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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Exercise is Medicine (EIM)
BehavioralDuring Phase 1 (Weeks 1-12), participants are enrolled in a comprehensive 12-week fitness education and training program.
Culinary Education
BehavioralDuring Phase 1 \& 2, participants receive monthly hybrid cooking demonstrations with culinary training.
Food is Medicine
BehavioralDuring Phase 1 (Weeks 1-12), participants receive bi-weekly medically tailored grocery vouchers.
Nutrition Counseling
BehavioralDuring Phase 1 (Weeks 1-12), participants engage in weekly behavioral nutrition counseling.
Participant Website
BehavioralDuring Phases 1 and 2, participants will receive digital behavioral reinforcers and access to a secure web portal that provides evidence-based resources.
Treatment groups
Trial outcomes
Primary outcomes
GLP-1 RA discontinuation rates
GLP-1RA discontinuation rates will be captured using the electronic medical record to obtain medication name and formulation, dosage and frequency, prescription start and end dates, prescribing provider, refill information and prescription status (active, discontinued, completed), clinic notes or medication reconciliation fields confirming ongoing use or discontinuation, pharmacy records indicating medication pick-up (when available).
Secondary outcomes
American Heart Association (AHA) PREVENT Scores
The AHA PREVENT scores are used in cardiovascular research to estimate the risk of future cardiovascular disease (CVD) based on factors such as BMI, age, sex, cholesterol, blood pressure, smoking, eGFR, diabetes, medication use, UACR, zip, and HbA1c. Scores are reported as a percent risk for CVD using the following scale: low (\<5%), borderline (5% to 7.4%), intermediate (7.5% to 19.9%), and high (\>20%).
Metabolites
Stool and urine samples will be collected from participants to analyze metabolites at 3 study time points. Participants will collect samples and return within 7 days of a clinic visit. Samples will be processed and stored under strict biosafety protocols to maintain integrity.
Life's Essential 8 Scores
The Life's Essential 8 Survey is a combination of questions used to assess and needed to accurately collect data to determine Life's essential 8 (LE8 scores for participants). Questions collect data on lifestyle health behaviors such as sleep patterns and smoking status. The Life's Essential 8 (LE8) is scored on a scale of 0 to 100. The LE8 score is used to assess and track an individual's overall cardiovascular health based on 8 key factors with a higher score indicating better cardiovascular health.
Blood Lipids
Trained phlebotomists will perform a venous blood draw. The total amount of blood that will be collected for lipids (total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL)) for this entire research study (3 time points over 24 weeks) is less than 2.5 mL (\<1 teaspoon).
Other outcomes
Household Size and Relationships
PhenX Household Roster will be used to collect household data. This survey requests participants to provide a list of all individuals currently residing in the household, starting with the person who owns or rents the dwelling (the householder), followed by the householder's spouse or partner, and then other household members. For each individual listed, the respondent will report their relationship to the householder and the householder's spouse, as well as their sex, age, and marital status.
Access to Healthcare
PhenX Health Insurance Coverage screener will be used to asses access to covergae. This brief survey includes questions designed to assess insurance coverage and health insurance type, in order to evaluate participant access to healthcare services.
Cognitive Function
Cognitive function will be assessed using measures from the National Institutes of Health Toolbox Cognition Battery (NIHTB-CB), which yields two primary composite scores: fluid cognition and crystallized cognition. The Fluid Cognition Composite reflects abilities such as processing speed, executive function, and memory. The Crystallized Cognition Composite reflects knowledge and language abilities, such as vocabulary and reading.
Sponsors and contacts
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Ohio State University
Lead sponsor
American Heart Association
Collaborator