Pathways to Prevention Food-is-Medicine Trial for Heart Health

This study, called "Pathways to Prevention Food-is-Medicine," is looking at how combining healthy food access with personalized tools can help families improve heart health and make lasting lifestyle changes. It's testing different approaches, including "Nutrition Education" (using USDA MyPlate guidelines), "PRO-CVH" (a web-based tool for understanding heart health risks), "Healthy Conversation Skills" (coaching to support healthy changes), and "Medically tailored groceries/cooking classes" (providing food and teaching how to cook Mediterranean-style meals). The study wants to see which combinations of these tools work best for families with limited access to healthy food. You might be able to join if you are a parent with a BMI (Body Mass Index) over 30, have Medicaid insurance, and have a child aged 6-11 years old. The study aims to see if these tools help improve heart health behaviors and motivation to change lifestyle habits.

Study design
This interventional study plans to enroll 120 participants. It will test different combinations of behavioral interventions to see which are most effective.
What's involved
Participants will receive handouts, access an online curriculum, use a web-based application, engage in conversations with health coaches, and attend cooking classes. Measurements will be taken before the interventions and up to 8 weeks after starting.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed up to 8 weeks post-baseline for various measurements.

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NCT07380243

Pathways to Prevention Food-is-Medicine Trial

Recruiting
NAAges 6+InterventionalPrevention
Amrik Singh Khalsa
~120 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:Nutrition EducationPRO-CVHHealthy Conversation SkillsMedically tailored groceries/cooking classes

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cardiovascular Health Behavior
Measured over pre-intervention and up to 8 weeks post-baseline
+3 more outcomes measured
Heart Disease
Cardiovascular Health Status
1 sites across 1 states
Ohio1

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Eligibility criteria

Inclusion

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)

Exclusion

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.).
  • Cardiovascular Health Behaviorpre-intervention and up to 8 weeks post-baseline

    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.

  • Intention to Change and Motivation to Change Lifestyle Behaviorspre-intervention and up to 8 weeks post-baseline

    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.

  • Program Evaluationup to 8 weeks post-baseline

    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).

  • Qualitative Interviewsup to 8 weeks post-baseline

    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.