Food and Fitness With Medicine (FFWM)

Launched by OHIO STATE UNIVERSITY · Jun 17, 2025

Keywords

ClinConnect Summary

This clinical trial, called Food and Fitness With Medicine (FFWM), is studying how combining healthy eating and exercise with a specific type of medication (called GLP-1 receptor agonists) affects women’s health. The study will last 24 weeks and will include 200 women who have type 2 diabetes along with heart, kidney, or metabolic health problems. The main goal is to see how many women stop taking the medication during the study. Researchers will also look at changes in heart health scores and how the program affects things like body fat, nutrient levels in the skin, and other markers linked to weight loss and heart health.

Women who might be eligible are post-menopausal (meaning they have stopped having periods) and have conditions such as high blood pressure, type 2 diabetes, high cholesterol, kidney problems, or metabolic syndrome. Participants need to be at least 18 years old, have reliable transportation to attend exercise sessions, access to the internet, and be comfortable with online grocery shopping and nutrition counseling. They should also be currently prescribed the medication being studied. During the trial, participants will take part in exercise and nutrition programs and provide samples like blood, urine, or stool to help researchers understand the effects. It’s important to note that the study is not yet recruiting, and some health conditions or recent participation in other similar programs might make someone ineligible.

Gender

FEMALE

Eligibility 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.