Scalable Behavioral Program for Weight Loss Maintenance After GLP-1 and Anti-Obesity Medication Discontinuation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Weight Loss Maintenance Program (Foundational), Mom's Meals, YMCA Membership, SKY Meditation Program.
- Who it may be relevant to
- Registry conditions: Weight Loss, GLP - 1, Weight Loss Maintenance, Obesity & Overweight. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pilot Trial of a Scalable Behavioral Program for Weight Loss Maintenance After GLP-1 and Anti-Obesity Medication Discontinuation
Overview
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.
Interventions
- Behavioral Weight Loss Maintenance Program (Foundational)
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. - Behavioral Mom's Meals
Medically tailored meals - Behavioral YMCA Membership
YMCA membership to support physical activity - Behavioral SKY Meditation Program
The SKY Meditation program to support mind-based practices
Primary outcome measures
- Percentage of participants retention [Time frame: 3 months, 6 months,]
- Percentage of participants that adhered to the 10-week foundational support sessions [Time frame: 10 weeks]
Secondary outcome measures (1)
- Overall Weight Loss Maintenance without medication [Time frame: Baseline, 3 months, 6 moths]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Alabama at Birmingham — Birmingham
Identifiers
NCT: NCT07535892 · IRB-300016552 · 1R01DK147319-01