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.
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
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
Factorial
Weight Loss Maintenance Program (Foundational)
BehavioralAll 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
BehavioralMedically tailored meals
YMCA Membership
BehavioralYMCA membership to support physical activity
SKY Meditation Program
BehavioralThe SKY Meditation program to support mind-based practices
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Treatment groupsSee each treatment group below.
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.
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.
Overall Weight Loss Maintenance without medication
Participants will be weighed at Baseline, 3 month, and 6 month intervals to see if they have maintained their overall weight loss.
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University of Alabama at Birmingham
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
