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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK147319-01 | Other Grant/Funding Number | NIDDK |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Group 4: WLM Program + Mom's Meals |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Holly Wyatt, MD | Contact | 303-378-6720 | drholly@uab.edu |
| Name | Affiliation | Role |
|---|---|---|
| Holly Wyatt, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
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 and supporting information will be available at the time of publication of manuscripts associated with this trial.
Freely available for download from PubMed central as supplemental materials to associated manuscripts
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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.
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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). |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Mom's Meals | Behavioral | Medically tailored meals |
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| YMCA Membership | Behavioral | YMCA membership to support physical activity |
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| SKY Meditation Program | Behavioral | The SKY Meditation program to support mind-based practices |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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