Who is eligible for clinical trial NCT07380243?

Participants must meet protocol criteria for Heart Disease. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07380243 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-05-13

Pathways to Prevention Food-is-Medicine Trial (NCT07380243)

🟢 Recruiting Observational / Diagnostic 🧠 Behavioral & Psychological Program Sponsor: Amrik Singh Khalsa

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (4 items).

Location: Nationwide Children's Hospital — Columbus, Ohio

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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)

Usually NOT eligible if any of the following apply:

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.).

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Nationwide Children's Hospital — Columbus, Ohio

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