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

The University of Alabama at Birmingham

Status: Not yet enrolling

Conditions: Weight Loss; Weight Loss Maintenance; Obesity & Overweight; GLP - 1

Treatments: Behavioral: Mom's Meals; Behavioral: SKY Meditation Program; Behavioral: YMCA Membership; Behavioral: Weight Loss Maintenance Program (Foundational)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07535892

IRB-300016552

1R01DK147319-01 (Other Grant/Funding Number)

Details and patient eligibility

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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64 participants in 8 patient groups

Group 1: WLM Program + Mom's Meals + YMCA + SKY

Active Comparator group

Description:

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.

Treatment:

Behavioral: Weight Loss Maintenance Program (Foundational)

Behavioral: YMCA Membership

Behavioral: SKY Meditation Program

Behavioral: Mom's Meals

Group 2: WLM Program + Mom's Meals + YMCA

Active Comparator group

Description:

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.

Treatment:

Behavioral: Weight Loss Maintenance Program (Foundational)

Behavioral: YMCA Membership

Behavioral: Mom's Meals

Group 3: WLM Program + Mom's Meals + SKY

Active Comparator group

Description:

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.

Treatment:

Behavioral: Weight Loss Maintenance Program (Foundational)

Behavioral: SKY Meditation Program

Behavioral: Mom's Meals

Group 4: WLM Program + Mom's Meals

Active Comparator group

Description:

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).

Treatment:

Behavioral: Weight Loss Maintenance Program (Foundational)

Behavioral: Mom's Meals

Group 5: WLM Program + YMCA + SKY

Active Comparator group

Description:

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.

Treatment:

Behavioral: Weight Loss Maintenance Program (Foundational)

Behavioral: YMCA Membership

Behavioral: SKY Meditation Program

Group 6: WLM Program + YMCA

Active Comparator group

Description:

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.

Treatment:

Behavioral: Weight Loss Maintenance Program (Foundational)

Behavioral: YMCA Membership

Group 7: WLM Program + SKY

Active Comparator group

Description:

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.

Treatment:

Behavioral: Weight Loss Maintenance Program (Foundational)

Behavioral: SKY Meditation Program

Group 8: Foundational WLM Program Only

Active Comparator group

Description:

Eight participants will receive the 10-week foundational program. One group (n=8) will receive only the foundational program without any additional components.

Treatment:

Behavioral: Weight Loss Maintenance Program (Foundational)