	6 Months
Secondary	Blood Pressure	Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to 6 months.	6 Months
Secondary	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
Secondary	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