Heart DiseaseP2PNCT07380243
Pathways to Prevention Food-is-Medicine Trial
A study testing Nutrition Education, PRO-CVH and Healthy Conversation Skills in people with Heart Disease and Cardiovascular Health Status, run by Amrik Singh Khalsa at 1 site in United States.
Trial summary
The goal of this study is to learn whether combining healthy food access with personalized tools can help families improve heart health and make lasting lifestyle changes. The main questions the study aims to answer are: Do the new tools (PRO-CVH and Triple-C) help families improve their heart health? Which… Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Disease, Cardiovascular Health Status
- What is being tested?
- Nutrition Education, PRO-CVH and Healthy Conversation Skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parent or legal guardian of school-aged child (ages 6 - 11 years of age)
- Parent/legal guardian is 18 years or older and the primary caregiver at home
- Parent and/or child has an eligible Medicaid insurance plan
- Parent is able to read and speak English fluently
- Parent has BMI greater than 30 kg/m/m
- Ability to consume fruits and vegetables without concerns of any medication-nutrient interactions (for example, warfarin)
Who cannot join
- Parent not a legal guardian or the primary caregiver
- Non-English speakers
- Parent or child is diagnosed with active metabolic or digestive illnesses that may result in nutrient malabsorption (Crohn's disease, Celiac, irritable bowel syndrome, food allergies, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Amrik Khalsa, MD, (614) 722-3936, Amrik.Khalsa@nationwidechildrens.org
Colleen Spees, PhD, Colleen.Spees@osumc.edu
About this study
Official title: Health Care by Food Planning Grant
The goal of this study is to learn whether combining healthy food access with personalized tools can help families improve heart health and make lasting lifestyle changes. The main questions the study aims to answer are:
- Do the new tools (PRO-CVH and Triple-C) help families improve their heart health?
- Which combination of tools and supports works best for families with limited access to healthy food?
- Is this type of program easy to carry out and acceptable to families and healthcare teams?
Read more
Families in the study will include one parent with a BMI greater than 30 who has Medicaid insurance and their child aged 6 to 11 years.
Depending on which group they are assigned to, families may:
- Receive food and nutrition education via handouts and/or online curriculum
- Have access to an online health assessment tool than can help you understand your/your child's risk factors for heart disease
- Work with a personalized health coach who can help you set goals for healthier living online/virtually.
- Receive medically tailored groceries and cooking classes.
Researchers will follow participants for several months to see how their heart health changes and which parts of the program work best together. The information from this study will help design a larger clinical trial to test a practical, cost-effective program that can help families build healthier habits and reduce their risk of heart disease.
Read the detailed description
Heart disease is one of the leading causes of death in the United States and affects people from low-income communities at higher rates. Families with Medicaid insurance often face food insecurity, limited access to healthy foods, and other barriers that make it difficult to maintain a heart-healthy lifestyle. This study aims to address these challenges by combining nutrition support with behavioral tools that help families make and sustain healthy changes.
This study will test several "Food is Medicine" strategies that include medically tailored groceries, nutrition education, and new digital and communication tools to support healthier habits. The goal is to determine which combination of these strategies best improves heart health in parents and children.
The study will enroll families with one parent who has a body mass index (BMI) greater than 30, is enrolled in Medicaid, and has a child between 6 and 11 years old. The study focuses on this group because parents play a major role in shaping children's eating and activity habits. Supporting parents in making heart-healthy changes can improve the health of the whole family.
Participants will be assigned to different combinations of program components to see which are most effective and feasible. All families will receive some form of food and nutrition support, but each group may experience different combinations of the following components:
Food and Nutrition Education: Participants may receive educational materials or participate in an online course that covers healthy eating, cooking, and meal planning.
Online Health Assessment Tool (PRO-CVH): Families may have access to a digital tool that provides personalized feedback about heart health, based on the American Heart Association's Life's Essential 8 framework. This tool helps parents understand their current health status and identify areas for improvement.
Health Coaching: Some families will meet with a trained health coach or dietitian who can help set realistic goals, provide motivational support, and address barriers to change. Coaching will occur online or virtually.
Medically Tailored Groceries and Cooking Classes: Families may receive deliveries of heart-healthy groceries designed to support better cardiovascular health, along with cooking demonstrations to build practical food preparation skills.
