An interventional study of Lifestyle Medicine Program and Medically Tailored Groceries in Diabetes Mellitus, Metabolic Syndrome and Obesity, sponsored by Rutgers, The State University of New Jersey. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by Rutgers, The State University of New Jersey · Not applicable, Interventional, and Treatment
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).
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).
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This study's enrollment of 37 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Cardiovascular Kidney Metabolic (CKM) syndrome as described by the American Heart Association (AHA)
Stage 1 Metabolic Syndrome: Excess and/or dysfunctional adiposity
Stage 2 Metabolic Syndrome: Metabolic risk factors and CKD
Stage 3 Subclinical cardiovascular disease (CVD) in CKM
Stage 4 Clinical CVD in CKM
Exclusion Criteria:
Cardiovascular and Pulmonary Conditions
Mental and Psychological Conditions
Musculoskeletal conditions
Other Major Organ System Conditions
Administrative
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
As a comparison group, 20 patients will be randomized to participate in a 12-week medically tailored grocery program.
Behavioral: Medically Tailored Groceries
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.
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.
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.
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.
Time frame: 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
Time frame: 12 weeks after start of intervention
Food Security
Defined as access by all members, at all times to have enough food for an active, healthy life
Time frame: 12 weeks after start of intervention
Diet Quality
Diet quality is broadly defined as a dietary pattern or an indicator of variety across key food groups relative to those recommended in dietary guidelines. Diet quality is objectively measured using the Healthy Eating Index (HEI) 2020
Time frame: 12 weeks after start of intervention
Culinary Attitudes and Behaviors
Assessed using the "Cooking With A Chef" survey instrument which consists of 8 scales assessing: 1. availability and accessibility of fruits and vegetables (AAFV), 2. cooking attitudes (CA) 3. cooking behaviors (CB), 4. produce consumption self efficacy (SEPC) , 5. cooking self-efficacy (SEC), 6. self-efficacy for using basic cooking techniques (SECT) and 7. self-efficacy for using fruit, vegetables, and seasonings (SEFVS) 8. knowledge of cooking terms and techniques.
Time frame: 12 weeks after start of intervention
Physical Activity
Self-reported and measured duration and intensity of physical activity
Time frame: 12 weeks after start of intervention
Hemoglobin A1C
Measure of glycosylated hemoglobin and diagnostic test for diabetes
Time frame: 12 weeks after start of intervention
Maximum Oxygen Uptake (VO2 Max)
Estimated amount of oxygen uptake possible measured by the YMCA step test.
Time frame: 12 weeks after start of intervention
Total Body Strength as measured by the Isometric Mid-Thigh Pull
Quantitative test of total body strength using an instrumented dead lift technique measured in Newtons of force per kilogram of body weight.
Time frame: 12 weeks after start of intervention
Waist Circumference
a surrogate measure of visceral adiposity and one component of metabolic syndrome
Time frame: 12 weeks after start of intervention
Waist to Hip Ratio
waist circumference measurement divided by the hip circumference measurement. Ratio used to assess non-communicable disease risk
Time frame: 12 weeks after intervention start
Low-Density Lipoprotein Cholesterol (LDL-C)
diagnostic laboratory test assessing low-density lipoprotein cholesterol concentration that correlates with cardiovascular disease risk
Time frame: 12 weeks after intervention start
Blood Pressure
Measurement of arterial wall pressure and risk factor for cardiovascular disease
Time frame: 12 weeks after intervention start
Grip Strength
A simple and reliable measurement of maximum voluntary muscle strength derived from combined contraction of extrinsic and intrinsic hand muscles
Time frame: 12 weeks after intervention start
Body Weight
The mass or quantity of heaviness of an individual, expressed by units of pounds or kilograms
Time frame: 12 weeks after intervention start
Perceived Program Impact
Assessed using "Most Significant Change" tool. It is a qualitative survey tool that assesses an individual's perspective on what caused the most significant change associated with an intervention and why.
Time frame: 12 weeks after intervention start
Non High-Density Lipoprotein Cholesterol (Non-HDL-C)
measure of all atherogenic lipoproteins and cholesterol, including low-density lipoprotein (LDL) but excludes high density lipoprotein (HDL)
Time frame: 12 weeks after intervention start
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Rutgers, The State University of New Jersey