Scalable Behavioral Program for Weight Loss Maintenance After GLP-1 and Anti-Obesity Medication Discontinuation
Pilot Trial of a Scalable Behavioral Program for Weight Loss Maintenance After GLP-1 and Anti-Obesity Medication Discontinuation
2 other identifiers
interventional
64
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2026
CompletedFirst Posted
Study publicly available on registry
April 17, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2028
Study Completion
Last participant's last visit for all outcomes
February 28, 2029
April 17, 2026
April 1, 2026
2.5 years
April 10, 2026
April 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of participants retention
Retention will be calculated as the proportion of randomized participants completing the 3- and 6-month follow-up assessments. For the proposed study, retention rates ≥80% over the 6-month intervention period would indicate the study is feasible as-is. If retention is \<80%, we will consider modifications to the study design and dedication of greater resources towards improving retention in the full-scale factorial trial.
3 months, 6 months,
Percentage of participants that adhered to the 10-week foundational support sessions
Adherence to the 10-week foundational support sessions will be measured as the percentage of attended sessions relative to scheduled sessions. For the proposed study, the feasibility benchmark for adherence was set at ≥80% attendance. If adherence is \<80%, we will consider modifications to the study design and dedication of greater resources towards improving adherence in the full-scale factorial trial. The other measures of adherence will be evaluated with descriptive statistics. Completion rates of weekly logs for food intake, physical activity, and mind-based practices will be documented and tracked in REDCap. Additionally, daily usage of Garmin scales and fitness trackers will be monitored, with rates of adherence assessed as the percentage of days that participants engage with these devices.
10 weeks
Secondary Outcomes (1)
Overall Weight Loss Maintenance without medication
Baseline, 3 months, 6 moths
Study Arms (8)
Group 1: WLM Program + Mom's Meals + YMCA + SKY
ACTIVE COMPARATOREight 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.
Group 2: WLM Program + Mom's Meals + YMCA
ACTIVE COMPARATOREight 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.
Group 3: WLM Program + Mom's Meals + SKY
ACTIVE COMPARATOREight 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.
Group 4: WLM Program + Mom's Meals
ACTIVE COMPARATOREight 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).
Group 5: WLM Program + YMCA + SKY
ACTIVE COMPARATOREight 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.
Group 6: WLM Program + YMCA
ACTIVE COMPARATOREight 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.
Group 7: WLM Program + SKY
ACTIVE COMPARATOREight 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.
Group 8: Foundational WLM Program Only
ACTIVE COMPARATOREight participants will receive the 10-week foundational program. One group (n=8) will receive only the foundational program without any additional components.
Interventions
YMCA membership to support physical activity
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.
Medically tailored meals
The SKY Meditation program to support mind-based practices
Eligibility Criteria
You may qualify if:
- Age 18 years or older
- Loss of ≥15% of initial body weight using anti-obesity medication
- Discontinued anti-obesity medication within the past 4 weeks or planning to discontinue prior to randomization
- ≤3 kg weight regain within the past 3 months
- Willing and able to participate in a 6-month behavioral intervention, including a 10-week foundational program
- Willing to complete study assessments at baseline, 3 months, and 6 months, including required in-person visits
- Medical clearance for participation in moderate physical activity, dietary modification, and mind-based practices
- Access to reliable internet for participation in virtual sessions and remote data collection
- English fluency sufficient to complete study procedures
- Able to provide informed consent
You may not qualify if:
- Medical conditions that would preclude safe participation in physical activity, dietary changes, or mind-based practices (e.g., unstable cardiovascular disease, uncontrolled hypertension, severe orthopedic limitations, or seizure disorders not medically managed)
- Active psychiatric conditions that would interfere with participation or safety (e.g., untreated major depression, active substance use disorder, or psychosis)
- Pregnancy, breastfeeding, or plans to become pregnant during the study period
- Current participation in another structured weight loss or weight maintenance program
- Continued use of anti-obesity medication after randomization
- Plans to initiate medications or treatments that may significantly affect body weight during the study period
- Inability to attend required study visits or participate in virtual sessions and remote data collection
- Any condition that, in the opinion of the investigators, would compromise participant safety or study integrity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Holly Wyatt, MD
University of Alabama at Birmingham
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 10, 2026
First Posted
April 17, 2026
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
November 30, 2028
Study Completion (Estimated)
February 28, 2029
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- IPD and supporting information will be available at the time of publication of manuscripts associated with this trial.
- Access Criteria
- Freely available for download from PubMed central as supplemental materials to associated manuscripts
At the time of publication(s) related to this trial, a fully de-identified dataset including participant data will be made available so that data analysis can be replicated by other investigators. This dataset will be freely available for download as supplemental materials to manuscripts(s) submitted to PubMed Central.