Pathways to Prevention Food-is-Medicine Trial

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.

NCT Number	NCT07380243
Lead Sponsor	Amrik Singh Khalsa Collaborators: National Heart, Lung, and Blood Institute (NHLBI), American Heart Association, Ohio State University
Conditions	Heart Disease, Cardiovascular Health Status
Enrollment	120 participants
Start Date	2026-02-26
Primary Completion	2026-12-01 (estimated)
Study Completion	2026-12-01 (estimated)
Updated on ClinicalTrials.gov	2026-05-15