Food and Fitness With Medicine (FFWM)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorOhio State University
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 groupsSponsors and collaborators
Ohio State University
Lead sponsor
American Heart Association
Collaborator
Source ClinicalTrials.gov