Optimizing an Extended Care Intervention to Promote Weight Loss Maintenance

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06785064
Status
Recruiting
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Conditions

  • Obesity Prevention
  • Weight Change
  • Weight Loss
  • Weight Loss Maintenance

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Reduced Food Variety (RFV) — BEHAVIORAL
    Participants engaged in reduced food variety (RFV) will be asked to choose a few high-calorie, low nutrient main meals and snacks to eat regularly. At the beginning of each month, they will choose one main meal (entrée) to eat at least 2 times a week and one snack food to eat at least 4 times a week within the month. They will have the option to keep or change their main meal and snack options from month to month.
  • Home-based Resistance Training (HBRT) — BEHAVIORAL
    Participants assigned to receive home-based resistance training (also called strength training or lifting weights) will be asked to engage in at-home exercises that strengthen muscles at least 2 days each week (≤45 minutes per home session) and track their progress. They will be asked to attend 6, 1-hour group-based skills training workshops (in-person and/or remotely via Zoom) during the first two months of Phase 2 to learn these skills. They will receive exercise plans and equipment (sets of dumbbells, a rack to hold the dumbbells, and an exercise mat) needed to complete exercises.
  • Buddy Training and Support (BTS) — BEHAVIORAL
    Participants assigned to buddy training and support will be asked to identify an eligible friend or family member who is over 18 years old that can be their "buddy". Study staff will contact the buddy to be sure they are eligible, willing, and have all the details they need. The participant's buddy will be asked to attend up to 6 training sessions with the study staff, so they can learn the best ways to support the participant during the program. After the buddy completes training, they will be asked to check in with the participant 1-2 times each week about their progress.
  • Acceptance and Commitment (ACT) Workshops — BEHAVIORAL
    Participants assigned to receive Acceptance and Commitment (ACT) Workshops will be asked to attend 6, 1-hour group-based skills training workshops (in-person and/or remotely via Zoom) during the first three months of Phase 2. These workshops will help them develop skills to handle tough thoughts about weight control, keep their values in mind, and be mindful of their decisions and the impact of their decisions related to weight control. They will also be asked to apply ACT skills regularly during the rest of Phase 2.

Study Details

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.

Key Dates

Start date
Dec 2, 2025
Status verified
Jan 2026
Primary completion
Nov 30, 2028
Completion
Feb 28, 2029

Study Design

Enrollment
544 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change in weight from time of randomization to 12 months [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35205
Gareth Dutton, PhD
[email protected]
205-934-6876
Amy Dobelstein
[email protected]
205-975-1059

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