Food and Fitness With Medicine (FFWM)

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT07027995
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Exercise is Medicine (EIM) — BEHAVIORAL
    During Phase 1 (Weeks 1-12), participants are enrolled in a comprehensive 12-week fitness education and training program.
  • Culinary Education — BEHAVIORAL
    During Phase 1 \& 2, participants receive monthly hybrid cooking demonstrations with culinary training.
  • Food is Medicine — BEHAVIORAL
    During Phase 1 (Weeks 1-12), participants receive bi-weekly medically tailored grocery vouchers.
  • Nutrition Counseling — BEHAVIORAL
    During Phase 1 (Weeks 1-12), participants engage in weekly behavioral nutrition counseling.
  • Participant Website — BEHAVIORAL
    During Phases 1 and 2, participants will receive digital behavioral reinforcers and access to a secure web portal that provides evidence-based resources.

Study Details

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.

Key Dates

Start date
Jan 14, 2026
Status verified
Feb 2026
Primary completion
Nov 30, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: FFWM+
    Intervention Group receives medically tailored groceries and culinary training, fitness education and training, behavioral reinforcers, and access to a secure web portal.
  • No Intervention: Standard Care
    Control Group - access to optional cooking demos

Primary Outcome Measure

GLP-1 RA discontinuation rates [ Time Frame: 0, 12, and 24 weeks ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Martha MorehouseColumbusOhio43221
Jenna Hauben
[email protected]
908-334-4689
Ohio State East HospitalColumbusOhio43203
Luiza Reopell, MBA
[email protected]
614-572-9191
Ohio State Healthy Community CenterColumbusOhio43062-
Ohio State Outpatient Care Upper ArlingtonUpper ArlingtonOhio43221-

Find similar trials in Columbus, OH

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Martha Morehouse· Columbus, OHOhio State East Hospital· Columbus, OHOhio State Healthy Community Center· Columbus, OHOhio State Outpatient Care Upper Arlington· Upper Arlington, OH

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