The study will use a multiphase optimization design, which allows researchers to test multiple components together and identify the most effective and efficient combination. Because this is a pilot study, families will be followed for several weeks, with data collected at baseline and end of the study (4-8 weeks after enrollment).
Researchers will assess several outcomes, including:
- Changes in cardiovascular health indicators (such as blood pressure)
- Improvements in dietary patterns and readiness to change health behaviors
- Engagement with digital tools and counseling sessions
- Feasibility and acceptability of the intervention for families and healthcare teams
The information learned from this study will be used to plan a larger clinical trial. The ultimate goal is to design a scalable, cost-effective program that health systems and community organizations can use to help families build lasting heart-healthy habits.
By combining access to nutritious food with personalized tools and behavioral support, this research supports the American Heart Association's Health Care by Food initiative and its mission to reduce cardiovascular disease risk and promote longer, healthier lives.
- Conditions
- Heart Disease, Cardiovascular Health Status
- Being tested
- Nutrition Education, PRO-CVH, Healthy Conversation Skills, Medically tailored groceries/cooking classes
- Keywords
- heart disease, cardiovascular
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition EducationBehavioural
Participants will receive handouts and access to an online curriculum for nutrition education. This education will be based on the Great Garden Detective Adventure (GDA) Team Nutrition, a USDA-supported Team Nutrition program that supports the United States Department of Agriculture (USDA) MyPlate guidelines and United States Dietary Guidelines. Educational content includes: increasing fruits and vegetables, improving whole grain intake, increasing water intake and limiting sugar-sweetened and high-fat beverages, selecting lean proteins, limiting sweets, and incorporating 60 minutes of physical activity per day.
PRO-CVHBehavioural
PRO-CVH is the name of a cardiovascular health assessment and risk communication using a personalized, visual, and health-literacy friendly method. This web-based application is interactive and will assess and communicate cardiovascular health based on participant responses to surveys. The surveys will assess participant cardiovascular health indices based on the American Heart Association's Life's Essential 8 framework, behavioral components to change (e.g., motivation) and environmental barriers.
Healthy Conversation SkillsBehavioural
Healthy Conversation Skills are a behavioral intervention where health coaches and participants engage in conversations that promote change, supporting the client's autonomy in the change process, and goal-setting skills
Medically tailored groceries/cooking classesBehavioural
Participants will receive funds for an online shopping cart, which will be tailored to promote a Mediterranean diet for cardiovascular health. Participants will attend cooking classes that use these foods. Classes are a skills-based training in home-cooked meals to educate parents on creating healthy meals on a budget. The curriculum consists of weekly classes by a Land Grant Extension Specialist. Each class includes nutrition education, hands-on cooking experience, and health promoting activities.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition Education only | Active comparator | These participants will receive nutrition education only. All participants will receive nutrition education in this study, and other arms will be compared to this arm to assess the possibility that other conditions are more effective for improving cardiovascular health than education alone. Receives: Behavioral: Nutrition Education |
| Nutrition Education and Medically Tailored Groceries/Cooking Classes | Experimental | This group will receive nutrition education, medically tailored groceries, and cooking classes. Receives: Behavioral: Nutrition Education; Behavioral: Medically tailored groceries/cooking classes |
| Nutrition Education and PRO-CVH | Experimental | This arm will receive nutrition education and access to PRO-CVH, a web-based application designed to assess and communicate cardiovascular health. Receives: Behavioral: Nutrition Education; Behavioral: PRO-CVH |
| Nutrition Education and Healthy Conversational Skills | Experimental | This group will receive nutrition education and Healthy Conversational Skills, a brief behavior change counseling approach. Core principles include the clinician asking open-ended "What" and "How" questions, reflective listening, engaging in conversations that promote change, supporting the patient's autonomy in the change process, and goal-setting skills if the patient is ready Receives: Behavioral: Nutrition Education; Behavioral: Healthy Conversation Skills |
