Clinical trial

Scalable Behavioral Program for Weight Loss Maintenance After GLP-1 and Anti-Obesity Medication Discontinuation

Opening soon · Not applicable · 1 countries · Registry ID NCT07535892

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionWeight Loss, GLP - 1, Weight Loss Maintenance, Obesity & Overweight

Full registry 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

Treatments and study arms

Weight Loss Maintenance Program (Foundational)

Behavioral

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.

Mom's Meals

Behavioral

Medically tailored meals

YMCA Membership

Behavioral

YMCA membership to support physical activity

SKY Meditation Program

Behavioral

The SKY Meditation program to support mind-based practices

Primary outcomes

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Alabama at Birmingham🇺🇸 Birmingham, Alabama, United States
Holly Wyatt, MDContact
Holly Wyatt, MDPrincipal Investigator