Food and Fitness With Medicine for Post‑menopausal Women with Type 2 Diabetes and Cardio‑Kidney‑Metabolic Syndrome
Food and Fitness With Medicine
This 24‑week randomized test sees if adding tailored groceries, nutrition counseling, culinary education, and supervised exercise helps post‑menopausal women with type 2 diabetes who just started GLP‑1 receptor agonists stay on their medicine and improve heart and metabolic health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ohio State University Academic / other |
| Locations | 4 sites (Columbus, Ohio and 3 other locations) |
| Trial ID | NCT07027995 on ClinicalTrials.gov |
What this trial studies
FFWM is a 24‑week randomized controlled trial enrolling 200 post‑menopausal women with stage 2 cardio‑kidney‑metabolic syndrome and type 2 diabetes within six weeks of starting a GLP‑1 receptor agonist. Participants are randomized to a multi-component intervention combining Exercise is Medicine sessions, culinary education, medically tailored groceries/food delivery, one-on-one nutrition counseling, and a participant website versus usual care. The primary outcome is GLP‑1RA discontinuation rate, with secondary outcomes including change in the American Heart Association PREVENT score and changes in dermal carotenoids, body composition, and metabolite biomarkers. The protocol requires in-person exercise attendance at Ohio State sites and ability to receive online grocery deliveries and use internet-enabled devices.
Who should consider this trial
Good fit: Ideal candidates are post‑menopausal women with type 2 diabetes and stage 2 cardio‑kidney‑metabolic syndrome who have been prescribed a GLP‑1 receptor agonist within the past six weeks, have reliable transportation for exercise sessions, internet access, and live in an area that accepts Instacart delivery.
Not a fit: Patients with major digestive or absorptive conditions (for example prior bariatric surgery, pancreatic dysfunction, or other surgical loss of GI tract), those who cannot use online grocery delivery, non‑English speakers, men, or people who are not recently started on a GLP‑1RA are unlikely to benefit from or be eligible for this program.
Why it matters
Potential benefit: If successful, FFWM could improve medication persistence and produce meaningful gains in cardiovascular and metabolic health for post‑menopausal women on GLP‑1RAs.
How similar studies have performed: Previous programs combining medically tailored food and exercise have improved weight, glycemic control, and cardiovascular risk markers, but applying these supports specifically to improve GLP‑1RA persistence in post‑menopausal CKM patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Columbus, Ohio and 3 other locations
- Ohio State Healthy Community Center — Columbus, Ohio, United States (Active_not_recruiting)
- Ohio State East Hospital — Columbus, Ohio, United States (Not_yet_recruiting)
- Martha Morehouse — Columbus, Ohio, United States (Recruiting)
- Ohio State Outpatient Care Upper Arlington — Upper Arlington, Ohio, United States (Active_not_recruiting)
Study contacts
- Principal investigator: Colleen K Spees, PhD, MEd, RD — Ohio State University
- Study coordinator: Jenna N Hauben, BS
- Email: jenna.hauben@osumc.edu
- Phone: 9083344689
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.