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Food and Fitness With Medicine (FFWM)

Food and Fitness With Medicine

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This 24-week study tests Food and Fitness with Medicine for women after menopause who have type 2 diabetes and stage 2 cardio-kidney metabolic syndrome, a condition involving heart, kidney, and metabolic health. Women join within 6 weeks of starting a GLP-1 medicine. The study looks at whether they stop the medicine and at changes in heart health risk, body fat and muscle, and other health measures.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have at least one of these: high blood pressure, type 2 diabetes, high cholesterol, long-term kidney disease, or metabolic syndrome—a group of health problems that raise heart disease and diabetes risk.
  • Be at least 18 years old when signing the consent form.
  • Have reliable rides to the Exercise is Medicine sessions.
  • Have a device that connects to the internet.
  • Be willing to shop for groceries online, get food deliveries, and receive nutrition advice.
  • Live somewhere Instacart can deliver and be willing to use a personal credit card for backup payments.
  • Speak English well enough to give consent and take part in the food and exercise programs.
  • Have a prescription for a GLP-1 medicine.

Who can't join

  • Have a condition or past surgery that affects digestion, how the body uses food, or eating. This includes weight-loss surgery or brain surgery that affects thinking.
  • Have an active digestive illness, such as celiac disease, irritable bowel syndrome, or ongoing trouble absorbing nutrients.
  • Have a mental illness that is not well controlled, or another illness that the study team thinks makes joining unsafe.
  • Have a family history of certain cancers, such as medullary thyroid cancer, or multiple endocrine neoplasia, which causes tumors in hormone-making glands.
  • Have reduced kidney function, with an eGFR kidney test result below 60.
  • Have another issue the study doctor thinks could keep you from taking part, or have recently joined another nutrition study or program, such as within the past 3 months.
  • Be pregnant or plan to become pregnant during the study.
  • Be unwilling to give urine, blood, or stool samples.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (4)

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