Food and Fitness With Medicine (FFWM) for Cardio-Kidney Metabolic Syndrome and Type 2 Diabetes

This study, called Food and Fitness With Medicine (FFWM), is looking at how a program combining exercise, cooking classes, healthy food vouchers, and nutrition counseling affects post-menopausal women with stage 2 cardio-kidney metabolic syndrome (a group of conditions that increase your risk of heart disease, stroke, and type 2 diabetes) and type 2 diabetes. The main goal is to see if this program helps women stay on their GLP-1 receptor agonist (GLP-1RA) medication, which is used to treat type 2 diabetes. You can join if you are at least 18 years old, have certain health conditions like high blood pressure or type 2 diabetes, have reliable transportation for exercise sessions, and access to an internet-enabled device. The study is currently unclear on its recruitment status and plans to enroll 200 participants.

Study design: This is a 24-week randomized controlled trial, meaning participants will be assigned by chance to different groups. It plans to enroll 200 post-menopausal women.
What's involved: You would participate in a 12-week fitness program, monthly cooking demonstrations, receive bi-weekly grocery vouchers for 12 weeks, and have weekly nutrition counseling for 12 weeks. You will also have access to a website with resources for the full 24 weeks.
Compensation: Not stated in the trial record.
Follow-up: The study will measure outcomes at 0, 12, and 24 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Food and Fitness With Medicine (FFWM)

Recruiting

NAAges 18+InterventionalSupportive care

Ohio State University

~200 participants

Updated 2026-02-23 on ClinicalTrials.gov

What's tested:Exercise is Medicine (EIM)Culinary EducationFood is MedicineNutrition CounselingParticipant Website

At a glance

Recruiting sites

1 of 4 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

GLP-1 RA discontinuation rates

Measured over 0, 12, and 24 weeks

Conditions

Cardiovascular Kidney Metabolic Syndrome

Type 2 Diabetes

Where it's being run

4 sites across 1 states

Ohio4

Study leadership

Colleen K Spees, PhD, MEd, RD · PRINCIPAL_INVESTIGATOR · Ohio State University

Who to contact

Jenna N Hauben, BS

[email protected]

9083344689

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

GLP-1 RA discontinuation rates0, 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).

Trialytics