Food and Fitness With Medicine (FFWM)

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. 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.

Eligibility

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.

Conditions3

Locations4 sites

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