Food and Fitness With Medicine (FFWM) (FFWM)

Food and Fitness With Medicine

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes; Cardiovascular Kidney Metabolic Syndrome
• Intervention / Treatment: Behavioral: Exercise is Medicine (EIM); Behavioral: Culinary Education; Behavioral: Food is Medicine; Behavioral: Nutrition Counseling; Behavioral: Participant Website

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jenna N Hauben, BS; Phone Number: 9083344689; Email: jenna.hauben@osumc.edu
• Study Contact Backup: Name: Cara L Chase, BS; Phone Number: 5032789721; Email: cara.chase@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43062
      • Active, not recruiting
      • Ohio State Healthy Community Center
    • Columbus, Ohio, United States, 43203
      • Not yet recruiting
      • Ohio State East Hospital
      • Contact: Luiza Reopell, MBA; Phone Number: 614-572-9191; Email: luiza.reopell@osumc.edu
    • Columbus, Ohio, United States, 43221
      • Recruiting
      • Martha Morehouse
      • Contact: Jenna Hauben; Phone Number: 908-334-4689; Email: jenna.hauben@osumc.edu
    • Upper Arlington, Ohio, United States, 43221
      • Active, not recruiting
      • Ohio State Outpatient Care Upper Arlington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.
• No objections to online grocery shopping, home food deliveries, or nutrition counseling.
• Residence meets Instacart delivery requirements (e.g., non-institutionalized).
• Participant is willing to use a personal credit card for Instacart back-up payments.
• Participants must speak English to be able to consent and engage in FIM and EIM programs.
• Participant has been clinically prescribed GLP-1RA's.

Exclusion Criteria:

• 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).
• Comorbidities such as psychiatric or general illness that may put the subject at risk as determined by the investigator/s.
• Renal impairment, eGFR < 60 ml/min/1.73m2
• Factor which, in the investigator's opinion, is likely to compromise the subject's ability to participate in the study.
• Recent participation (e.g., 3 months) in other behavioral nutrition trials or programs (i.e., bariatric programs, diabetes education programs).
• Currently pregnant or planning to become pregnant during the study.
• Participant is not willing to provide a urine, blood, or stool sample.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FFWM+; 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); During Phase 1 (Weeks 1-12), participants are enrolled in a comprehensive 12-week fitness education and training program.; Behavioral: Culinary Education; During Phase 1 & 2, participants receive monthly hybrid cooking demonstrations with culinary training.; Behavioral: Food is Medicine; During Phase 1 (Weeks 1-12), participants receive bi-weekly medically tailored grocery vouchers.; Behavioral: Nutrition Counseling; During Phase 1 (Weeks 1-12), participants engage in weekly behavioral nutrition counseling.; Behavioral: Participant Website; During Phases 1 and 2, participants will receive digital behavioral reinforcers and access to a secure web portal that provides evidence-based resources.
No Intervention: Standard Care; Control Group - access to optional cooking demos

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	0, 12, and 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	0, 12, and 24 weeks
Hip Circumference	Hip circumference will be measured with a measuring tape following the current NHANES Anthropometry Procedures Manual.	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.	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).	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.	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.	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).	0, 12, and 24 weeks
Waist Circumference	Waist circumference will be measured with a measuring tape following the current NHANES Anthropometry Procedures Manual.	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%).	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).	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.	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.	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).	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.	0, 12, 24 and weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
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.	0, 12, and 24 weeks
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.	0, 12, and 24 weeks

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Colleen K Spees, PhD, MEd, RD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: June 4, 2025
• First Submitted That Met QC Criteria: June 17, 2025
• First Posted (Actual): June 19, 2025

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: GLP-1; Behavior; Nutrition; Type 2 Diabetes; Fitness; Weight; Food is Medicine; Medically Tailored Groceries; Cardiovascular-kidney-metabolic; Exercise is Medicine; Post-menopausal Women; Glucagon-like Peptide 1 Receptor Agonists
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Diabetes Mellitus, Type 2; Body Weight; Behavior
• Other Study ID Numbers: STUDY20250193

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No