Food is Medicine vs Lifestyle Medicine For Cardiovascular Kidney Metabolic (CKM) Syndrome
Completed · Not applicable
Conditions studied: Diabetes Mellitus, Metabolic Syndrome, Obesity, Hypertension,Essential, Hyperlipidemias, Cardiovascular Diseases, Kidney Disease, Chronic
In brief
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).
Key facts
- Study ID
- NCT06461273
- Run by
- Rutgers, The State University of New Jersey
- People needed
- 37
- Starts
- 2024-10-12
- Expected to finish
- 2025-04-11
- Last updated by the study team
- 2026-07-09
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Cardiovascular Kidney Metabolic (CKM) syndrome as described by the American Heart Association (AHA)
- 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)
- 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
- Stage 3 Subclinical cardiovascular disease (CVD) in CKM
- Risk equivalents of subclinical CVD- High predicted 10-y CVD risk
- 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,
- 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
- Must be patient of the NJ Family Practice Center at Rutgers Health/University Hospital
You may not qualify if…
- 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
- 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
- Musculoskeletal conditions
- debility resulting in limited unassisted ambulation (being unable to walk 300 meters)
- inability to perform activities of daily living unassisted
- 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)
Where it is running
- Rutgers Health New Jersey Family Practice Center — Newark, New Jersey, United States
Full record on ClinicalTrials.gov
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