HEART Kitchen Pilot

NCT07037121 | Withdrawn

• 1 other identifier: 100837
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Whole-Food Plant-Based Diet; Cardiovascular Disease; Health Disparities; Feasibility Study; Public Housing; Spousal Support; Low-Income Adults; Diet Adherence; Nutrition Intervention; Kitchen Makeover

Outcome Measures

Primary Outcomes (8)

• Change in adherence to the whole-food, plant-based (WFPB) diet (pre-post) based on ACLM diet screener.

  Dietary intake will be assessed using the American College of Lifestyle Medicine (ACLM) Diet Screener at baseline (Day 0) and post-intervention (Day 29). This validated 15-item tool measures frequency of consumption of foods consistent with a whole-food, plant-based (WFPB) diet. Total scores range from 0 to 100, with higher scores indicating greater adherence to a WFPB diet. Change in dietary intake will be calculated by subtracting the baseline score from the post-intervention score. Positive values reflect improvement in WFPB dietary adherence.

  Baseline and post intervention (week 4)

• Change in weight

  Weightwill be measured using the Runstar Scale for Body Weight and Fat Percentage, 8 Electrodes High Precision Digital Scale

  Baseline and week 4

• Change in Body Mass Index

  BMI in kg/m\^2 based on measured weight in kg and height in meters.

  Baseline and week 4

• Change in fat mass

  Fat mass will be measured using the Runstar Scale for Body Weight and Fat Percentage, 8 Electrodes High Precision Digital Scale

  Baseline and week 4

• Change in systolic blood pressure.

  Blood pressure will be measured using the Oklar Blood Pressure Monitors for Home Use Rechargeable Blood Pressure Cuff Wrist Digital BP Machine

  Baseline and week 4

• Change in lean mass

  Lean mass will be measured using the Runstar Scale for Body Weight and Fat Percentage, 8 Electrodes High Precision Digital Scale

  Baseline and week 4

• Change in diastolic blood pressure.

  Blood pressure will be measured using the Oklar Blood Pressure Monitors for Home Use Rechargeable Blood Pressure Cuff Wrist Digital BP Machine

  Baseline and week 4

• WFPB diet acceptability

  At Day 29, participants will complete a Likert-scale survey evaluating the acceptability of the intervention, including satisfaction with meal prep, support sessions, and educational materials. Each item will be rated on a 5-point scale (1 = strongly disagree to 5 = strongly agree). Higher average scores reflect greater acceptability.

  Post- intervention (day 29)

Secondary Outcomes (2)

• Qualitative Assessment of Spousal Influence on Diet Adherence (Exit Interview Coding)

  Baseline, post intervention week 4

• Difference in WFPB Diet Adherence Between Spousal Dyads and Single Individuals

  Pre/Post (baseline and 4 weeks)

Study Arms (1)

Whole Food Plant Based (WFPB) Diet

EXPERIMENTAL

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

Behavioral: Whole Food Plant Based Diet Jumpstart

Interventions

Whole Food Plant Based Diet Jumpstart 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.

Whole Food Plant Based (WFPB) Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Reya Andrews: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Brandi White, PhD

  University of Kentucky

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 25, 2025
• Study Start: September 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)