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Behavioral Intervention

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

N/A

Recruiting

Led By Andrew Lynch, PT, PhD

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

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)

Cardiovascular and Pulmonary Conditions: acute coronary syndrome with coronary artery bypass grafting in the past 3 months, uncontrolled hypertension with systolic BP > 160 or diastolic BP > 100, heart failure American College of Cardiology (ACC)/AHA Stage C and New York Heart Association (NYHA) > class II, life threatening or uncontrolled arrhythmia, hemodynamically relevant valvular heart disease, infiltrative heart disease including cardiac amyloidosis, sarcoidosis, Fabry's disease, genetic hypertrophic cardiomyopathy, significant pericardial disease, clinically significant congenital heart disease that may be cause of symptoms, significant anemia (hemoglobin <9), severe chronic obstructive pulmonary disease (oxygen or steroid dependent), severe restrictive pulmonary disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks after intervention start

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a 3-month program that includes urban farming, nutrition education, cooking classes, and exercise to see if it helps people with heart, kidney, and metabolic problems like high blood pressure

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the interventions involve lifestyle changes such as diet modification and exercise rather than medication or surgery there are generally minimal side effects expected. However individual experiences may vary; some might experience muscle soreness from new physical activities or digestive changes due to diet adjustments.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe heart or lung conditions that are uncontrolled or treated in the last 3 months.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks after start of intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks after start of intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks after start of intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease reversal

Medication reduction

Secondary study objectives

Culinary Attitudes and Behaviors

Diet Quality

Food Security

+1 more

Other study objectives

Blood Pressure

Body Weight

Grip Strength

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 3Eligibility criteria met