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Food and Fitness With Medicine (FFWM)
Sponsor: Ohio State University
Summary
Food and Fitness with Medicine (FFWM) is a 24-week randomized controlled trial (RCT) enrolling 200 post-menopausal women (PMW) with stage 2 cardio-kidney metabolic (CKM) syndrome and type-2 diabetes (T2D) within 6 weeks of initiating glucagon-like peptide-1 receptor agonist (GLP-1RAs) to: 1. Examine discontinuation rates of GLP-1RAs (primary outcome); 2. Compare change in American Heart Association (AHA) PREVENT scores (secondary outcome); and 3. Examine the effects of FFWM on biologic mechanisms responsive to weight loss and cardiovascular health (CVH) including dermal carotenoids, body composition and metabolite biomarkers.
Official title: Food and Fitness With Medicine
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-01-14
Completion Date
2029-03
Last Updated
2026-02-23
Healthy Volunteers
No
Interventions
Exercise is Medicine (EIM)
During Phase 1 (Weeks 1-12), participants are enrolled in a comprehensive 12-week fitness education and training program.
Culinary Education
During Phase 1 \& 2, participants receive monthly hybrid cooking demonstrations with culinary training.
Food is Medicine
During Phase 1 (Weeks 1-12), participants receive bi-weekly medically tailored grocery vouchers.
Nutrition Counseling
During Phase 1 (Weeks 1-12), participants engage in weekly behavioral nutrition counseling.
Participant Website
During Phases 1 and 2, participants will receive digital behavioral reinforcers and access to a secure web portal that provides evidence-based resources.
Locations (4)
Ohio State Healthy Community Center
Columbus, Ohio, United States
Ohio State East Hospital
Columbus, Ohio, United States
Martha Morehouse
Columbus, Ohio, United States
Ohio State Outpatient Care Upper Arlington
Upper Arlington, Ohio, United States