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

Description

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).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, avoidan

Trial Eligibility

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 Info

Interventions

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