An interventional study of Weight Loss Maintenance Program (Foundational) and Mom's Meals in Weight Loss, GLP - 1 and Weight Loss Maintenance, sponsored by University of Alabama at Birmingham. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
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.
1,766 studies on the registry are indexed under Weight Loss; 277 are open to participants now.
This study's planned enrollment of 64 is below the median of 73 across 1,496 interventional studies indexed under Weight Loss.
Browse Weight Loss studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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) · Behavioral: Mom's Meals · Behavioral: YMCA Membership · Behavioral: SKY Meditation Program
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) · Behavioral: Mom's Meals · Behavioral: YMCA Membership
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) · Behavioral: Mom's Meals · Behavioral: SKY Meditation Program
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) · Behavioral: 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: (2) YMCA membership to support physical activity, and (3) the SKY Meditation program to support mind-based practices.
Behavioral: Weight Loss Maintenance Program (Foundational) · Behavioral: YMCA Membership · Behavioral: SKY Meditation Program
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) · Behavioral: YMCA Membership
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) · Behavioral: SKY Meditation Program
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.
Medically tailored meals
YMCA membership to support physical activity
The SKY Meditation program to support mind-based practices
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.
Time frame: 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.
Time frame: 10 weeks
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.
Time frame: Baseline, 3 months, 6 moths
Plan to share: 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.
Supporting information: Study protocol, Sap, Analytic code
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham