NCT07027995

Food and Fitness With Medicine (FFWM)

Food and Fitness With Medicine

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Ohio State University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiovascular Kidney Metabolic Syndrome
• Type 2 Diabetes

Interventions

Type	Name	Description
BEHAVIORAL	Exercise is Medicine (EIM)	During Phase 1 (Weeks 1-12), participants are enrolled in a comprehensive 12-week fitness education and training program.
BEHAVIORAL	Culinary Education	During Phase 1 \& 2, participants receive monthly hybrid cooking demonstrations with culinary training.
BEHAVIORAL	Food is Medicine	During Phase 1 (Weeks 1-12), participants receive bi-weekly medically tailored grocery vouchers.
BEHAVIORAL	Nutrition Counseling	During Phase 1 (Weeks 1-12), participants engage in weekly behavioral nutrition counseling.
BEHAVIORAL	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.

Timeline

• Start date: 2026-01-14
• Primary completion: 2028-11-01
• Completion: 2029-03-01
• First posted: 2025-06-19
• Last updated: 2026-02-23

Locations

4 sites across 1 country: United States