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NCT Number: NCT07535892

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location contact

Holly Wyatt, MD

CONTACT

[email protected]

205-975-6270

Holly Wyatt, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Percentage of participants retention

    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.

  2. Percentage of participants that adhered to the 10-week foundational support sessions

    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.

Secondary outcomes

  1. Overall Weight Loss Maintenance without medication

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Holly Wyatt, MD

CONTACT

[email protected]

303-378-6720

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 17, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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