Weight LossNCT07535892
Scalable Behavioral Program for Weight Loss Maintenance After GLP-1 and Anti-Obesity Medication Discontinuation
A study testing Weight Loss Maintenance Program (Foundational), Mom's Meals and YMCA Membership in people with Weight Loss and GLP - 1, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Loss, GLP - 1, Weight Loss Maintenance
- What is being tested?
- Weight Loss Maintenance Program (Foundational), Mom's Meals and YMCA Membership
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Holly Wyatt, MD, 205-975-6270, drholly@uab.edu
Holly Wyatt, MD
About this study
Official title: 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.
- Conditions
- Weight Loss, GLP - 1, Weight Loss Maintenance, Obesity & Overweight
- Being tested
- Weight Loss Maintenance Program (Foundational), Mom's Meals, YMCA Membership, SKY Meditation Program
- Keywords
- Weight Loss, GLP-1, Anti-Obesity Medication, weight loss maintenance
- Medical subject headings
- Weight Loss, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight Loss Maintenance Program (Foundational)Behavioural
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 MealsBehavioural
Medically tailored meals
YMCA MembershipBehavioural
YMCA membership to support physical activity
SKY Meditation ProgramBehavioural
The SKY Meditation program to support mind-based practices
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Weight Loss Maintenance Program (Foundational); Behavioral: Mom's Meals; Behavioral: YMCA Membership; Behavioral: SKY Meditation Program |
| 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. Receives: Behavioral: Weight Loss Maintenance Program (Foundational); Behavioral: Mom's Meals; Behavioral: YMCA Membership |
| 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. Receives: Behavioral: Weight Loss Maintenance Program (Foundational); Behavioral: Mom's Meals; Behavioral: SKY Meditation Program |
| 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). Receives: Behavioral: Weight Loss Maintenance Program (Foundational); Behavioral: 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. Receives: Behavioral: Weight Loss Maintenance Program (Foundational); Behavioral: YMCA Membership; Behavioral: SKY Meditation Program |
| 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. Receives: Behavioral: Weight Loss Maintenance Program (Foundational); Behavioral: YMCA Membership |
| 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. Receives: Behavioral: Weight Loss Maintenance Program (Foundational); Behavioral: SKY Meditation Program |
| 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. Receives: Behavioral: Weight Loss Maintenance Program (Foundational) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 weeks
Secondary outcomes (1)
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.
Measured: Baseline, 3 months, 6 moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Apr 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Holly Wyatt, University of Alabama at Birmingham
- Investigators
- Holly Wyatt, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535892
- Sponsor's protocol ID
- IRB-300016552
- Other IDs
- 1R01DK147319-01
- Status last verified
- Jun 2026
- First submitted
- 10 Apr 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of a Scalable Behavioral Program for Weight Loss Maintenance After GLP-1 and Anti-Obesity Medication Discontinuation
- ClinicalTrials.gov ID
- NCT07535892
- Acronym / sponsor ID
- IRB-300016552
- Conditions
- Weight Loss, GLP - 1, Weight Loss Maintenance, Obesity & Overweight
- Keywords
- Weight Loss, GLP-1, Anti-Obesity Medication, weight loss maintenance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1: WLM Program + Mom's Meals + YMCA + SKY | Active comparator | Behavioral: Weight Loss Maintenance Program (Foundational), Behavioral: Mom's Meals, Behavioral: YMCA Membership, Behavioral: SKY Meditation ProgramEight 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 | Behavioral: Weight Loss Maintenance Program (Foundational), Behavioral: Mom's Meals, Behavioral: YMCA MembershipEight 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 | Behavioral: Weight Loss Maintenance Program (Foundational), Behavioral: Mom's Meals, Behavioral: SKY Meditation ProgramEight 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 | Behavioral: Weight Loss Maintenance Program (Foundational), Behavioral: Mom's MealsEight 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 | Behavioral: Weight Loss Maintenance Program (Foundational), Behavioral: YMCA Membership, Behavioral: SKY Meditation ProgramEight 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 | Behavioral: Weight Loss Maintenance Program (Foundational), Behavioral: YMCA MembershipEight 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 | Behavioral: Weight Loss Maintenance Program (Foundational), Behavioral: SKY Meditation ProgramEight 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 | Behavioral: Weight Loss Maintenance Program (Foundational)Eight participants will receive the 10-week foundational program. One group (n=8) will receive only the foundational program without any additional components. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Group 1: WLM Program + Mom's Meals + YMCA + SKY, Group 2: WLM Program + Mom's Meals + YMCA, Group 3: WLM Program + Mom's Meals + SKY, Group 4: WLM Program + Mom's Meals, Group 5: WLM Program + YMCA + SKY, Group 6: WLM Program + YMCA, Group 7: WLM Program + SKY, Group 8: Foundational WLM Program Only |
| Mom's MealsMedically tailored meals | Behavioural | Group 1: WLM Program + Mom's Meals + YMCA + SKY, Group 2: WLM Program + Mom's Meals + YMCA, Group 3: WLM Program + Mom's Meals + SKY, Group 4: WLM Program + Mom's Meals |
| YMCA MembershipYMCA membership to support physical activity | Behavioural | Group 1: WLM Program + Mom's Meals + YMCA + SKY, Group 2: WLM Program + Mom's Meals + YMCA, Group 5: WLM Program + YMCA + SKY, Group 6: WLM Program + YMCA |
| SKY Meditation ProgramThe SKY Meditation program to support mind-based practices | Behavioural | Group 1: WLM Program + Mom's Meals + YMCA + SKY, Group 3: WLM Program + Mom's Meals + SKY, Group 5: WLM Program + YMCA + SKY, Group 7: WLM Program + SKY |
Primary outcome
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.
1 secondary outcome
Overall Weight Loss Maintenance without medication
Time frame: Baseline, 3 months, 6 moths
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Holly Wyatt, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight Loss Maintenance Program (Foundational), Mom's Meals and YMCA Membership in people with Weight Loss and GLP - 1, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Holly Wyatt, MD (303-378-6720, drholly@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants retention (time frame: 3 months, 6 months,). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.