Pathways to Prevention Food-is-Medicine Trial
P2P
Health Care by Food Planning Grant
2 other identifiers
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2025
CompletedFirst Posted
Study publicly available on registry
February 2, 2026
CompletedStudy Start
First participant enrolled
February 26, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
May 15, 2026
May 1, 2026
9 months
December 19, 2025
May 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Cardiovascular Health Behavior
A questionnaire will use participant responses to short-answer questions regarding lifestyle and dietary behaviors, physical activity, sleep, biological metrics, and nicotine exposure. The responses to this standardized questionnaire will result in a single composite score.
pre-intervention and up to 8 weeks post-baseline
Intention to Change and Motivation to Change Lifestyle Behaviors
Self-reported survey to assess parent's intention to change their own and their child's lifestyle behaviors that put them at risk for future CVD.
pre-intervention and up to 8 weeks post-baseline
Program Evaluation
Survey to evaluate participant satisfaction with the intervention. The survey uses a 5-point Likert scale. There will be a series of statements and participants will select one of 5 responses ranging from 1 (completely disagree) to 5 (completely agree).
up to 8 weeks post-baseline
Qualitative Interviews
Interviews with participants to assess participant thoughts on the intervention. Interviews will be analyzed qualitatively to learn about their experience with the intervention. Focus will be given to participant satisfaction.
up to 8 weeks post-baseline
Secondary Outcomes (21)
Perceived Benefits/Barriers of Change
pre-intervention and up to 8 weeks post-baseline
Heart Disease Knowledge
Pre-Intervention
Adapted Risk Behavior Diagnosis (ARBD) Scale
pre-intervention and up to 8 weeks post-baseline
Self-reported Cardiovascular Disease Risk Factors
Pre-Intervention
Health Literacy
Pre-Intervention
- +16 more secondary outcomes
Study Arms (8)
Nutrition Education only
ACTIVE COMPARATORThese 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.
Nutrition Education and Medically Tailored Groceries/Cooking Classes
EXPERIMENTALThis group will receive nutrition education, medically tailored groceries, and cooking classes.
Nutrition Education and PRO-CVH
EXPERIMENTALThis arm will receive nutrition education and access to PRO-CVH, a web-based application designed to assess and communicate cardiovascular health.
Nutrition Education and Healthy Conversational Skills
EXPERIMENTALThis 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
Nutrition Education, Healthy Conversational Skills, and Medically Tailored Groceries/Cooking Classes
EXPERIMENTALParticipants will receive nutrition education, Healthy Conversational Skills, medically tailored groceries, and cooking classes.
Nutrition education, PRO-CVH, and medically tailored groceries/cooking classes
EXPERIMENTALThis arm will receive nutrition education, access to PRO-CVH, medically tailored groceries, and cooking classes.
Nutrition education, PRO-CVH, and Healthy Conversational Skills.
EXPERIMENTALParticipants will receive nutrition education, access to PRO-CVH, and Healthy Conversational Skills.
All Interventions
EXPERIMENTALParticipants will receive nutrition education, access to PRO-CVH, Healthy Conversational Skills, medically tailored groceries, and cooking classes.
Interventions
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.
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.
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
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.
Eligibility Criteria
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.).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amrik Singh Khalsalead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- American Heart Associationcollaborator
- Ohio State Universitycollaborator
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Research coordinators who will be taking measurements from participants will be blinded.
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 19, 2025
First Posted
February 2, 2026
Study Start
February 26, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
May 15, 2026
Record last verified: 2026-05