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

NCT06461273 | Active Not Recruiting DMC

• 1 other identifier: Pro2024000459
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (2)

• Disease reversal

  Reduction of disease measures below the threshold for diagnosing the target disease/condition with an absence of medications or procedures known to affect those measures.

  12 weeks after start of intervention

• Medication reduction

  A decrease in the prescribed dose to the next appropriate dose of a specific agent for a specific condition

  12 weeks after start of intervention

Secondary Outcomes (4)

• Food Security

  12 weeks after start of intervention

• Diet Quality

  12 weeks after start of intervention

• Culinary Attitudes and Behaviors

  12 weeks after start of intervention

• Physical Activity

  12 weeks after start of intervention

Other Outcomes (11)

• Hemoglobin A1C

  12 weeks after start of intervention

• Maximum Oxygen Uptake (VO2 Max)

  12 weeks after start of intervention

• Total Body Strength as measured by the Isometric Mid-Thigh Pull

  12 weeks after start of intervention

Study Arms (3)

Lifestyle Medicine

EXPERIMENTAL

20 Patients will participate in a lifestyle medicine program that includes activities and lessons in urban agriculture, nutrition education, culinary education, and exercise with a team that includes a chef, physician, farmer, and physical therapist. This group will meet one day per week for a 3-hour period for a total of 12-weeks.

Behavioral: Lifestyle Medicine Program

Food is Medicine

ACTIVE COMPARATOR

As a comparison group, 20 patients will be randomized to participate in a 12-week medically tailored grocery program.

Behavioral: Medically Tailored Groceries

Usual Care

NO INTERVENTION

The usual care arm will serve as the control group with a total of 20 patients. The control arm will undergo the standard of care and continue their current treatment plan as coordinated with their primary care physician throughout the course of the study.

Interventions

Lifestyle Medicine Program BEHAVIORAL

Participants will engage in culinary and nutrition education for 6 weeks curated by a professional chef working in conjunction with the project team from community partner Ethos Farm to Health. Lessons will be adapted from the American College of Lifestyle Medicine (ACLM) Culinary Medicine Curriculum Participants will engage in exercise sessions on weeks without culinary and nutrition instruction for a total of 6 weeks. Exercise sessions will include a variety of activities to include calisthenics, weight training, walking, running, dance, and games delivered by the Rutgers physical therapy team. Urban Agriculture lessons will occur longitudinally throughout the 12-week course. Participants will learn to cultivate a variety of crops in limited spaces, emphasizing sustainable practices and the importance of local food systems in urban communities. Additionally, this arm will receive a supplemental food box weekly consistent with the dietary pattern set forth by ACLM.

Lifestyle Medicine

Medically Tailored Groceries BEHAVIORAL

Participants in the "Food is Medicine" arm will receive a supplemental food box weekly curated by a registered dietician and dietetics students. Each food box will contain seasonally available fruit and vegetables and other items including protein, dairy/cheese, and legumes that may be available at the time of the food box delivery. Each box will contain approximately 8 pounds of food and all participants in this group will receive the same food items. Classes and educational materials provided will be tailored to the specific foods contained in the weekly food box and will include simple preparation methods, recipes, nutrition information and grocery shopping tips.

Food is Medicine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Ethos Farm to Health: collaborator

Study Sites (1)

Rutgers Health New Jersey Family Practice Center

Newark, New Jersey, 07103, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Metabolic Syndrome; Obesity; Essential Hypertension; Hyperlipidemias; Cardiovascular Diseases; Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hypertension; Vascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Behavior

Study Officials

• Andrew Lynch, PT, PhD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 14, 2024
• Study Start: October 12, 2024
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)