Behavioral Program for Weight Loss Maintenance After GLP-1 and Anti-Obesity Medication Discontinuation
This study is looking for people who have lost a significant amount of weight using GLP-1 or other anti-obesity medications and have recently stopped or plan to stop taking them. The goal is to test different behavioral programs to help you maintain your weight loss. These programs include a 10-week foundational program focusing on food, exercise, and mind-based practices, potentially combined with medically tailored meals (Mom's Meals), a YMCA membership, or the SKY Meditation Program. Researchers will be looking at how many people stay in the program and how well they stick to the foundational support sessions. The study is currently recruiting 64 participants.
- Study design
- This is a pilot randomized factorial study involving 64 participants. It is designed to evaluate different combinations of behavioral interventions.
- What's involved
- You would participate in a 6-month behavioral intervention, including a 10-week foundational program. Your retention will be measured at 3 and 6 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for six months after starting the intervention.
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Scalable Behavioral Program for Weight Loss Maintenance After GLP-1 and Anti-Obesity Medication Discontinuation
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Holly Wyatt, MD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Percentage of participants retention3 months, 6 months,
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 sessions10 weeks
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.