University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
NCT Number: NCT07535892
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 opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Birmingham, Alabama, 35294, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
YMCA membership to support physical activity
The SKY Meditation program to support mind-based practices
Time frame: 3 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.
Time frame: 10 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.
Time frame: Baseline, 3 months, 6 moths
Participants will be weighed at Baseline, 3 month, and 6 month intervals to see if they have maintained their overall weight loss.
Contact information is provided by the study sponsor or research team.
University of Alabama at Birmingham
Other
Pilot Trial of a Scalable Behavioral Program for Weight Loss Maintenance After GLP-1 and Anti-Obesity Medication Discontinuation
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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