| Nutrition Education, Healthy Conversational Skills, and Medically Tailored Groceries/Cooking Classes | Experimental | Participants will receive nutrition education, Healthy Conversational Skills, medically tailored groceries, and cooking classes. Receives: Behavioral: Nutrition Education; Behavioral: Healthy Conversation Skills; Behavioral: Medically tailored groceries/cooking classes |
| Nutrition education, PRO-CVH, and medically tailored groceries/cooking classes | Experimental | This arm will receive nutrition education, access to PRO-CVH, medically tailored groceries, and cooking classes. Receives: Behavioral: Nutrition Education; Behavioral: PRO-CVH; Behavioral: Medically tailored groceries/cooking classes |
| Nutrition education, PRO-CVH, and Healthy Conversational Skills. | Experimental | Participants will receive nutrition education, access to PRO-CVH, and Healthy Conversational Skills. Receives: Behavioral: Nutrition Education; Behavioral: PRO-CVH; Behavioral: Healthy Conversation Skills |
| All Interventions | Experimental | Participants will receive nutrition education, access to PRO-CVH, Healthy Conversational Skills, medically tailored groceries, and cooking classes. Receives: Behavioral: Nutrition Education; Behavioral: PRO-CVH; Behavioral: Healthy Conversation Skills; Behavioral: Medically tailored groceries/cooking classes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Health Behavior
A questionnaire will use participant responses to short-answer questions regarding lifestyle and dietary behaviors, physical activity, sleep, biological metrics, and nicotine exposure. The responses to this standardized questionnaire will result in a single composite score.
Measured: pre-intervention and up to 8 weeks post-baseline
Intention to Change and Motivation to Change Lifestyle Behaviors
Self-reported survey to assess parent's intention to change their own and their child's lifestyle behaviors that put them at risk for future CVD.
Measured: pre-intervention and up to 8 weeks post-baseline
Program Evaluation
Survey to evaluate participant satisfaction with the intervention. The survey uses a 5-point Likert scale. There will be a series of statements and participants will select one of 5 responses ranging from 1 (completely disagree) to 5 (completely agree).
Measured: up to 8 weeks post-baseline
Qualitative Interviews
Interviews with participants to assess participant thoughts on the intervention. Interviews will be analyzed qualitatively to learn about their experience with the intervention. Focus will be given to participant satisfaction.
Measured: up to 8 weeks post-baseline
Secondary outcomes (21)
Perceived Benefits/Barriers of Change
Self-reported surveys to determine the perceived benefits and the perceived barriers to lifestyle change for themselves and their child.
Measured: pre-intervention and up to 8 weeks post-baseline
Heart Disease Knowledge
Self-reported survey to determine an individual's knowledge of heart disease for themselves.
Measured: Pre-Intervention
Adapted Risk Behavior Diagnosis (ARBD) Scale
A self-reported survey to assess perceived severity, perceived susceptibility, fear, anxiety, self-efficacy, and response efficacy with relation to parent and their perception of their child's future cardiovascular disease risk.
Measured: pre-intervention and up to 8 weeks post-baseline
Self-reported Cardiovascular Disease Risk Factors
Surveys to determine parent's and their child's CVD risk factors.
Measured: Pre-Intervention
Health Literacy
Measures to assess participant ability to understand health information. Questionnaire is a series of 5 questions about a nutritional label. Each participant response will be graded as "correct" or "incorrect" and will receive a score from 0 (no correct answers) to 5 (five correct answers).
Measured: Pre-Intervention
Healthy Conversation Skills
All Healthy Conversation Skills will be recorded. All recorded calls will be compiled and used for data collection purposes. These recordings will be used to describe participant responses to Healthy Conversation Skills communication.
Measured: Up to 8 weeks post-baseline
Childhood Opportunity Index
A measure that will map the quality of resources and conditions that matter for children to develop in a healthy way in the neighborhoods where they live.
Measured: Pre-Intervention
Social Determinants of Health
Measures of social factors that may affect an individual's health and/or ability to change their lifestyle behaviors.
Measured: pre-intervention and up to 8 weeks post-baseline
Attendance and Compliance
Attendance at all educational classes and scheduled encounters will be tracked.
Measured: pre-intervention and up to 8 weeks post-baseline
Healthcare Use
Participants will be asked a series of questions about how many times they have accessed health care facilities. Participants will respond with a number. A higher number indicates a higher healthcare use.
