Food is Medicine vs Lifestyle Medicine For Cardiovascular Kidney Metabolic (CKM) Syndrome (FiLMED)

Food is Medicine vs Lifestyle Medicine: A Community Based Pragmatic Randomized Control Trial for Patients With Cardiovascular Kidney Metabolic (CKM) Syndrome

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Obesity; Diabetes Mellitus; Metabolic Syndrome; Hyperlipidemias; Kidney Disease, Chronic; Hypertension,Essential
• Intervention / Treatment: Behavioral: Lifestyle Medicine Program; Behavioral: Medically Tailored Groceries

Detailed Description

Many chronic conditions can be prevented, treated and improved, or even reversed through lifestyle modification. The practice and application of lifestyle medicine offers tremendous potential to restore health and reduce healthcare costs. Lifestyle Medicine is the use of evidence-based lifestyle therapeutic intervention-including a whole-food, plant-predominant eating pattern, regular physical activity, restorative sleep, stress management, avoidance of risky substances, and positive social connection-as a primary modality, delivered by clinicians trained and certified in this specialty to prevent, treat, and often reverse chronic disease. Lifestyle Medicine interventions have been applied in clinical, community, and workplace settings to drive health restoration and disease prevention.

In recent times there has been tremendous interest in the development and study of "Food Is Medicine" interventions as evidenced by the creation of a Food is Medicine initiative and inaugural Food is Medicine Summit, by the Department of Health and Human Services (HHS) in fiscal year 2023. Historically Food is Medicine interventions have been applied using 3 modalities:

Produce Prescriptions: Vouchers or restricted debit cards that can be redeemed for produce or direct distributions of produce that are made available to recipients based on a health condition or risk. Produce prescriptions are sometimes paired with services provided by RDNs, such as nutrition education, nutrition resources, supermarket tours, cooking classes, and medical nutrition therapy.

Medically Tailored Groceries: Distributions of unprepared or lightly processed foods that recipients are meant to prepare for consumption at home; the contents are sufficient to prepare nutritionally complete meals or provide a significant portion of the ingredients for such meals, including produce, whole grains and legumes, and lean proteins.

Medically Tailored Meals: Fully prepared meals made available through a referral from a medical professional or healthcare plan that are tailored to the medical needs of the recipient by a Registered Dietitian Nutritionist (RDN). Nutrition assessment, nutrition counseling and medical nutrition therapy are offered along with the meal program.

Food is medicine interventions suggest there is promise in improving not only food security, but health outcomes associated with diet related diseases. Addressing food insecurity with healthful food improving nutrition security is important, however "Food Is Medicine" interventions may not achieve the expected improvements in health outcomes if patient's lifestyle behaviors are not targeted comprehensively within their unique circumstances. This clinical aspect is often missing from the conversation in terms of chronic disease. Relative to "Food is Medicine" interventions, lifestyle medicine interventions are comprehensive expanding beyond nutrition, encompassing physical activity, stress management, smoking cessation, alcohol moderation, adequate sleep, and social connectivity to treat disease and drive health restoration.

The investigators research question is: Does a comprehensive lifestyle medicine intervention (involving culinary education, health education, physical activity, and urban agriculture) more effectively improve cardiometabolic risk factors in participants compared to those who only receive produce food boxes or usual care?

In a pilot pragmatic randomized control trial (pRCT), the investigators hypothesize that a comprehensive lifestyle medicine intervention can improve clinical outcomes (e.g., blood pressure, cholesterol levels, blood sugar levels, body mass index) of people are living with a lifestyle-related non-communicable disease such as obesity, heart disease, or diabetes compared to a medically tailored groceries cohort and usual care (acting as a control).

