NCT07380243

Pathways to Prevention Food-is-Medicine Trial

Health Care by Food Planning Grant

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Amrik Singh Khalsa · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Accepted

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.

Detailed description

Heart disease is one of the leading causes of death in the United States and affects people from low-income communities at higher rates. Families with Medicaid insurance often face food insecurity, limited access to healthy foods, and other barriers that make it difficult to maintain a heart-healthy lifestyle. This study aims to address these challenges by combining nutrition support with behavioral tools that help families make and sustain healthy changes. This study will test several "Food is Medicine" strategies that include medically tailored groceries, nutrition education, and new digital and communication tools to support healthier habits. The goal is to determine which combination of these strategies best improves heart health in parents and children. The study will enroll families with one parent who has a body mass index (BMI) greater than 30, is enrolled in Medicaid, and has a child between 6 and 11 years old. The study focuses on this group because parents play a major role in shaping children's eating and activity habits. Supporting parents in making heart-healthy changes can improve the health of the whole family. Participants will be assigned to different combinations of program components to see which are most effective and feasible. All families will receive some form of food and nutrition support, but each group may experience different combinations of the following components: Food and Nutrition Education: Participants may receive educational materials or participate in an online course that covers healthy eating, cooking, and meal planning. Online Health Assessment Tool (PRO-CVH): Families may have access to a digital tool that provides personalized feedback about heart health, based on the American Heart Association's Life's Essential 8 framework. This tool helps parents understand their current health status and identify areas for improvement. Health Coaching: Some families will meet with a trained health coach or dietitian who can help set realistic goals, provide motivational support, and address barriers to change. Coaching will occur online or virtually. Medically Tailored Groceries and Cooking Classes: Families may receive deliveries of heart-healthy groceries designed to support better cardiovascular health, along with cooking demonstrations to build practical food preparation skills. The study will use a multiphase optimization design, which allows researchers to test multiple components together and identify the most effective and efficient combination. Because this is a pilot study, families will be followed for several weeks, with data collected at baseline and end of the study (4-8 weeks after enrollment). Researchers will assess several outcomes, including: * Changes in cardiovascular health indicators (such as blood pressure) * Improvements in dietary patterns and readiness to change health behaviors * Engagement with digital tools and counseling sessions * Feasibility and acceptability of the intervention for families and healthcare teams The information learned from this study will be used to plan a larger clinical trial. The ultimate goal is to design a scalable, cost-effective program that health systems and community organizations can use to help families build lasting heart-healthy habits. By combining access to nutritious food with personalized tools and behavioral support, this research supports the American Heart Association's Health Care by Food initiative and its mission to reduce cardiovascular disease risk and promote longer, healthier lives.

Conditions

• Heart Disease
• Cardiovascular Health Status

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2026-02-02
• Last updated: 2026-02-02

Locations

1 site across 1 country: United States