Measured: pre-intervention and up to 8 weeks post-baseline
Food Insecurity
Survey that asks participants a series of questions related to receiving assistance for food and difficulty accessing food. Questions about are asked as yes/no or as a 3-point Likert Scale ranging from 1 (often true) to 3 (never true).
Measured: pre-intervention and up to 8 weeks post-baseline
Dietary Screener Questionnaire (DSQ)
Dietary Screener Questionnaire (DSQ) is a brief 26-item, semi-structured food frequency questionnaire.
Measured: pre-intervention and up to 8 weeks post-baseline
Demographics
To help describe participant population, parent age, sex, race/ethnicity, level of education attainment, number of members in the household, and annual income will be recorded.
Measured: Pre-Intervention
Participant Weight
Participants will be weighed, wearing light clothing and without shoes, on a standardized and calibrated digital scale. Weight will be recorded with a precision of 0.1 kg.
Measured: pre-intervention and up to 8 weeks post-baseline
Bioelectrical Impedance
Calculation of body composition via bioelectrical impedance (e.g., InBody) which estimates free fat mass, muscle mass, fat mass and other body composition values.
Measured: pre-intervention and up to 8 weeks post-baseline
Height
Participant standing height will be measured using a standardized fixed stadiometer with a vertical backboard and moveable headboard. Care will be taken to ensure that subjects are standing with feet and chin in proper position for the height measurement. Height will be recorded to the nearest 1 mm with shoes removed.
Measured: pre-intervention and up to 8 weeks post-baseline
Body Mass Index (BMI) Percentile
BMI values are correlated with body fatness and are calculated using weight in kilograms divided by the square of height in meters. Based on the sex of the child, the correct BMI growth chart will be used. For children, the BMI percentile line closest to that point of intersection is the child's sex- and age-specific BMI percentile. For adults, BMI will be classified based on CDC criteria for normal weight, overweight, and obese.
Measured: pre-intervention and up to 8 weeks post-baseline
Waist Circumference
Waist measurements will be completed for all participants using a tape measure. Waist circumference will be measured at the uppermost lateral border of the hip crest (ilium). Waist circumference will be measured with a precision of 0.1 cm per CDC guidelines for children and adults.
Measured: pre-intervention and up to 8 weeks post-baseline
Blood Pressure
BP will be assessed by standard clinical methods using an Omron autocuff for all child and parent participants. Measurements will all be taken on the right side of the body unless the participant has a cast, amputation, or for some other reason the measurement cannot be taken on the right side.
Measured: pre-intervention and up to 8 weeks post-baseline
Blood cholesterol
Cholesterol will be calculated via point-of-care methods using the Abbott Cholestex LDX machine. Standardized protocols as per Abbott will be used to collect the sample (using a 21-gauge pinprick needle and capillary tube) to collect the sample. The LDX machine will calculate the cholesterol within 5-10 min.
Measured: pre-intervention and up to 8 weeks post-baseline
Blood glucose
3-month average glucose will be estimated via hemoglobin A1c using the Abbott Affinion machine. Standardized protocols as per Abbott will be used to collect the sample (using a 21-gauge pinprick needle and capillary tube) to collect the sample. The Affinion machine will calculate the hemoglobin A1c within a few minutes.
Measured: pre-intervention and up to 8 weeks post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start26 Feb 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amrik Singh Khalsa
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), American Heart Association, Ohio State University
- Responsible party
- Sponsor-investigator, Amrik Singh Khalsa, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380243
- Sponsor's protocol ID
- STUDY00005388
- Other IDs
- K23HL159312-04
- Acronym
- P2P
- Status last verified
- May 2026
- First submitted
- 19 Dec 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Care by Food Planning Grant
- ClinicalTrials.gov ID
- NCT07380243
- Acronym / sponsor ID
- P2P / STUDY00005388
- Conditions
- Heart Disease, Cardiovascular Health Status
- Keywords
- heart disease, cardiovascular
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Amrik Singh KhalsaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), American Heart Association, Ohio State University
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 2 Feb 2026 (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.
The goal of this study is to learn whether combining healthy food access with personalized tools can help families improve heart health and make lasting lifestyle changes. The main questions the study aims to answer are:
- Do the new tools (PRO-CVH and Triple-C) help families improve their heart health?