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • Rutgers Health New Jersey Family Practice Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Cardiovascular Kidney Metabolic (CKM) syndrome as described by the American Heart Association (AHA)

   1. Stage 1 Metabolic Syndrome: Excess and/or dysfunctional adiposity

      • overweight/obesity - BMI ≥25 kg/m2 (or ≥23 kg/m2 if Asian ancestry)
      • abdominal obesity - Waist circumference ≥88/102 cm in women/men (or if Asian ancestry, ≥80/90 cm in women/men) and/or
      • dysfunctional adipose tissue
      • Fasting blood glucose ≥100-124 mg/dL or HbA1c between 5.7% and 6.4%*
      • without the presence of other metabolic risk factors or chronic kidney disease (CKD)

   2. Stage 2 Metabolic Syndrome: Metabolic risk factors and CKD

      • hypertriglyceridemia ≥135 mg/dL
      • hypertension
      • metabolic syndrome (MetS†)
      • waist circumference ≥88 cm for women and ≥102 cm for men (if Asian ancestry, ≥80 cm for women and ≥90 cm for men)
      • high-density cholesterol <40 mg/dL for men and <50 mg/dL for women
      • triglycerides ≥150 mg/dL
      • elevated blood pressure (BP) - systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥80 mm Hg and/or use of antihypertensive medications
      • fasting blood glucose ≥100 mg/dL
      • Diabetes (HbA1c > 6.5%)
      • CKD stage 1-3b

   3. Stage 3 Subclinical cardiovascular disease (CVD) in CKM

      • Risk equivalents of subclinical CVD- High predicted 10-y CVD risk

   4. Stage 4 Clinical CVD in CKM

      • Clinical CVD (coronary heart disease, heart failure, stroke, peripheral artery disease, atrial fibrillation) among individuals with excess/dysfunctional adiposity, other metabolic risk factors,
2. 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
3. Must be patient of the NJ Family Practice Center at Rutgers Health/University Hospital

Exclusion Criteria:

1. 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

2. 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

3. Musculoskeletal conditions

   • debility resulting in limited unassisted ambulation (being unable to walk 300 meters)
   • inability to perform activities of daily living unassisted

4. 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)

