Food vs Lifestyle Programs for Heart and Kidney Health
(FiLMED Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAndrew Lynch, PT, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Rutgers, The State University of New Jersey

No Placebo Group

Trial Summary

What is the purpose of this trial?

The investigators are piloting a 3 month community-based lifestyle medicine program that incorporates experiences and education in urban agriculture, nutrition, culinary arts, and physical fitness to test the hypothesis whether this improves clinical and socio-behavioral outcomes of participants with Cardiovascular Kidney Metabolic (CKM) syndrome (high blood pressure, diabetes, high cholesterol, heart disease, and obesity) in comparison to the current medical care model (usual care) or providing healthy produce (medically tailored groceries).

Research Team

Andrew Lynch, PT, PhD

Principal Investigator

Rutgers, The State University of New Jersey

Eligibility Criteria

This trial is for individuals with Cardiovascular Kidney Metabolic syndrome, which includes conditions like high blood pressure, diabetes, high cholesterol, heart disease, and obesity. Participants should have a BMI of at least 25 (or 23 if Asian), waist measurements above certain thresholds based on gender and ancestry, fasting blood glucose or HbA1c in specified ranges without other metabolic risks or chronic kidney disease.

Inclusion Criteria

Electronic access to MyDataHelps platform either through an internet connected device like a personal computer, iPad, or their personal phone and consent to its use

Must be a patient of the NJ Family Practice Center at Rutgers Health/University Hospital

I have been diagnosed with CKM syndrome.

Exclusion Criteria

Mental and Psychological Conditions: active suicidal behavior, substantial depressive symptoms. Antidepressant drugs are allowed if the dose has been stable for 3 months, uncontrolled major psychiatric illness (schizophrenia, bipolar, dementia), history of drug or alcohol abuse or dependency within the past 12 months, history of medical noncompliance, Intellectual disability resulting in inability to make adult decisions

I cannot walk 300 meters by myself or do daily tasks without help.

Administrative: participant in diabetes, nutrition, or weight research intervention in last 12 months, another family member or household member is a study participant. Only one member of each household may take part in this study, individuals who have started treatment with a class of medications known as GLP-1 within 120 days of the program start, individuals who have undergone bariatric surgery, participants without smartphone or web access, individuals who are not proficient in English to a level that would allow for unassisted understanding of study materials and informed consent documentation, as well as effective communication with the research team, individuals currently facing acute unresolved health-related social needs, including but not limited to, unstable housing, lack of reliable transportation, and unemployment

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Treatment Details

Interventions

Lifestyle Medicine Program (Behavioral Intervention)
Medically Tailored Groceries (Behavioral Intervention)

Trial OverviewThe study is testing a community-based lifestyle program against usual medical care and providing healthy groceries. The program includes urban agriculture education, nutrition classes, culinary arts training, and physical fitness activities to see if these improve health outcomes for people with CKM syndrome over three months.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: Lifestyle MedicineExperimental Treatment1 Intervention

20 Patients will participate in a lifestyle medicine program that includes activities and lessons in urban agriculture, nutrition education, culinary education, and exercise with a team that includes a chef, physician, farmer, and physical therapist. This group will meet one day per week for a 3-hour period for a total of 12-weeks.

Group II: Food is MedicineActive Control1 Intervention

As a comparison group, 20 patients will be randomized to participate in a 12-week medically tailored grocery program.

Group III: Usual CareActive Control1 Intervention

The usual care arm will serve as the control group with a total of 20 patients. The control arm will undergo the standard of care and continue their current treatment plan as coordinated with their primary care physician throughout the course of the study.