- Which combination of tools and supports works best for families with limited access to healthy food?
- Is this type of program easy to carry out and acceptable to families and healthcare teams?
Families in the study will include one parent with a BMI greater than 30 who has Medicaid insurance and their child aged 6 to 11 years.
Depending on which group they are assigned to, families may:
- Receive food and nutrition education via handouts and/or online curriculum
- Have access to an online health assessment tool than can help you understand your/your child's risk factors for heart disease
- Work with a personalized health coach who can help you set goals for healthier living online/virtually.
- Receive medically tailored groceries and cooking classes.
Researchers will follow participants for several months to see how their heart health changes and which parts of the program work best together. The information from this study will help design a larger clinical trial to test a practical, cost-effective program that can help families build healthier habits and reduce their risk of heart disease.
Detailed description
Heart disease is one of the leading causes of death in the United States and affects people from low-income communities at higher rates. Families with Medicaid insurance often face food insecurity, limited access to healthy foods, and other barriers that make it difficult to maintain a heart-healthy lifestyle. This study aims to address these challenges by combining nutrition support with behavioral tools that help families make and sustain healthy changes.
This study will test several "Food is Medicine" strategies that include medically tailored groceries, nutrition education, and new digital and communication tools to support healthier habits. The goal is to determine which combination of these strategies best improves heart health in parents and children.
The study will enroll families with one parent who has a body mass index (BMI) greater than 30, is enrolled in Medicaid, and has a child between 6 and 11 years old. The study focuses on this group because parents play a major role in shaping children's eating and activity habits. Supporting parents in making heart-healthy changes can improve the health of the whole family.
Participants will be assigned to different combinations of program components to see which are most effective and feasible. All families will receive some form of food and nutrition support, but each group may experience different combinations of the following components:
Food and Nutrition Education: Participants may receive educational materials or participate in an online course that covers healthy eating, cooking, and meal planning.
Online Health Assessment Tool (PRO-CVH): Families may have access to a digital tool that provides personalized feedback about heart health, based on the American Heart Association's Life's Essential 8 framework. This tool helps parents understand their current health status and identify areas for improvement.
Health Coaching: Some families will meet with a trained health coach or dietitian who can help set realistic goals, provide motivational support, and address barriers to change. Coaching will occur online or virtually.
Medically Tailored Groceries and Cooking Classes: Families may receive deliveries of heart-healthy groceries designed to support better cardiovascular health, along with cooking demonstrations to build practical food preparation skills.
The study will use a multiphase optimization design, which allows researchers to test multiple components together and identify the most effective and efficient combination. Because this is a pilot study, families will be followed for several weeks, with data collected at baseline and end of the study (4-8 weeks after enrollment).
Researchers will assess several outcomes, including:
- Changes in cardiovascular health indicators (such as blood pressure)
- Improvements in dietary patterns and readiness to change health behaviors
- Engagement with digital tools and counseling sessions
- Feasibility and acceptability of the intervention for families and healthcare teams
The information learned from this study will be used to plan a larger clinical trial. The ultimate goal is to design a scalable, cost-effective program that health systems and community organizations can use to help families build lasting heart-healthy habits.
