Food and Fitness With Medicine

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.

Eligibility

Age range

18+ years

Sex

Female

Healthy volunteers

No

Interventions

• 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.

Locations (4)