Pathways to Prevention Food-is-Medicine Trial (P2P)

Amrik Singh Khalsa

Status: Not yet enrolling

Conditions: Cardiovascular Health Status; Heart Disease

Treatments: Behavioral: Nutrition Education; Behavioral: PRO-CVH; Behavioral: Medically tailored groceries/cooking classes; Behavioral: Healthy Conversation Skills

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07380243

STUDY00005388

K23HL159312-04 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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120 participants in 8 patient groups

Nutrition Education only

Active Comparator group

Description:

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.

Treatment:

Behavioral: Nutrition Education

Nutrition Education and Medically Tailored Groceries/Cooking Classes

Experimental group

Description:

This group will receive nutrition education, medically tailored groceries, and cooking classes.

Treatment:

Behavioral: Medically tailored groceries/cooking classes

Behavioral: Nutrition Education

Nutrition Education and PRO-CVH

Experimental group

Description:

This arm will receive nutrition education and access to PRO-CVH, a web-based application designed to assess and communicate cardiovascular health.

Treatment:

Behavioral: PRO-CVH

Behavioral: Nutrition Education

Nutrition Education and Healthy Conversational Skills

Experimental group

Description:

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

Treatment:

Behavioral: Healthy Conversation Skills

Behavioral: Nutrition Education

Nutrition Education, Healthy Conversational Skills, and Medically Tailored Groceries/Cooking Classes

Experimental group

Description:

Participants will receive nutrition education, Healthy Conversational Skills, medically tailored groceries, and cooking classes.

Treatment:

Behavioral: Medically tailored groceries/cooking classes

Behavioral: Healthy Conversation Skills

Behavioral: Nutrition Education

Nutrition education, PRO-CVH, and medically tailored groceries/cooking classes

Experimental group

Description:

This arm will receive nutrition education, access to PRO-CVH, medically tailored groceries, and cooking classes.

Treatment:

Behavioral: Medically tailored groceries/cooking classes

Behavioral: PRO-CVH

Behavioral: Nutrition Education

Nutrition education, PRO-CVH, and Healthy Conversational Skills.

Experimental group

Description:

Participants will receive nutrition education, access to PRO-CVH, and Healthy Conversational Skills.

Treatment:

Behavioral: Healthy Conversation Skills

Behavioral: PRO-CVH

Behavioral: Nutrition Education

All Interventions

Experimental group

Description:

Participants will receive nutrition education, access to PRO-CVH, Healthy Conversational Skills, medically tailored groceries, and cooking classes.

Treatment:

Behavioral: Medically tailored groceries/cooking classes

Behavioral: Healthy Conversation Skills

Behavioral: PRO-CVH

Behavioral: Nutrition Education