Scalable Behavioral Program for Weight Loss Maintenance After GLP-1 and Anti-Obesity Medication Discontinuation

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07535892
Status
Not Yet Recruiting

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Conditions

  • GLP - 1
  • Obesity & Overweight
  • Weight Loss
  • Weight Loss Maintenance

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Weight Loss Maintenance Program (Foundational) — BEHAVIORAL
    All participants will receive a standardized 10-week foundational weight loss maintenance program designed to address three key domains: food, physical activity, and mind-based practices. This foundational program is intended to support the transition from active weight loss to long-term weight maintenance.
  • Mom's Meals — BEHAVIORAL
    Medically tailored meals
  • YMCA Membership — BEHAVIORAL
    YMCA membership to support physical activity
  • SKY Meditation Program — BEHAVIORAL
    The SKY Meditation program to support mind-based practices

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Nov 30, 2028
Completion
Feb 28, 2029

Study Design

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

Arms

  • Active Comparator: Group 1: WLM Program + Mom's Meals + YMCA + SKY
    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.
  • Active Comparator: Group 2: WLM Program + Mom's Meals + YMCA
    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.
  • Active Comparator: Group 3: WLM Program + Mom's Meals + SKY
    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.
  • Active Comparator: Group 4: WLM Program + 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: (1) medically tailored meals (Mom's Meals).
  • Active Comparator: Group 5: WLM Program + YMCA + SKY
    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.
  • Active Comparator: Group 6: WLM Program + YMCA
    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.
  • Active Comparator: Group 7: WLM Program + SKY
    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.
  • Active Comparator: Group 8: Foundational WLM Program Only
    Eight participants will receive the 10-week foundational program. One group (n=8) will receive only the foundational program without any additional components.

Primary Outcome Measure

Percentage of participants retention [ Time Frame: 3 months, 6 months, ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Holly Wyatt, MD
[email protected]
205-975-6270
Holly Wyatt, MD (PRINCIPAL_INVESTIGATOR)

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