---
title: Scalable Behavioral Program for Weight Loss Maintenance After GLP-1 and Anti-Obesity Medication Discontinuation
nct_id: NCT07535892
overall_status: NOT_YET_RECRUITING
phase: NA
sponsor: University of Alabama at Birmingham
study_type: INTERVENTIONAL
primary_condition: Weight Loss
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07535892.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07535892"
ct_last_update_post_date: 2026-04-17
last_seen_at: "2026-05-12T07:20:25.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Scalable Behavioral Program for Weight Loss Maintenance After GLP-1 and Anti-Obesity Medication Discontinuation

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

**NCT ID:** [NCT07535892](https://clinicaltrials.gov/study/NCT07535892)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 64
- **Lead Sponsor:** University of Alabama at Birmingham
- **Collaborators:** National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- **Conditions:** Weight Loss, GLP - 1, Weight Loss Maintenance, Obesity & Overweight
- **Start Date:** 2026-06-01
- **Completion Date:** 2029-02-28
- **CT.gov Last Update:** 2026-04-17

## Brief Summary

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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Group 1: WLM Program + Mom's Meals + YMCA + SKY** (ACTIVE_COMPARATOR) — 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.
- **Group 2: WLM Program + Mom's Meals + YMCA** (ACTIVE_COMPARATOR) — 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.
- **Group 3: WLM Program + Mom's Meals + SKY** (ACTIVE_COMPARATOR) — 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.
- **Group 4: WLM Program + Mom's Meals** (ACTIVE_COMPARATOR) — 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).
- **Group 5: WLM Program + YMCA + SKY** (ACTIVE_COMPARATOR) — 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.
- **Group 6: WLM Program + YMCA** (ACTIVE_COMPARATOR) — 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.
- **Group 7: WLM Program + SKY** (ACTIVE_COMPARATOR) — 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.
- **Group 8: Foundational WLM Program Only** (ACTIVE_COMPARATOR) — Eight participants will receive the 10-week foundational program. One group (n=8) will receive only the foundational program without any additional components.

## Interventions

- **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 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.
- **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

- **Overall Weight Loss Maintenance without medication** _(time frame: Baseline, 3 months, 6 moths)_

## Locations (1)

- University of Alabama at Birmingham, Birmingham, Alabama, United States

## Recent Field Changes (last 30 days)

- `outcomes.secondary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of alabama at birmingham|birmingham|alabama|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT07535892.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT07535892*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*