Food vs Lifestyle Programs for Heart and Kidney Health

(FiLMED Trial)

Overseen By Saul Bautista, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: GLP-1

Disqualifiers: Uncontrolled hypertension, Major psychiatric illness, Severe COPD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a community-based lifestyle program can improve heart and kidney health for individuals with Cardiovascular Kidney Metabolic (CKM) syndrome, which includes conditions like high blood pressure, diabetes, and obesity. Participants will join one of three groups: a Lifestyle Medicine Program with activities such as cooking and exercise, a group receiving Medically Tailored Groceries (healthy groceries), or a group continuing their usual care. Ideal participants have conditions like high blood pressure or diabetes but manage daily life without severe restrictions. The trial aims to determine if lifestyle changes can offer better health outcomes compared to standard medical care. As an unphased trial, it provides participants the opportunity to contribute to innovative research that could enhance future health strategies.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it does mention that antidepressant drugs are allowed if the dose has been stable for 3 months, and individuals who have started treatment with GLP-1 medications within 120 days of the program start are excluded.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that lifestyle medicine programs, which include activities like learning about healthy eating and exercising, are generally safe and easy to follow. Recent studies have found that participants often experience improvements in weight, body measurements, and heart health without major side effects. These programs typically involve a plant-based diet, which benefits kidney health and reduces the risk of diseases.

Overall, participants in similar programs report positive results and an improved quality of life. With a focus on diet and exercise, these programs do not involve new drugs or surgeries, usually resulting in fewer side effects. For those considering joining a trial for lifestyle medicine, this research suggests it is likely to be safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how lifestyle changes can improve heart and kidney health. Unlike typical treatments that rely heavily on medications, this study looks at how a lifestyle medicine program, which includes urban agriculture, nutrition and culinary education, and exercise, can make a difference. The program is unique because it brings together a team of diverse professionals, including a chef, physician, farmer, and physical therapist, to guide participants. By comparing this approach with a medically tailored grocery program and usual care, the trial aims to find out how much impact these lifestyle interventions can have on health outcomes.

What evidence suggests that this trial's treatments could be effective for CKM syndrome?

Research shows that lifestyle medicine programs, one of the treatment options in this trial, can greatly improve health for people with conditions like Cardiovascular Kidney Metabolic (CKM) syndrome. Studies have found that lifestyle changes, such as healthier eating and increased exercise, reduce the risk of diabetes by 93% and heart attacks by 81%. Other research highlights benefits like weight loss and lower blood pressure. These programs often lead to better health indicators, such as improved cholesterol levels, even months after completion. Most participants maintain these healthy habits, with about 88% adhering to the changes a year later. Meanwhile, the trial will also evaluate the effectiveness of a medically tailored grocery program, another treatment option, compared to usual care. ^{2 4 6 7 8}

Who Is on the Research Team?

Andrew Lynch, PT, PhD

Principal Investigator

Rutgers, The State University of New Jersey

Are You a Good Fit for This Trial?

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.

Other Major Organ System Conditions: very high-risk CKD (Stage 4 or 5 CKD or very high risk per Kidney Disease Improving Global Outcomes (KDIGO) classification), significant hepatic dysfunction, untreated hypothyroidism or hyperthyroidism, cerebrovascular accident within past 6 months with functional residual deficits, clinically relevant neuromuscular disease, cancer or terminal illness with life expectancy < 3 years, pregnant or may become pregnant in the next 6 months, prior major organ transplant or intent to transplant (on the transplant list)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 12-week lifestyle medicine program or receive medically tailored groceries

12 weeks

1 visit per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lifestyle Medicine Program
• Medically Tailored Groceries

Trial Overview

The 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.

How Is the Trial Designed?

Group I: Lifestyle Medicine Experimental Treatment 1 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 Medicine Active Control 1 Intervention

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

Group III: Usual Care Active Control 1 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.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Ethos Farm to Health

Collaborator

Trials

1

Recruited

40+

Published Research Related to This Trial

In a study of 72 participants in a lifestyle modification program, those with elevated cardiovascular disease (CVD) risk factors but no clinical disease showed equal or greater improvements in heart health compared to those with existing CVD.

The results indicate that intensive lifestyle change programs can be effective for primary prevention of CVD, highlighting their importance for individuals at increased risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive lifestyle modification: impact on cardiovascular disease risk factors in subjects with and without clinical cardiovascular disease. Ellsworth, DL., O'Dowd, SC., Salami, B., et al.[2019]

A study involving 580 participants with coronary artery disease showed that both the Ornish and Benson-Henry lifestyle modification programs significantly improved cardiac risk factors during a 3-month intervention, with many participants maintaining these improvements for up to 24 months.

Motivation to lose weight was a key factor in sustaining weight loss, highlighting the importance of psychological support in lifestyle interventions for heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of lifestyle modification programs on cardiac risk factors. Razavi, M., Fournier, S., Shepard, DS., et al.[2020]

A 6-week lifestyle intervention program for 15 German patients, which included a low-fat vegetarian diet and aerobic exercises, led to significant dietary changes and improved quality of life, demonstrating its feasibility in a rehabilitation setting.

Despite both the intervention and control groups receiving the same lipid-lowering medication (Pravastatin), the lifestyle changes did not provide additional benefits in lowering lipid levels beyond what the medication achieved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Life style changes in patients with myocardial infarct in the framework of intramural and ambulatory rehabilitation--results of a German pilot study]. Scherwitz, LW., Brusis, OA., Kesten, D., et al.[2013]

A pilot plant-based lifestyle medicine program in a safety-net healthcare system led to significant improvements in patient-reported outcomes, including a 7.2% increase in nutrition knowledge and a 12.2% increase in participants reporting good or very good sleep quality after 6 months.

Participants also experienced a reduction in barriers to adopting a plant-based diet and increased physical activity, highlighting the effectiveness of lifestyle medicine interventions in promoting healthier behaviors among low-income populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes from a Pilot Plant-Based Lifestyle Medicine Program in a Safety-Net Setting. Massar, RE., McMacken, M., Kwok, L., et al.[2023]

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