Food is Medicine vs Lifestyle Medicine For Cardiovascular Kidney Metabolic (CKM) Syndrome
NCT Number: NCT06461273
Acronym: FiLMED
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Mellitus|Metabolic Syndrome|Obesity|Hypertension,Essential|Hyperlipidemias|Cardiovascular Diseases|Kidney Disease, Chronic
Interventions: BEHAVIORAL: Lifestyle Medicine Program|BEHAVIORAL: Medically Tailored Groceries
Sponsor: Rutgers, The State University of New Jersey
Collaborators: Ethos Farm to Health
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-22
Completion Date: 2025-06-30
Locations: Rutgers Health New Jersey Family Practice Center, Newark, New Jersey, 07103, United States

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).

Primary Outcome Measures: 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 Outcome Measures: Food Security, Defined as access by all members, at all times to have enough food for an active, healthy life, 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, 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., 12 weeks after start of intervention|Physical Activity, Self-reported and measured duration and intensity of physical activity, 12 weeks after start of intervention
Other Outcome Measures: Hemoglobin A1C, Measure of glycosylated hemoglobin and diagnostic test for diabetes, 12 weeks after start of intervention|Maximum Oxygen Uptake (VO2 Max), Estimated amount of oxygen uptake possible measured by the YMCA step test., 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., 12 weeks after start of intervention|Waist Circumference, a surrogate measure of visceral adiposity and one component of metabolic syndrome, 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, 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, 12 weeks after intervention start|Blood Pressure, Measurement of arterial wall pressure and risk factor for cardiovascular disease, 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, 12 weeks after intervention start|Body Weight, The mass or quantity of heaviness of an individual, expressed by units of pounds or kilograms, 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., 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), 12 weeks after intervention start