Food is Medicine vs Lifestyle Medicine For Cardiovascular Kidney Metabolic (CKM) Syndrome
NCT06461273 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37
Last updated 2024-11-19
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
Interventions
- BEHAVIORAL
-
Lifestyle Medicine Program
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.
- BEHAVIORAL
-
Medically Tailored Groceries
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.
Sponsors & Collaborators
-
Ethos Farm to Health
collaborator UNKNOWN -
Rutgers, The State University of New Jersey
lead OTHER
Principal Investigators
-
Andrew Lynch, PT, PhD · Rutgers, The State University of New Jersey
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-12
- Primary Completion
- 2025-07-30
- Completion
- 2025-07-30
Countries
- United States
Study Locations
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