Phase
Condition
Obesity
Metabolic Syndrome
High Cholesterol (Hyperlipidemia)
Treatment
Lifestyle Medicine Program
Medically Tailored Groceries
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Cardiovascular Kidney Metabolic (CKM) syndrome as described by the American HeartAssociation (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 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)
- 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
- 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, peripheralartery disease, atrial fibrillation) among individuals withexcess/dysfunctional adiposity, other metabolic risk factors,
Electronic access to MyDataHelps platform either through an internet connecteddevice like a personal computer, Ipad, or their personal phone and consent to itsuse
Must be patient of the NJ Family Practice Center at Rutgers Health/UniversityHospital
Exclusion
Exclusion Criteria:
- 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
- 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
- Musculoskeletal conditions
debility resulting in limited unassisted ambulation (being unable to walk 300meters)
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 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)
- 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
Study Description
Connect with a study center
Rutgers Health New Jersey Family Practice Center
Newark, New Jersey 07103
United StatesSite Not Available
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