An interventional study of Exercise is Medicine (EIM) and Culinary Education in Cardiovascular Kidney Metabolic Syndrome and Type 2 Diabetes, sponsored by Ohio State University. Recruiting at 4 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-23.
Sponsored by Ohio State University · Not applicable, Interventional, and Supportive care
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.
Exclusion Criteria:
Intervention Group receives medically tailored groceries and culinary training, fitness education and training, behavioral reinforcers, and access to a secure web portal.
Behavioral: Exercise is Medicine (EIM) · Behavioral: Culinary Education · Behavioral: Food is Medicine · Behavioral: Nutrition Counseling · Behavioral: Participant Website
Control Group - access to optional cooking demos
During Phase 1 (Weeks 1-12), participants are enrolled in a comprehensive 12-week fitness education and training program.
During Phase 1 \& 2, participants receive monthly hybrid cooking demonstrations with culinary training.
During Phase 1 (Weeks 1-12), participants receive bi-weekly medically tailored grocery vouchers.
During Phase 1 (Weeks 1-12), participants engage in weekly behavioral nutrition counseling.
During Phases 1 and 2, participants will receive digital behavioral reinforcers and access to a secure web portal that provides evidence-based resources.
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).
Time frame: 0, 12, and 24 weeks
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%).
Time frame: 0, 12, and 24 weeks
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.
Time frame: 0, 12, and 24 weeks
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.
Time frame: 0, 12, and 24 weeks
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).
Time frame: 0, 12, and 24 weeks
Body Composition
We will look at body composition to monitor shifts in muscle mass, body fat, and visceral fat throughout the intervention. Participants will be weighed, wearing light clothing and without shoes, on a calibrated bioelectrical impedance scale (seca mBCA Ultra) capable of analyzing body composition including visceral fat, total body fat percentage, lean body mass, and resting energy expenditure.
Time frame: 0, 12, and 24 weeks
Dietary Patterns
The National Cancer Institute's Dietary History Questionnaire (DHQIII) will be used to assess dietary patterns. The DHQIII tool is validated and assesses dietary intake of 134 foods and beverages in the past 30 days using the Healthy Eating Index score. Scores range 0-100 with higher scores indicating better overall diet quality.
Time frame: 0, 12, and 24 weeks
Hip Circumference
Hip circumference will be measured with a measuring tape following the current NHANES Anthropometry Procedures Manual.
Time frame: 0, 12, and 24 weeks
Dermal Carotenoid Scores
Resonance Raman spectroscopy (RRS) is a non-invasive, validated method of measuring dermal carotenoids as a biomarker of fruit and vegetable intake. The Pharmanex NuSkin Biophotonic Scanner (model S3) uses a standardized RSS protocol intended for nutritional purposes and will not be used to diagnose any disease or medical condition. The scan involves passing a safe LED light across the surface of the skin for approximately 2 minutes. 2-3 measures will be obtained at each time point.
Time frame: 0, 12, and 24 weeks
Blood Pressure
Blood pressure including both systolic and diastolic blood pressure measures will be checked via an automated oscillometric sphygmomanometer (Omron 7 series).
Time frame: 0, 12, and 24 weeks
Nutrition Security
The Center for Nutrition and Health Impact Nutrition Security Screener will be used to assess nutrition security. The Center for Nutrition and Health Impact developed a four-item nutrition security screening tool. Three questions ask about household consumption and concerns around foods thought by the respondent to be good (or not) for health and well-being, and a fourth question asks about food variety.
Time frame: 0, 12, 24 weeks.
Social and Emotional Wellbeing
The De Jon Gierveld Social Isolation Scale will be used to asses social and emotional wellbeing. This short form, 6-item scale can be used as a reliable and valid measurement instrument for overall, emotional, and social loneliness. For this scale each item is assigned a score of 0 or 1 with the total possible score ranging form 0 to 6 with high scores indicating higher rates of loneliness.
Time frame: 0, 12, and 24 weeks
Social Needs
Centers for Medicare and Medicaid Services Accountable Health Communities Health-Related Social Needs Screening Tool will be used to identify needs. Tested by the CMS Innovation, this tool addresses the critical gap between clinical care and community services in the current health care delivery system by testing whether systematically identifying and addressing the health-related social needs of Medicare and Medicaid beneficiaries impacts their total health care costs and improves health. The questionnaire includes 26 questions addressing living situation, food security, transportation, utilities, safety, financial strain, employment, family and community support, education, physical activity, substance abuse, mental health and disabilities. This screening tool is not scored on a standardized scale rather participants screening positive for unmet social needs will be referred to available and free community resources (e.g., Health Impact Ohio, SNAP, MidOhio Food Farmacy, etc).
Time frame: 0, 12, and 24 weeks
HbA1c
Trained phlebotomists will perform a venous blood draw. The total amount of blood that will be collected for HbA1c for this entire research study (3 time points over 24 weeks) is less than 2.5 mL (\<1 teaspoon).
Time frame: 0, 12, and 24 weeks
Waist Circumference
Waist circumference will be measured with a measuring tape following the current NHANES Anthropometry Procedures Manual.
Time frame: 0, 12, and 24 weeks
Food Noise
The Food Noise Questionnaire (FNQ) is a 5-item instrument to assess the frequency and intensity of intrusive food-related thoughts, urges, and preoccupations. Each item is scored 0-5, with a total score range of 0-20. Higher scores indicate greater perceived food noise.
Time frame: 0, 12, 24 and weeks
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.
Time frame: 0, 12, and 24 weeks
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.
Time frame: Baseline
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.
Time frame: 0, 12, and 24 weeks
Plan to share: No
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