Pathways to Prevention Food-is-Medicine Trial

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Amrik Singh Khalsa
Study ID
NCT07380243
Status
Recruiting
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Conditions

  • Cardiovascular Health Status
  • Heart Disease

Eligibility Criteria

Sex
ALL
Age
6 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Nutrition Education — BEHAVIORAL
    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.
  • PRO-CVH — BEHAVIORAL
    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.
  • Healthy Conversation Skills — BEHAVIORAL
    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
  • Medically tailored groceries/cooking classes — BEHAVIORAL
    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.

Study Details

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 Dates

Start date
Feb 26, 2026
Status verified
May 2026
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Nutrition Education only
    These participants will receive nutrition education only. All participants will receive nutrition education in this study, and other arms will be compared to this arm to assess the possibility that other conditions are more effective for improving cardiovascular health than education alone.
  • Experimental: Nutrition Education and Medically Tailored Groceries/Cooking Classes
    This group will receive nutrition education, medically tailored groceries, and cooking classes.
  • Experimental: Nutrition Education and PRO-CVH
    This arm will receive nutrition education and access to PRO-CVH, a web-based application designed to assess and communicate cardiovascular health.
  • Experimental: Nutrition Education and Healthy Conversational Skills
    This group will receive nutrition education and Healthy Conversational Skills, a brief behavior change counseling approach. Core principles include the clinician asking open-ended "What" and "How" questions, reflective listening, engaging in conversations that promote change, supporting the patient's autonomy in the change process, and goal-setting skills if the patient is ready
  • Experimental: Nutrition Education, Healthy Conversational Skills, and Medically Tailored Groceries/Cooking Classes
    Participants will receive nutrition education, Healthy Conversational Skills, medically tailored groceries, and cooking classes.
  • Experimental: Nutrition education, PRO-CVH, and medically tailored groceries/cooking classes
    This arm will receive nutrition education, access to PRO-CVH, medically tailored groceries, and cooking classes.
  • Experimental: Nutrition education, PRO-CVH, and Healthy Conversational Skills.
    Participants will receive nutrition education, access to PRO-CVH, and Healthy Conversational Skills.
  • Experimental: All Interventions
    Participants will receive nutrition education, access to PRO-CVH, Healthy Conversational Skills, medically tailored groceries, and cooking classes.

Primary Outcome Measure

Cardiovascular Health Behavior [ Time Frame: pre-intervention and up to 8 weeks post-baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nationwide Children's HospitalColumbusOhio43205
Amrik Khalsa, MD
[email protected]
(614) 722-3936
Colleen Spees, PhD
[email protected]
Amrik Khalsa, MD (PRINCIPAL_INVESTIGATOR)

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