Behavioral Program for Weight Loss Maintenance
What You Need to Know Before You Apply
What is the purpose of this trial?
This study is a single-site, pilot randomized factorial trial designed to evaluate the feasibility, acceptability, participant perceptions and preliminary effects of a multi-component behavioral intervention to support weight loss maintenance following discontinuation of GLP-1 and other anti-obesity medications. The intervention includes a standardized 10-week foundational weight loss maintenance program combined with candidate support components, including medically tailored meals, YMCA membership, and a structured mind-based program. Participants will be randomized using a 2 × 2 × 2 factorial design and followed for six months. Findings from this pilot study will inform optimization of a scalable intervention for future clinical trials.
Who Is on the Research Team?
Holly Wyatt, MD
Principal Investigator
University of Alabama at Birmingham
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a 10-week foundational weight loss maintenance program with various support components
Follow-up
Participants are monitored for retention and adherence, with assessments at 3 and 6 months
What Are the Treatments Tested in This Trial?
Interventions
- Mom's Meals
- SKY Meditation Program
- Weight Loss Maintenance Program (Foundational)
- YMCA Membership
How Is the Trial Designed?
8
Treatment groups
Active Control
Eight participants will be assigned to the foundational WLM program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive three candidate support components: (1) medically tailored meals (Mom's Meals), (2) YMCA membership to support physical activity, and (3) the SKY Meditation program to support mind-based practices.
Eight Participants will be assigned to the foundational program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive two candidate support components: (1) medically tailored meals (Mom's Meals), (2) YMCA membership to support physical activity.
Eight Participants will be assigned to the foundational program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive candidate support components: (1) medically tailored meals (Mom's Meals), and (3) the SKY Meditation program to support mind-based practices.
Eight Participants will be assigned to the foundational program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive candidate support components: (1) medically tailored meals (Mom's Meals).
Eight Participants will be assigned to the foundational program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive candidate support components: (2) YMCA membership to support physical activity, and (3) the SKY Meditation program to support mind-based practices.
Eight Participants will be assigned to the foundational program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive support components: (2) YMCA membership to support physical activity.
Eight Participants will be assigned to the foundational program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive support components: (3) the SKY Meditation program to support mind-based practices.
Eight participants will receive the 10-week foundational program. One group (n=8) will receive only the foundational program without any additional components.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
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