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

Pilot Trial of a 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Weight Loss; Obesity & Overweight; GLP - 1; Weight Loss Maintenance
• Intervention / Treatment: Behavioral: Weight Loss Maintenance Program (Foundational); Behavioral: Mom's Meals; Behavioral: YMCA Membership; Behavioral: SKY Meditation Program

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Holly Wyatt, MD; Phone Number: 303-378-6720; Email: drholly@uab.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
      • Contact: Holly Wyatt, MD; Phone Number: 205-975-6270; Email: drholly@uab.edu
      • Principal Investigator: Holly Wyatt, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1: WLM Program + Mom's Meals + YMCA + SKY; Eight participants will be assigned to the foundational WLM program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive three candidate support components: (1) medically tailored meals (Mom's Meals), (2) YMCA membership to support physical activity, and (3) the SKY Meditation program to support mind-based practices.	Behavioral: Weight Loss Maintenance Program (Foundational); 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.; Behavioral: Mom's Meals; Medically tailored meals; Behavioral: YMCA Membership; YMCA membership to support physical activity; Behavioral: SKY Meditation Program; The SKY Meditation program to support mind-based practices
Active Comparator: Group 2: WLM Program + Mom's Meals + YMCA; Eight Participants will be assigned to the foundational program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive two candidate support components: (1) medically tailored meals (Mom's Meals), (2) YMCA membership to support physical activity.	Behavioral: Weight Loss Maintenance Program (Foundational); 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.; Behavioral: Mom's Meals; Medically tailored meals; Behavioral: YMCA Membership; YMCA membership to support physical activity
Active Comparator: Group 3: WLM Program + Mom's Meals + SKY; Eight Participants will be assigned to the foundational program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive candidate support components: (1) medically tailored meals (Mom's Meals), and (3) the SKY Meditation program to support mind-based practices.	Behavioral: Weight Loss Maintenance Program (Foundational); 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.; Behavioral: Mom's Meals; Medically tailored meals; Behavioral: SKY Meditation Program; The SKY Meditation program to support mind-based practices
Active Comparator: Group 4: WLM Program + Mom's Meals; Eight Participants will be assigned to the foundational program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive candidate support components: (1) medically tailored meals (Mom's Meals).	Behavioral: Weight Loss Maintenance Program (Foundational); 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.; Behavioral: Mom's Meals; Medically tailored meals
Active Comparator: Group 5: WLM Program + YMCA + SKY; Eight Participants will be assigned to the foundational program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive candidate support components: (2) YMCA membership to support physical activity, and (3) the SKY Meditation program to support mind-based practices.	Behavioral: Weight Loss Maintenance Program (Foundational); 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.; Behavioral: YMCA Membership; YMCA membership to support physical activity; Behavioral: SKY Meditation Program; The SKY Meditation program to support mind-based practices
Active Comparator: Group 6: WLM Program + YMCA; Eight Participants will be assigned to the foundational program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive support components: (2) YMCA membership to support physical activity.	Behavioral: Weight Loss Maintenance Program (Foundational); 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.; Behavioral: YMCA Membership; YMCA membership to support physical activity
Active Comparator: Group 7: WLM Program + SKY; Eight Participants will be assigned to the foundational program, participants will be randomized using a full factorial 2 × 2 × 2 design to receive support components: (3) the SKY Meditation program to support mind-based practices.	Behavioral: Weight Loss Maintenance Program (Foundational); 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.; Behavioral: SKY Meditation Program; The SKY Meditation program to support mind-based practices
Active Comparator: Group 8: Foundational WLM Program Only; Eight participants will receive the 10-week foundational program. One group (n=8) will receive only the foundational program without any additional components.	Behavioral: Weight Loss Maintenance Program (Foundational); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants retention	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.	3 months, 6 months,
Percentage of participants that adhered to the 10-week foundational support sessions	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.	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Weight Loss Maintenance without medication	Participants will be weighed at Baseline, 3 month, and 6 month intervals to see if they have maintained their overall weight loss.	Baseline, 3 months, 6 moths

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Holly Wyatt, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): February 28, 2029

Study Registration Dates

• First Submitted: April 10, 2026
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: GLP-1; Weight Loss; weight loss maintenance; Anti-Obesity Medication
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Body Weight Changes; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Weight Loss
• Other Study ID Numbers: IRB-300016552; 1R01DK147319-01 (Other Grant/Funding Number: NIDDK)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: At the time of publication(s) related to this trial, a fully de-identified dataset including participant data will be made available so that data analysis can be replicated by other investigators. This dataset will be freely available for download as supplemental materials to manuscripts(s) submitted to PubMed Central.
• IPD Sharing Time Frame: IPD and supporting information will be available at the time of publication of manuscripts associated with this trial.
• IPD Sharing Access Criteria: Freely available for download from PubMed central as supplemental materials to associated manuscripts
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No