HEART Kitchen Pilot (HEARTKITCHEN)

Reya Andrews

Status: Not yet enrolling

Conditions: Cardiovascular Diseases; Obesity and Obesity-related Medical Conditions; Type 2 Diabetes

Treatments: Behavioral: Whole Food Plant Based Diet Jumpstart

Study type: Interventional

Funder types: Other

Identifiers

NCT07037121

100837

Details and patient eligibility

About

This study is testing a 28-day healthy eating program for adults who live in public housing and are at risk for heart disease. The program helps people eat more whole plant foods, like fruits, vegetables, beans, and whole grains, and avoid foods that are highly processed or high in fat. Participants get a "kitchen makeover," including groceries, cooking tools, whole-food, plant-based recipes, and support from a nutritionist. The goal is to see if the program is easy to follow, helpful, and if support from a spouse or partner makes it easier to stick with the new way of eating.

The study will include 24 adults who either have heart disease or are at risk because of conditions like high blood pressure, diabetes, or obesity. Researchers will visit participants at home to provide supplies and support. They will also collect surveys, interviews, and health information to learn more about how the program worked and how well participants followed the diet.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult public housing residents who have been diagnosed with cardiovascular disease (Individuals who have had a documented history of myocardial infarction; Individuals who have ever had a positive stress test;, Individuals who have undergone coronary artery bypass grafting surgery at any point in their life)
• meet at least 2 of the criteria for metabolic syndrome: abdominal obesity (waist circumference of more than 35 inches for women and more than 40 inches for men or BMI = 30), high triglycerides (>150 mg/dL or drug treatment for elevated TG), low HDL cholesterol (<40 mg/dL for men and < 50 mg/dL for women or drug treatment for reduced HDL-C), high blood pressure (=130 mm Hg systolic BP, =85 mm Hg diastolic BP, or drug treatment for hypertension), high fasting blood glucose (> or = 100 mg/dL or drug treatment for elevated glucose or prediabetes/ type 2 diabetes diagnosis)
• able to provide written informed consent
• fluent in the English language

Exclusion criteria

• Active cancer or chronic kidney disease diagnosis or are undergoing cancer or dialysis treatment
• any food allergies or dietary restrictions that would prevent them from adhering to a whole-food, plant-based (WFPB) diet
• an existing or former neurological disorder or a neuropsychiatric disorder that affects decision-making ability
• current smoking
• current excessive alcohol intake
• recent history of drug abuse
• morbid obesity (BMI > 40)
• history of bariatric surgery
• pregnant or lactating
• current use of a WFPB (excludes all animal-based foods) or vegan diet

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Whole Food Plant Based (WFPB) Diet

Experimental group

Description:

28 day kitchen makeover to include initial grocery supplies, cooking equipment, recipes, and meal-prep instruction, and nutrition counseling by a licensed nutritionist, and educational support materials

Treatment:

Behavioral: Whole Food Plant Based Diet Jumpstart