Pathways to Prevention Food-is-Medicine Trial

Recruiting now · Not applicable

Conditions studied: Heart Disease, Cardiovascular Health Status

In brief

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.

Key facts

Study ID

NCT07380243

Run by

Amrik Singh Khalsa

People needed

120

Starts

2026-02-26

Expected to finish

2026-12-01

Last updated by the study team

2026-05-15

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.).

Where it is running

• Nationwide Children's Hospital — Columbus, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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