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

NCT ID: NCT06461273

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-12
• Study Completion Date: 2025-07-30

Brief Summary

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).

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).

Conditions

Diabetes Mellitus; Metabolic Syndrome; Obesity; Hypertension,Essential; Hyperlipidemias; Cardiovascular Diseases; Kidney Disease, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Lifestyle Medicine Program

Intervention Type: BEHAVIORAL

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.

Food is Medicine

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

Group Type: ACTIVE_COMPARATOR

Medically Tailored Groceries

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ethos Farm to Health

UNKNOWN

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Andrew D. Lynch, PT, PhD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew Lynch, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

Rutgers Health New Jersey Family Practice Center

Newark, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro2024000459

Identifier Type: -

Identifier Source: org_study_id