Health Trials

About this trial

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 criteria

Qualifiers

Diagnosis of at least one of the following conditions: hypertension, type 2 diabetes, hyperlipidemia, chronic kidney disease, and/or metabolic syndrome.

At least 18 years of age at the time of signing consent.

Participants must have reliable transportation to attend Exercise is Medicine sessions.

Access to an internet-enabled device.

Disqualifiers

Conditions that impact digestion, metabolism, or food intake (e.g. surgical loss of esophagus, stomach, or colon, pancreatic dysfunction, bariatric surgery, brain surgery that alters cognition, etc.).

Participants with uncontrolled mental illness disorders (e.g., schizophrenia, bipolar disorder, major depression, etc.) that are not well-managed or controlled through treatment, as determined by the study team.

Familial history of certain cancers (e.g., multiple endocrine neoplasia, medullary thyroid carcinoma, etc.).

Active digestive illnesses (i.e., Celiac disease, irritable bowel syndrome, chronic malabsorption).

Trial design

Treatments tested in this trial

  • Exercise is Medicine (EIM)
  • Culinary Education
  • Food is Medicine
  • Nutrition Counseling
  • Participant Website

Treatment groups

200 Participants
are divided into 2 treatment groups

Locations

4
Martha Morehouse43221, ColumbusOhio, United States
Ohio State East Hospital43203, ColumbusOhio, United States
Ohio State Healthy Community Center43062, ColumbusOhio, United States
Ohio State Outpatient Care Upper Arlington43221, Upper ArlingtonOhio, United States

Sponsors and collaborators

Ohio State University

Lead sponsor

American Heart Association

Collaborator

Source ClinicalTrials.gov