OPT-X: OPTimizing an EXtended Care Intervention to Promote Weight Loss Maintenance

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to find out what combination of components, if any, offers the best support for keeping weight off after someone loses weight. Long term weight loss maintenance is a challenge for many people who lose weight. There are many strategies, or components, people may use to avoid regain, but investigators do not know if there is a best, or optimal, combination of such components that can be done without adding a lot of cost or other burdens for people. * The primary goal of this clinical trial is to identify the optimal package that maximizes weight loss maintenance. * The study also wants to understand the reasons why these components may work and if certain components help specific sub-groups of people. Participants will engage in a 16-week Phase 1 Weight Loss Program. Participants who lose 5% or more of their weight during that program will continue to Phase 2 Extended Care and be randomly assigned to 0, 1, 2, 3, or all of four methods of weight loss maintenance. They will use their assigned package for 12 months. Researchers will compare 16 different possible combinations of components and learn which of the 16 packages offers the best support for keeping weight off. The four components participants could be assigned to in Phase 2 are: 1. Reduced Food Variety: Limiting the variety of foods participants eat by having them choose a few high-calorie, low nutrient foods to eat regularly 2. Home-based Resistance Training: Engaging in exercises that build strength from the comfort of the participant's own home 3. Buddy Training and Support: Having a friend or buddy get trained to support the participant 4. Acceptance and Commitment (ACT) Workshops: Having participants learn skills to handle tough thoughts and feelings about weight control in a healthy way Participants will have their weight measured and complete surveys 4 times if they complete both Phase 1 and Phase 2. During Phase 1, participants will attend weekly group sessions and be in touch with a study staff member investigators call a Wellness Coach. During Phase 2, participants will stay in touch with their Wellness Coach, use their assigned package, and answer questions about their experience periodically.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Age \>18 years

• Body mass index (BMI) \>30 kg/m2

• Has regular access to internet (to access Zoom videoconferencing platform)

• If indicated during screening, willing to obtain medical clearance for exercise from their healthcare provider prior to enrollment

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Contact Information
Primary
Gareth Dutton
gdutton@uabmc.edu
205-934-6876
Backup
Amy Dobelstein
adobelst@uabmc.edu
205-975-1059
Time Frame
Start Date: 2025-05-28
Estimated Completion Date: 2029-02-28
Participants
Target number of participants: 544
Treatments
No_intervention: Package 1: No WLM Components
Participants will receive education and support for weight loss maintenance only.
Active_comparator: Package 2: One WLM Component - BTS
Participants will receive education and support for weight loss maintenance and Buddy Training and Support.
Active_comparator: Package 3: One WLM Component - HBRT
Participants will receive education and support for weight loss maintenance and Home-based Resistance Training
Active_comparator: Package 4: Two WLM Components - HBRT+BTS
Participants will receive education and support for weight loss maintenance as well as Home-based Resistance Training and Buddy Training and Support.
Active_comparator: Package 5: One WLM Component - ACT
Participants will receive education and support for weight loss maintenance as well as Acceptance and Commitment (ACT) Workshops.
Active_comparator: Package 6: Two WLM Components - BTS+ACT
Participants will receive education and support for weight loss maintenance as well as Buddy Training and Support and ACT Workshops.
Active_comparator: Package 7: Two WLM Components - HBRT+ACT
Participants will receive education and support for weight loss maintenance as well as Home-based Resistance Training and ACT Workshops.
Active_comparator: Package 8: Three WLM Components - HBRT+BTS+ACT
Participants will receive education and support for weight loss maintenance as well as Home-based Resistance Training, Buddy Training and Support, and ACT Workshops.
Active_comparator: Package 9: One WLM Component - RFV
Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety.
Active_comparator: Package 10: Two WLM Components - RFV+BTS
Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety and Buddy Training and Support
Active_comparator: Package 11: Two WLM Components - RFV+HBRT
Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety and Home-based Resistance Training.
Active_comparator: Package 12: Three WLM Components - RFV+HBRT+BTS
Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety, Home-based Resistance Training, and Buddy Training and Support.
Active_comparator: Package 13: Two WLM Components - RFV+ACT
Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety and ACT Workshops.
Active_comparator: Package 14: Three WLM Components - RFV+BTS+ACT
Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety, Buddy Training and Support, and ACT Workshops.
Active_comparator: Package 15: Three WLM Components - RFV+HBRT+ACT
Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety, Home-based Resistance Training, and ACT Workshops.
Experimental: Package 16: Four WLM Components: RFV+HBRT+BTS+ACT
Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety, Home-based Resistance Training, Buddy Training and Support, and ACT Workshops.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov

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