By combining access to nutritious food with personalized tools and behavioral support, this research supports the American Heart Association's Health Care by Food initiative and its mission to reduce cardiovascular disease risk and promote longer, healthier lives.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Nutrition Education only | Active comparator | Behavioral: Nutrition EducationThese participants will receive nutrition education only. All participants will receive nutrition education in this study, and other arms will be compared to this arm to assess the possibility that other conditions are more effective for improving cardiovascular health than education alone. |
| Nutrition Education and Medically Tailored Groceries/Cooking Classes | Experimental | Behavioral: Nutrition Education, Behavioral: Medically tailored groceries/cooking classesThis group will receive nutrition education, medically tailored groceries, and cooking classes. |
| Nutrition Education and PRO-CVH | Experimental | Behavioral: Nutrition Education, Behavioral: PRO-CVHThis arm will receive nutrition education and access to PRO-CVH, a web-based application designed to assess and communicate cardiovascular health. |
| Nutrition Education and Healthy Conversational Skills | Experimental | Behavioral: Nutrition Education, Behavioral: Healthy Conversation SkillsThis group will receive nutrition education and Healthy Conversational Skills, a brief behavior change counseling approach. Core principles include the clinician asking open-ended "What" and "How" questions, reflective listening, engaging in conversations that promote change, supporting the patient's autonomy in the change process, and goal-setting skills if the patient is ready |
| Nutrition Education, Healthy Conversational Skills, and Medically Tailored Groceries/Cooking Classes | Experimental | Behavioral: Nutrition Education, Behavioral: Healthy Conversation Skills, Behavioral: Medically tailored groceries/cooking classesParticipants will receive nutrition education, Healthy Conversational Skills, medically tailored groceries, and cooking classes. |
| Nutrition education, PRO-CVH, and medically tailored groceries/cooking classes | Experimental | Behavioral: Nutrition Education, Behavioral: PRO-CVH, Behavioral: Medically tailored groceries/cooking classesThis arm will receive nutrition education, access to PRO-CVH, medically tailored groceries, and cooking classes. |
| Nutrition education, PRO-CVH, and Healthy Conversational Skills. | Experimental | Behavioral: Nutrition Education, Behavioral: PRO-CVH, Behavioral: Healthy Conversation SkillsParticipants will receive nutrition education, access to PRO-CVH, and Healthy Conversational Skills. |
| All Interventions | Experimental | Behavioral: Nutrition Education, Behavioral: PRO-CVH, Behavioral: Healthy Conversation Skills, Behavioral: Medically tailored groceries/cooking classesParticipants will receive nutrition education, access to PRO-CVH, Healthy Conversational Skills, medically tailored groceries, and cooking classes. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Parent or legal guardian of school-aged child (ages 6 - 11 years of age)
- Parent/legal guardian is 18 years or older and the primary caregiver at home
- Parent and/or child has an eligible Medicaid insurance plan
- Parent is able to read and speak English fluently
- Parent has BMI greater than 30 kg/m/m
Key exclusion criteria (3 listed)
- Parent not a legal guardian or the primary caregiver
- Non-English speakers
- Parent or child is diagnosed with active metabolic or digestive illnesses that may result in nutrient malabsorption (Crohn's disease, Celiac, irritable bowel syndrome, food allergies, etc.).
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 |
|---|---|---|
| Nutrition EducationParticipants will receive handouts and access to an online curriculum for nutrition education. This education will be based on the Great Garden Detective Adventure (GDA) Team Nutrition, a USDA-supported Team Nutrition program that supports the United States Department of Agriculture (USDA) MyPlate guidelines and United States Dietary Guidelines. Educational content includes: increasing fruits and vegetables, improving whole grain intake, increasing water intake and limiting sugar-sweetened and high-fat beverages, selecting lean proteins, limiting sweets, and incorporating 60 minutes of physical activity per day. | Behavioural | All Interventions, Nutrition Education and Healthy Conversational Skills, Nutrition Education and Medically Tailored Groceries/Cooking Classes, Nutrition Education and PRO-CVH, Nutrition Education only, Nutrition Education, Healthy Conversational Skills, and Medically Tailored Groceries/Cooking Classes, Nutrition education, PRO-CVH, and Healthy Conversational Skills., Nutrition education, PRO-CVH, and medically tailored groceries/cooking classes |
| PRO-CVHPRO-CVH is the name of a cardiovascular health assessment and risk communication using a personalized, visual, and health-literacy friendly method. This web-based application is interactive and will assess and communicate cardiovascular health based on participant responses to surveys. The surveys will assess participant cardiovascular health indices based on the American Heart Association's Life's Essential 8 framework, behavioral components to change (e.g., motivation) and environmental barriers. | Behavioural | All Interventions, Nutrition Education and PRO-CVH, Nutrition education, PRO-CVH, and Healthy Conversational Skills., Nutrition education, PRO-CVH, and medically tailored groceries/cooking classes |
| Healthy Conversation SkillsHealthy Conversation Skills are a behavioral intervention where health coaches and participants engage in conversations that promote change, supporting the client's autonomy in the change process, and goal-setting skills | Behavioural | All Interventions, Nutrition Education and Healthy Conversational Skills, Nutrition Education, Healthy Conversational Skills, and Medically Tailored Groceries/Cooking Classes, Nutrition education, PRO-CVH, and Healthy Conversational Skills. |
| Medically tailored groceries/cooking classesParticipants will receive funds for an online shopping cart, which will be tailored to promote a Mediterranean diet for cardiovascular health. Participants will attend cooking classes that use these foods. Classes are a skills-based training in home-cooked meals to educate parents on creating healthy meals on a budget. The curriculum consists of weekly classes by a Land Grant Extension Specialist. Each class includes nutrition education, hands-on cooking experience, and health promoting activities. | Behavioural | All Interventions, Nutrition Education and Medically Tailored Groceries/Cooking Classes, Nutrition Education, Healthy Conversational Skills, and Medically Tailored Groceries/Cooking Classes, Nutrition education, PRO-CVH, and medically tailored groceries/cooking classes |
Primary outcome
Cardiovascular Health Behavior
Time frame: pre-intervention and up to 8 weeks post-baseline
A questionnaire will use participant responses to short-answer questions regarding lifestyle and dietary behaviors, physical activity, sleep, biological metrics, and nicotine exposure. The responses to this standardized questionnaire will result in a single composite score.