5. 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
   • These conditions are considered exclusion criteria due to the potential for it to significantly impact their ability to participate consistently in the study. It can affect the individual's ability to adhere to study protocols, attend follow-up appointments, or impact the generalizability of the study findings. The investigators recognize the importance of addressing these social determinants of health, typically in clinical practice the investigators focus on helping the patient stabilize and resolve health related social needs prior to engaging in a comprehensive therapeutic lifestyle change program.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lifestyle Medicine; 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.	Behavioral: Lifestyle Medicine Program; Participants will engage in culinary and nutrition education for 6 weeks curated by a professional chef working in conjunction with the project team from community partner Ethos Farm to Health. Lessons will be adapted from the American College of Lifestyle Medicine (ACLM) Culinary Medicine Curriculum Participants will engage in exercise sessions on weeks without culinary and nutrition instruction for a total of 6 weeks. Exercise sessions will include a variety of activities to include calisthenics, weight training, walking, running, dance, and games delivered by the Rutgers physical therapy team. Urban Agriculture lessons will occur longitudinally throughout the 12-week course. Participants will learn to cultivate a variety of crops in limited spaces, emphasizing sustainable practices and the importance of local food systems in urban communities. Additionally, this arm will receive a supplemental food box weekly consistent with the dietary pattern set forth by ACLM.
Active Comparator: Food is Medicine; As a comparison group, 20 patients will be randomized to participate in a 12-week medically tailored grocery program.	Behavioral: Medically Tailored Groceries; Participants in the "Food is Medicine" arm will receive a supplemental food box weekly curated by a registered dietician and dietetics students. Each food box will contain seasonally available fruit and vegetables and other items including protein, dairy/cheese, and legumes that may be available at the time of the food box delivery. Each box will contain approximately 8 pounds of food and all participants in this group will receive the same food items. Classes and educational materials provided will be tailored to the specific foods contained in the weekly food box and will include simple preparation methods, recipes, nutrition information and grocery shopping tips.
No Intervention: Usual Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease reversal	Reduction of disease measures below the threshold for diagnosing the target disease/condition with an absence of medications or procedures known to affect those measures.	12 weeks after start of intervention
Medication reduction	A decrease in the prescribed dose to the next appropriate dose of a specific agent for a specific condition	12 weeks after start of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food Security	Defined as access by all members, at all times to have enough food for an active, healthy life	12 weeks after start of intervention
Diet Quality	Diet quality is broadly defined as a dietary pattern or an indicator of variety across key food groups relative to those recommended in dietary guidelines. Diet quality is objectively measured using the Healthy Eating Index (HEI) 2020	12 weeks after start of intervention
Culinary Attitudes and Behaviors	Assessed using the "Cooking With A Chef" survey instrument which consists of 8 scales assessing: 1. availability and accessibility of fruits and vegetables (AAFV), 2. cooking attitudes (CA) 3. cooking behaviors (CB), 4. produce consumption self efficacy (SEPC) , 5. cooking self-efficacy (SEC), 6. self-efficacy for using basic cooking techniques (SECT) and 7. self-efficacy for using fruit, vegetables, and seasonings (SEFVS) 8. knowledge of cooking terms and techniques.	12 weeks after start of intervention
Physical Activity	Self-reported and measured duration and intensity of physical activity	12 weeks after start of intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1C	Measure of glycosylated hemoglobin and diagnostic test for diabetes	12 weeks after start of intervention
Maximum Oxygen Uptake (VO2 Max)	Estimated amount of oxygen uptake possible measured by the YMCA step test.	12 weeks after start of intervention
Total Body Strength as measured by the Isometric Mid-Thigh Pull	Quantitative test of total body strength using an instrumented dead lift technique measured in Newtons of force per kilogram of body weight.	12 weeks after start of intervention
Waist Circumference	a surrogate measure of visceral adiposity and one component of metabolic syndrome	12 weeks after start of intervention
Waist to Hip Ratio	waist circumference measurement divided by the hip circumference measurement. Ratio used to assess non-communicable disease risk	12 weeks after intervention start
Low-Density Lipoprotein Cholesterol (LDL-C)	diagnostic laboratory test assessing low-density lipoprotein cholesterol concentration that correlates with cardiovascular disease risk	12 weeks after intervention start
Blood Pressure	Measurement of arterial wall pressure and risk factor for cardiovascular disease	12 weeks after intervention start
Grip Strength	A simple and reliable measurement of maximum voluntary muscle strength derived from combined contraction of extrinsic and intrinsic hand muscles	12 weeks after intervention start
Body Weight	The mass or quantity of heaviness of an individual, expressed by units of pounds or kilograms	12 weeks after intervention start
Perceived Program Impact	Assessed using "Most Significant Change" tool. It is a qualitative survey tool that assesses an individual's perspective on what caused the most significant change associated with an intervention and why.	12 weeks after intervention start
Non High-Density Lipoprotein Cholesterol (Non-HDL-C)	measure of all atherogenic lipoproteins and cholesterol, including low-density lipoprotein (LDL) but excludes high density lipoprotein (HDL)	12 weeks after intervention start

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: Ethos Farm to Health
• Investigators: Principal Investigator: Andrew Lynch, PT, PhD, Rutgers, The State University of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2024
• Primary Completion (Estimated): July 30, 2025
• Study Completion (Estimated): July 30, 2025

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 11, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Physical Activity; Exercise; Metabolic Syndrome; Type 2 Diabetes; Cardiovascular diseases; Lifestyle Medicine; Dietary Modification; Food Is Medicine; Lifestyle Related Diseases; Cardiovascular Kidney Metabolic Syndrome
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolic Diseases; Disease; Glucose Metabolism Disorders; Renal Insufficiency; Insulin Resistance; Hyperinsulinism; Dyslipidemias; Lipid Metabolism Disorders; Hypertension; Essential Hypertension; Syndrome; Cardiovascular Diseases; Metabolic Syndrome; Kidney Diseases; Renal Insufficiency, Chronic; Hyperlipidemias
• Other Study ID Numbers: Pro2024000459

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No