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

Last updated: November 15, 2024
Sponsor: Rutgers, The State University of New Jersey
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Obesity

Metabolic Syndrome

High Cholesterol (Hyperlipidemia)

Treatment

Lifestyle Medicine Program

Medically Tailored Groceries

Clinical Study ID

NCT06461273
Pro2024000459
  • Ages 18-75
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  2. 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 ifAsian 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 kidneydisease (CKD)
  1. 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 Asianancestry, ≥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/ordiastolic blood pressure ≥80 mm Hg and/or use of antihypertensivemedications
  • fasting blood glucose ≥100 mg/dL
  • Diabetes (HbA1c > 6.5%)
  • CKD stage 1-3b
  1. Stage 3 Subclinical cardiovascular disease (CVD) in CKM
  • Risk equivalents of subclinical CVD- High predicted 10-y CVD risk
  1. Stage 4 Clinical CVD in CKM
  • Clinical CVD (coronary heart disease, heart failure, stroke, peripheralartery disease, atrial fibrillation) among individuals withexcess/dysfunctional adiposity, other metabolic risk factors,
  1. Electronic access to MyDataHelps platform either through an internet connecteddevice like a personal computer, Ipad, or their personal phone and consent to itsuse

  2. Must be patient of the NJ Family Practice Center at Rutgers Health/UniversityHospital

Exclusion

Exclusion Criteria:

  1. Cardiovascular and Pulmonary Conditions
  • acute coronary syndrome with coronary artery bypass grafting in the past 3months

  • uncontrolled hypertension with systolic BP > 160 or diastolic BP > 100

  • heart failure American College of Cardiology (ACC)/AHA Stage C and New YorkHeart Association (NYHA) > class II

  • life threatening or uncontrolled arrhythmia

  • hemodynamically relevant valvular heart disease

  • infiltrative heart disease including cardiac amyloidosis, sarcoidosis, Fabry'sdisease

  • 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

  1. Mental and Psychological Conditions
  • active suicidal behavior

  • substantial depressive symptoms. Antidepressant drugs are allowed if the dosehas 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

  1. Musculoskeletal conditions
  • debility resulting in limited unassisted ambulation (being unable to walk 300meters)

  • inability to perform activities of daily living unassisted

  1. Other Major Organ System Conditions
  • very high-risk CKD (Stage 4 or 5 CKD or very high risk per Kidney DiseaseImproving 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)

  1. Administrative
  • participant in diabetes, nutrition, or weight research intervention in last 12months

  • another family member or household member is a study participant. Only onemember of each household may take part in this study.

  • individuals who have started treatment with a class of medications known asGLP-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 forunassisted 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 reliabletransportation, and unemployment

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

Study Design

Total Participants: 37
Treatment Group(s): 2
Primary Treatment: Lifestyle Medicine Program
Phase:
Study Start date:
October 12, 2024
Estimated Completion Date:
July 30, 2025

Study 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).

Connect with a study center

  • Rutgers Health New Jersey Family Practice Center

    Newark, New Jersey 07103
    United States

    Site Not Available

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