HEART Kitchen Pilot

NCT ID: NCT07037121

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2025-11-30

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Whole Food Plant Based (WFPB) Diet

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

Group Type: EXPERIMENTAL

Whole Food Plant Based Diet Jumpstart

Intervention Type: BEHAVIORAL

Participants receive personally-tailored support by a research nutritionist during five total visits: (1)baseline visit to collect surveys on health status, current home kitchen-based habits, kitchen inventory, food preferences, and clinical measures, followed by assessing health goals, obstacles, and opportunities. At least two breakfast, three lunch, and five dinner WFPB recipes will be selected. (2) A kitchen-centered visit will target the fridge, pantries, and cabinets to assist participants in cleaning out ultra-processed "junk" foods. These foods will be stored in a large tote during the study. (3) The day before the intervention starts will be a grocery shopping trip to purchase the WFPB heart-healthy groceries together. (4) Intervention day 1 will focus on jumpstarting meal prep. After day 1, weekly 30-min telehealth nutrition consultations will provide additional support. (5) Clinical measures and postintervention surveys will be collected on day 29.

Interventions

Whole Food Plant Based Diet Jumpstart

Participants receive personally-tailored support by a research nutritionist during five total visits: (1)baseline visit to collect surveys on health status, current home kitchen-based habits, kitchen inventory, food preferences, and clinical measures, followed by assessing health goals, obstacles, and opportunities. At least two breakfast, three lunch, and five dinner WFPB recipes will be selected. (2) A kitchen-centered visit will target the fridge, pantries, and cabinets to assist participants in cleaning out ultra-processed "junk" foods. These foods will be stored in a large tote during the study. (3) The day before the intervention starts will be a grocery shopping trip to purchase the WFPB heart-healthy groceries together. (4) Intervention day 1 will focus on jumpstarting meal prep. After day 1, weekly 30-min telehealth nutrition consultations will provide additional support. (5) Clinical measures and postintervention surveys will be collected on day 29.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Reya Andrews

OTHER

Sponsor Role: lead

Responsible Party

Reya Andrews

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Brandi White, PhD

Role: STUDY_CHAIR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

100837

Identifier Type: -

Identifier Source: org_study_id