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

37 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Lifestyle Medicine Program, Medically Tailored Groceries for heart and kidney health?

Research suggests that following a Mediterranean diet, which is part of healthy eating guidelines, can help preserve kidney function and improve heart health. Additionally, dietary behavior interventions have shown improvements in kidney function and quality of life for patients with chronic kidney disease. ^{1 2 3 4 5}

Is the Food vs Lifestyle Programs for Heart and Kidney Health treatment safe for humans?

Research on lifestyle medicine programs, including plant-based diets and weight loss programs, suggests they are generally safe and can improve health outcomes like nutrition knowledge, physical activity, and quality of life. These programs have been studied in various settings and populations, showing positive patient-reported outcomes without significant safety concerns. ^{1 4 5 6 7}

How does the Lifestyle Medicine Program treatment differ from other treatments for heart and kidney health?

The Lifestyle Medicine Program is unique because it focuses on comprehensive lifestyle changes, including a low-fat vegetarian diet, stress management, aerobic exercises, and group support, rather than relying solely on medication. This holistic approach aims to improve heart and kidney health by addressing multiple lifestyle factors, which can lead to significant improvements in quality of life and reduction in risk factors for cardiovascular disease. ^{8 9 10 11 12}

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Mediterranean diet, kidney function, and mortality in men with CKD. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Dietary Modeling of Foods for Advanced CKD Based on General Healthy Eating Guidelines: What Should Be on the Plate? [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Systematic Review and Meta-analyses: Dietary Behavior Interventions in Non-dialysis Chronic Kidney Disease. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Participation in a Structured Weight Loss Program and All-Cause Mortality and Cardiovascular Morbidity in Obese Patients With Chronic Kidney Disease. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Lifestyle and chronic kidney disease: A machine learning modeling study. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes from a Pilot Plant-Based Lifestyle Medicine Program in a Safety-Net Setting. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular disease: optimal approaches to risk factor modification of diet and lifestyle. [2020]

8. Germany 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]. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Effects of lifestyle modification programs on cardiac risk factors. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Intensive lifestyle modification: impact on cardiovascular disease risk factors in subjects with and without clinical cardiovascular disease. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Navigating the Uncharted Waters of a Lifestyle Medicine Fellowship. [2020]

12. Korea (South) pubmed.ncbi.nlm.nih.gov

Improvement on Biometrics in Individuals Undergoing a 10 and 21-Day Lifestyle Intervention in a Lifestyle Medicine Clinic in Mexico. [2022]