Cardiovascular Kidney Metabolic SyndromeFFWMNCT07027995
Food and Fitness With Medicine (FFWM)
A study testing Exercise is Medicine (EIM), Culinary Education and Food is Medicine in people with Cardiovascular Kidney Metabolic Syndrome and Type 2 Diabetes, run by Ohio State University at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cardiovascular Kidney Metabolic Syndrome, Type 2 Diabetes
- What is being tested?
- Exercise is Medicine (EIM), Culinary Education and Food is Medicine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 Jan 2026to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 2 recruiting
- Active, not recruiting
Ohio State Healthy Community Center
Columbus, Ohio, 43062
- Not yet recruiting
Ohio State East Hospital
Columbus, Ohio, 43203
Luiza Reopell, MBA, 614-572-9191, luiza.reopell@osumc.edu
- Recruiting
Martha Morehouse
Columbus, Ohio, 43221
Jenna Hauben, 908-334-4689, jenna.hauben@osumc.edu
- Active, not recruiting
Ohio State Outpatient Care Upper Arlington
Upper Arlington, Ohio, 43221
About this study
Official title: 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.
- Being tested
- Exercise is Medicine (EIM), Culinary Education, Food is Medicine, Nutrition Counseling, Participant Website
- Keywords
- Food is Medicine, Cardiovascular-kidney-metabolic, Exercise is Medicine, Post-menopausal Women, Medically Tailored Groceries, Type 2 Diabetes, Glucagon-like Peptide 1 Receptor Agonists, Nutrition, Behavior, GLP-1, Weight, Fitness
- Medical subject headings
- Diabetes Mellitus, Type 2, Behavior, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise is Medicine (EIM)Behavioural
During Phase 1 (Weeks 1-12), participants are enrolled in a comprehensive 12-week fitness education and training program.
Culinary EducationBehavioural
During Phase 1 \& 2, participants receive monthly hybrid cooking demonstrations with culinary training.
Food is MedicineBehavioural
During Phase 1 (Weeks 1-12), participants receive bi-weekly medically tailored grocery vouchers.
Nutrition CounselingBehavioural
During Phase 1 (Weeks 1-12), participants engage in weekly behavioral nutrition counseling.
Participant WebsiteBehavioural
During Phases 1 and 2, participants will receive digital behavioral reinforcers and access to a secure web portal that provides evidence-based resources.
| Study group | Role | What they receive |
|---|---|---|
| FFWM+ | Experimental | Intervention Group receives medically tailored groceries and culinary training, fitness education and training, behavioral reinforcers, and access to a secure web portal. Receives: Behavioral: Exercise is Medicine (EIM); Behavioral: Culinary Education; Behavioral: Food is Medicine; Behavioral: Nutrition Counseling; Behavioral: Participant Website |
| Standard Care | No intervention | Control Group - access to optional cooking demos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 0, 12, and 24 weeks
Secondary outcomes (15)
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%).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 0, 12, and 24 weeks
Hip Circumference
Hip circumference will be measured with a measuring tape following the current NHANES Anthropometry Procedures Manual.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 0, 12, and 24 weeks
Waist Circumference
Waist circumference will be measured with a measuring tape following the current NHANES Anthropometry Procedures Manual.
Measured: 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.
Measured: 0, 12, 24 and weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start14 Jan 2026
- Primary completionNov 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Kidney Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Colleen Spees, PhD, RD, FAND, FAHA, Ohio State University
- Investigators
- Colleen K Spees, PhD, MEd, RD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027995
- Sponsor's protocol ID
- STUDY20250193
- Acronym
- FFWM
- Status last verified
- Feb 2026
- First submitted
- 4 Jun 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food and Fitness With Medicine
- ClinicalTrials.gov ID
- NCT07027995
- Acronym / sponsor ID
- FFWM / STUDY20250193
- Keywords
- Food is Medicine, Cardiovascular-kidney-metabolic, Exercise is Medicine, Post-menopausal Women, Medically Tailored Groceries, Type 2 Diabetes, Glucagon-like Peptide 1 Receptor Agonists, Nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FFWM+ | Experimental | Behavioral: Exercise is Medicine (EIM), Behavioral: Culinary Education, Behavioral: Food is Medicine, Behavioral: Nutrition Counseling, Behavioral: Participant WebsiteIntervention Group receives medically tailored groceries and culinary training, fitness education and training, behavioral reinforcers, and access to a secure web portal. |
| Standard Care | No intervention | –Control Group - access to optional cooking demos |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise is Medicine (EIM)During Phase 1 (Weeks 1-12), participants are enrolled in a comprehensive 12-week fitness education and training program. | Behavioural | FFWM+ |
| Culinary EducationDuring Phase 1 \& 2, participants receive monthly hybrid cooking demonstrations with culinary training. | Behavioural | FFWM+ |
| Food is MedicineDuring Phase 1 (Weeks 1-12), participants receive bi-weekly medically tailored grocery vouchers. | Behavioural | FFWM+ |
| Nutrition CounselingDuring Phase 1 (Weeks 1-12), participants engage in weekly behavioral nutrition counseling. | Behavioural | FFWM+ |
| Participant WebsiteDuring Phases 1 and 2, participants will receive digital behavioral reinforcers and access to a secure web portal that provides evidence-based resources. | Behavioural | FFWM+ |
Primary outcome
GLP-1 RA discontinuation rates
Time frame: 0, 12, and 24 weeks
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).
15 secondary outcomes
American Heart Association (AHA) PREVENT Scores
Time frame: 0, 12, and 24 weeks
Metabolites
Time frame: 0, 12, and 24 weeks
Life's Essential 8 Scores
Time frame: 0, 12, and 24 weeks
Blood Lipids
Time frame: 0, 12, and 24 weeks
Body Composition
Time frame: 0, 12, and 24 weeks
Dietary Patterns
Time frame: 0, 12, and 24 weeks
Hip Circumference
Time frame: 0, 12, and 24 weeks
Dermal Carotenoid Scores
Time frame: 0, 12, and 24 weeks
Blood Pressure
Time frame: 0, 12, and 24 weeks
Nutrition Security
Time frame: 0, 12, 24 weeks.
Social and Emotional Wellbeing
Time frame: 0, 12, and 24 weeks
Social Needs
Time frame: 0, 12, and 24 weeks
HbA1c
Time frame: 0, 12, and 24 weeks
Waist Circumference
Time frame: 0, 12, and 24 weeks
Food Noise
Time frame: 0, 12, 24 and weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Colleen K Spees, PhD, MEd, RD principal investigator
Ohio State University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise is Medicine (EIM), Culinary Education and Food is Medicine in people with Cardiovascular Kidney Metabolic Syndrome and Type 2 Diabetes, run by Ohio State University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenna N Hauben, BS (9083344689, jenna.hauben@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GLP-1 RA discontinuation rates (time frame: 0, 12, and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.