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Not yet recruiting Not applicable NCT07535892

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

No applicable phase (e.g. observational)
Conditions: Weight Loss GLP - 1 Weight Loss Maintenance Obesity & Overweight

Sponsor: University of Alabama at Birmingham

trial.available_in: БГ
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.
Who can participate
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
Interventions
Weight Loss Maintenance Program (Foundational)
BEHAVIORAL
Mom's Meals
BEHAVIORAL
YMCA Membership
BEHAVIORAL
SKY Meditation Program
BEHAVIORAL
Locations 1
United States (1)
University of Alabama at Birmingham
Birmingham , Alabama
Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.06.2026
Completion date
28.02.2029
Registry ID
NCT07535892
Source
clinicaltrials.gov
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