Nutrition and Lifestyle Interventions for Heart Disease

(P2P Trial)

Overseen By Amrik Khalsa, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Amrik Singh Khalsa

Must not be taking: Warfarin

Disqualifiers: Metabolic, Digestive illnesses, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for families with one parent having a BMI over 30 and Medicaid insurance, plus their child aged 6-11. It's designed to help those with limited access to healthy food improve heart health through various tools and supports.

Inclusion Criteria

I can eat fruits and vegetables without affecting my medications.

I am the parent or guardian of a child aged 6-11.

I am over 18 and the main caregiver for the patient at home.

Exclusion Criteria

Parent not a legal guardian or the primary caregiver

Non-English speakers

I or my child have a condition like Crohn's, Celiac, or IBS that affects how we absorb nutrients.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive various combinations of nutrition education, medically tailored groceries, cooking classes, health coaching, and access to digital health assessment tools.

4-8 weeks

Multiple virtual and in-person sessions

Follow-up

Participants are monitored for changes in cardiovascular health indicators and engagement with the program components.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Healthy Conversation Skills
• Medically tailored groceries/cooking classes
• PRO-CVH

Trial Overview

The study tests if combining medically tailored groceries, cooking classes, nutrition education, an online health assessment tool (PRO-CVH), and personalized coaching can enhance cardiovascular health in families.

How Is the Trial Designed?

Group I: Nutrition education, PRO-CVH, and medically tailored groceries/cooking classes Experimental Treatment 3 Interventions

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

Group II: Nutrition education, PRO-CVH, and Healthy Conversational Skills. Experimental Treatment 3 Interventions

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

Group III: Nutrition Education, Healthy Conversational Skills, and Medically Tailored Groceries/Cooking Classes Experimental Treatment 3 Interventions

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

Group IV: Nutrition Education and PRO-CVH Experimental Treatment 2 Interventions

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

Group V: Nutrition Education and Medically Tailored Groceries/Cooking Classes Experimental Treatment 2 Interventions

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

Group VI: Nutrition Education and Healthy Conversational Skills Experimental Treatment 2 Interventions

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

Group VII: All Interventions Experimental Treatment 4 Interventions

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

Group VIII: Nutrition Education only Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Amrik Singh Khalsa

Lead Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+