Cardiovascular DiseasesHEARTKITCHENNCT07037121
HEART Kitchen Pilot
A study testing Whole Food Plant Based Diet Jumpstart in people with Cardiovascular Diseases and Type 2 Diabetes, run by Reya Andrews at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Type 2 Diabetes, Obesity and Obesity-related Medical Conditions
- What is being tested?
- Whole Food Plant Based Diet Jumpstart
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2025to Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Healthy Eating Adherence & Routine Transformation Through a Kitchen Makeover Whole-Food, Plant-Based Diet Jumpstart (HEARTKITCHEN)
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.
- Being tested
- Whole Food Plant Based Diet Jumpstart
- 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
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Food Plant Based Diet JumpstartBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Whole Food Plant Based Diet Jumpstart |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Baseline and week 4
Change in Body Mass Index
BMI in kg/m^2 based on measured weight in kg and height in meters.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Post- intervention (day 29)
Secondary outcomes (2)
Qualitative Assessment of Spousal Influence on Diet Adherence (Exit Interview Coding)
Exit interviews will be conducted with a subset of participants in dyads to assess how spousal involvement influenced WFPB diet adherence. Interviews will be transcribed and analyzed thematically. Themes will be identified using qualitative coding methods to evaluate facilitators and barriers related to spousal support. The presence or absence of key support behaviors (e.g., shared cooking, encouragement, resistance) will be documented.
Measured: Baseline, post intervention week 4
Difference in WFPB Diet Adherence Between Spousal Dyads and Single Individuals
Adherence to a whole-food, plant-based (WFPB) diet will be measured using the ACLM Diet Screener at baseline (Day 0) and post-intervention (Day 29), with scores ranging from 0 to 100. Higher scores indicate greater adherence. The change in diet screener scores will be compared between participants enrolled as part of a spousal dyad and those enrolled as individuals to assess whether spousal participation is associated with greater adherence to the WFPB diet.
Measured: Pre/Post (baseline and 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study startSep 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Why it stopped: PI leaving
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reya Andrews
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Reya Andrews, University of Kentucky
- Investigators
- Brandi White, PhD, Study chair, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037121
- Sponsor's protocol ID
- 100837
- Acronym
- HEARTKITCHEN
- Status last verified
- Aug 2025
- First submitted
- 16 Jun 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Eating Adherence & Routine Transformation Through a Kitchen Makeover Whole-Food, Plant-Based Diet Jumpstart (HEARTKITCHEN)
- ClinicalTrials.gov ID
- NCT07037121
- Acronym / sponsor ID
- HEARTKITCHEN / 100837
- Keywords
- Whole-Food Plant-Based Diet, Cardiovascular Disease, Health Disparities, Feasibility Study, Public Housing, Spousal Support, Low-Income Adults, Diet Adherence
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI leaving
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Reya AndrewsUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Whole Food Plant Based (WFPB) Diet | Experimental | Behavioral: Whole Food Plant Based Diet Jumpstart28 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Food Plant Based Diet JumpstartParticipants 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. | Behavioural | Whole Food Plant Based (WFPB) Diet |
Primary outcome
Change in adherence to the whole-food, plant-based (WFPB) diet (pre-post) based on ACLM diet screener.
Time frame: Baseline and post intervention (week 4)
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.
Change in weight
Time frame: Baseline and week 4
Weightwill be measured using the Runstar Scale for Body Weight and Fat Percentage, 8 Electrodes High Precision Digital Scale
Change in Body Mass Index
Time frame: Baseline and week 4
BMI in kg/m^2 based on measured weight in kg and height in meters.
Change in fat mass
Time frame: Baseline and week 4
Fat mass will be measured using the Runstar Scale for Body Weight and Fat Percentage, 8 Electrodes High Precision Digital Scale
Change in systolic blood pressure.
Time frame: Baseline and week 4
Blood pressure will be measured using the Oklar Blood Pressure Monitors for Home Use Rechargeable Blood Pressure Cuff Wrist Digital BP Machine
Change in lean mass
Time frame: Baseline and week 4
Lean mass will be measured using the Runstar Scale for Body Weight and Fat Percentage, 8 Electrodes High Precision Digital Scale
Change in diastolic blood pressure.
Time frame: Baseline and week 4
Blood pressure will be measured using the Oklar Blood Pressure Monitors for Home Use Rechargeable Blood Pressure Cuff Wrist Digital BP Machine
WFPB diet acceptability
Time frame: Post- intervention (day 29)
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.
2 secondary outcomes
Qualitative Assessment of Spousal Influence on Diet Adherence (Exit Interview Coding)
Time frame: Baseline, post intervention week 4
Difference in WFPB Diet Adherence Between Spousal Dyads and Single Individuals
Time frame: Pre/Post (baseline and 4 weeks)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brandi White, PhD study chair
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Food Plant Based Diet Jumpstart in people with Cardiovascular Diseases and Type 2 Diabetes, run by Reya Andrews at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in adherence to the whole-food, plant-based (WFPB) diet (pre-post) based on ACLM diet screener. (time frame: Baseline and post intervention (week 4)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.