Recruiting

Heart Health Program

Sponsor:

Amrik Singh Khalsa

Code:

NCT07380243

Conditions

Heart Disease

Cardiovascular Health Status

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Accepted

Interventions

Nutrition Education

PRO-CVH

Healthy Conversation Skills

Medically tailored groceries/cooking classes

Study Details

Brief 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 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.

Conditions

Heart Disease

Cardiovascular Health Status

Study ID

NCT07380243

Start date

Feb 26, 2026

Status verified date

May, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.).

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Nutrition Education only

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.

experimental: Nutrition Education and Medically Tailored Groceries/Cooking Classes

This group will receive nutrition education, medically tailored groceries, and cooking classes.

experimental: Nutrition Education and PRO-CVH

This arm will receive nutrition education and access to PRO-CVH, a web-based application designed to assess and communicate cardiovascular health.

experimental: Nutrition Education and Healthy Conversational Skills

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

experimental: Nutrition Education, Healthy Conversational Skills, and Medically Tailored Groceries/Cooking Classes

Participants will receive nutrition education, Healthy Conversational Skills, medically tailored groceries, and cooking classes.

experimental: Nutrition education, PRO-CVH, and medically tailored groceries/cooking classes

This arm will receive nutrition education, access to PRO-CVH, medically tailored groceries, and cooking classes.

experimental: Nutrition education, PRO-CVH, and Healthy Conversational Skills.

Participants will receive nutrition education, access to PRO-CVH, and Healthy Conversational Skills.

experimental: All Interventions

Participants will receive nutrition education, access to PRO-CVH, Healthy Conversational Skills, medically tailored groceries, and cooking classes.

Interventions

Nutrition Education

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-CVH

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 Skills

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 classes

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.

Primary outcome measure

  • Cardiovascular Health Behavior [ Time Frame: pre-intervention and up to 8 weeks post-baseline ]
  • Intention to Change and Motivation to Change Lifestyle Behaviors [ Time Frame: pre-intervention and up to 8 weeks post-baseline ]
  • Program Evaluation [ Time Frame: up to 8 weeks post-baseline ]
  • Qualitative Interviews [ Time Frame: up to 8 weeks post-baseline ]

Central Contacts and Locations

Central contacts

Amrik Khalsa, PhD

(614) 722-3936Amrik.Khalsa@nationwidechildrens.org

Locations

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Amrik Khalsa, MD

(614) 722-3936Amrik.Khalsa@nationwidechildrens.org

Colleen Spees, PhD

Colleen.Spees@osumc.edu

Principal Investigator:

Amrik Khalsa, MD

More Information

Sponsor

Amrik Singh Khalsa

Last update posted

May 15, 2026

Last verified

May, 2026

Keywords

  • heart disease
  • cardiovascular

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Amrik Singh Khalsa on 2026-05-15.