Pathways to Prevention Food-is-Medicine 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 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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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

BEHAVIORAL

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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• American Heart Association

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• Amrik Singh Khalsa

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

6 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-02-26

Primary Completion

2026-12-01

Completion

2026-12-01

Countries

• United States

Study Locations