Intention to Change and Motivation to Change Lifestyle Behaviors
Time frame: pre-intervention and up to 8 weeks post-baseline
Self-reported survey to assess parent's intention to change their own and their child's lifestyle behaviors that put them at risk for future CVD.
Program Evaluation
Time frame: up to 8 weeks post-baseline
Survey to evaluate participant satisfaction with the intervention. The survey uses a 5-point Likert scale. There will be a series of statements and participants will select one of 5 responses ranging from 1 (completely disagree) to 5 (completely agree).
Qualitative Interviews
Time frame: up to 8 weeks post-baseline
Interviews with participants to assess participant thoughts on the intervention. Interviews will be analyzed qualitatively to learn about their experience with the intervention. Focus will be given to participant satisfaction.
21 secondary outcomes
Perceived Benefits/Barriers of Change
Time frame: pre-intervention and up to 8 weeks post-baseline
Heart Disease Knowledge
Time frame: Pre-Intervention
Adapted Risk Behavior Diagnosis (ARBD) Scale
Time frame: pre-intervention and up to 8 weeks post-baseline
Self-reported Cardiovascular Disease Risk Factors
Time frame: Pre-Intervention
Health Literacy
Time frame: Pre-Intervention
Healthy Conversation Skills
Time frame: Up to 8 weeks post-baseline
Childhood Opportunity Index
Time frame: Pre-Intervention
Social Determinants of Health
Time frame: pre-intervention and up to 8 weeks post-baseline
Attendance and Compliance
Time frame: pre-intervention and up to 8 weeks post-baseline
Healthcare Use
Time frame: pre-intervention and up to 8 weeks post-baseline
Food Insecurity
Time frame: pre-intervention and up to 8 weeks post-baseline
Dietary Screener Questionnaire (DSQ)
Time frame: pre-intervention and up to 8 weeks post-baseline
Demographics
Time frame: Pre-Intervention
Participant Weight
Time frame: pre-intervention and up to 8 weeks post-baseline
Bioelectrical Impedance
Time frame: pre-intervention and up to 8 weeks post-baseline
Height
Time frame: pre-intervention and up to 8 weeks post-baseline
Body Mass Index (BMI) Percentile
Time frame: pre-intervention and up to 8 weeks post-baseline
Waist Circumference
Time frame: pre-intervention and up to 8 weeks post-baseline
Blood Pressure
Time frame: pre-intervention and up to 8 weeks post-baseline
Blood cholesterol
Time frame: pre-intervention and up to 8 weeks post-baseline
Blood glucose
Time frame: pre-intervention and up to 8 weeks post-baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition Education, PRO-CVH and Healthy Conversation Skills in people with Heart Disease and Cardiovascular Health Status, run by Amrik Singh Khalsa 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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 15 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amrik Khalsa, PhD ((614) 722-3936, Amrik.Khalsa@nationwidechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Health Behavior (time frame: pre-intervention and up to 8 weeks post-baseline). The study lists 4 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 15 May 2026.