Clinical trial NCT06461273: Food is Medicine vs Lifestyle Medicine For Cardiovascular Kidney Metabolic (CKM) Syndrome
Official title: Food is Medicine vs Lifestyle Medicine: A Community Based Pragmatic Randomized Control Trial for Patients With Cardiovascular Kidney Metabolic (CKM) Syndrome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Metabolic Syndrome
Obesity
Hypertension,Essential
Hyperlipidemias
Cardiovascular Diseases
Kidney Disease, Chronic
Keywords: Lifestyle Medicine
Food Is Medicine
Metabolic Syndrome
Lifestyle Related Diseases
Cardiovascular diseases
Type 2 Diabetes
Cardiovascular Kidney Metabolic Syndrome
Dietary Modification
Exercise
Physical Activity
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Ethos Farm to Health
First posted: 2024-06-14
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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
   * 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.

Primary outcomes:
measure: Disease reversal
timeFrame: 12 weeks after start of intervention
measure: Medication reduction
timeFrame: 12 weeks after start of intervention
Secondary outcomes:
measure: Food Security
timeFrame: 12 weeks after start of intervention
measure: Diet Quality
timeFrame: 12 weeks after start of intervention
measure: Culinary Attitudes and Behaviors
timeFrame: 12 weeks after start of intervention
measure: Physical Activity
timeFrame: 12 weeks after start of intervention
Other outcomes:
measure: Hemoglobin A1C
timeFrame: 12 weeks after start of intervention
measure: Maximum Oxygen Uptake (VO2 Max)
timeFrame: 12 weeks after start of intervention
measure: Total Body Strength as measured by the Isometric Mid-Thigh Pull
timeFrame: 12 weeks after start of intervention
measure: Waist Circumference
timeFrame: 12 weeks after start of intervention
measure: Waist to Hip Ratio
timeFrame: 12 weeks after intervention start
measure: Low-Density Lipoprotein Cholesterol (LDL-C)
timeFrame: 12 weeks after intervention start
measure: Blood Pressure
timeFrame: 12 weeks after intervention start
measure: Grip Strength
timeFrame: 12 weeks after intervention start
measure: Body Weight
timeFrame: 12 weeks after intervention start
measure: Perceived Program Impact
timeFrame: 12 weeks after intervention start
measure: Non High-Density Lipoprotein Cholesterol (Non-HDL-C)
timeFrame: 12 weeks after intervention start
Locations:
city: Newark
country: United States
facility: Rutgers Health New Jersey Family Practice Center
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Andrew Lynch, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: