Actively Recruiting
Food and Fitness With Medicine (FFWM)
Led by Ohio State University · Updated on 2026-02-23
200
Participants Needed
4
Research Sites
163 weeks
Total Duration
On this page
Sponsors
O
Ohio State University
Lead Sponsor
A
American Heart Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Food and Fitness With Medicine (FFWM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of at least one of the following: hypertension, type 2 diabetes, hyperlipidemia, chronic kidney disease, or metabolic syndrome
- At least 18 years old at the time of signing consent
- Reliable transportation to attend Exercise is Medicine sessions
- Access to an internet-enabled device
- No objections to online grocery shopping, home food deliveries, or nutrition counseling
- Residence meets Instacart delivery requirements (non-institutionalized)
- Willing to use a personal credit card for Instacart back-up payments
- Ability to speak English to consent and engage in programs
- Clinically prescribed GLP-1RA's
You will not qualify if you...
- Conditions affecting digestion, metabolism, or food intake (e.g., surgical loss of digestive organs, pancreatic dysfunction, bariatric surgery, brain surgery altering cognition)
- Uncontrolled mental illness disorders not well-managed (e.g., schizophrenia, bipolar disorder, major depression)
- Familial history of certain cancers (e.g., multiple endocrine neoplasia, medullary thyroid carcinoma)
- Active digestive illnesses (e.g., Celiac disease, irritable bowel syndrome, chronic malabsorption)
- Psychiatric or general illnesses posing risk as determined by investigator
- Renal impairment with eGFR less than 60 ml/min/1.73m2
- Any factor compromising ability to participate
- Recent participation (within 3 months) in other behavioral nutrition trials or programs
- Currently pregnant or planning pregnancy during the study
- Unwilling to provide urine, blood, or stool samples
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Ohio State Healthy Community Center
Columbus, Ohio, United States, 43062
Active, Not Recruiting
2
Ohio State East Hospital
Columbus, Ohio, United States, 43203
Not Yet Recruiting
3
Martha Morehouse
Columbus, Ohio, United States, 43221
Actively Recruiting
4
Ohio State Outpatient Care Upper Arlington
Upper Arlington, Ohio, United States, 43221
Active, Not Recruiting
Research Team
J
Jenna N Hauben, BS
CONTACT
C
Cara L Chase, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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