Nutrition and Lifestyle Interventions for Heart Disease

(P2P Trial)

AK
Overseen ByAmrik Khalsa, PhD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Amrik Singh Khalsa
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether combining healthy food options with personalized health tools can boost heart health and support lasting lifestyle changes for families. Researchers are testing combinations such as nutrition education, tailored groceries, health coaching, and an online health assessment tool (PRO-CVH) to determine the most effective approach. It targets families where the parent has a BMI over 30 and Medicaid, and there is a child aged 6 to 11. Participants receive various supports, and researchers track changes in heart health over several months. The study aims to lay the groundwork for a larger trial to develop a practical, cost-effective program for healthier living. As an unphased trial, it offers families the chance to contribute to innovative health solutions that could enhance their well-being.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be able to consume fruits and vegetables without concerns of any medication-nutrient interactions.

Is there any evidence suggesting that this trial's interventions are likely to be safe?

Previous studies have linked providing groceries tailored to medical needs and offering cooking classes to better health outcomes. Evidence shows these programs help people consume more fruits and vegetables and feel more secure about their food situation, leading to improved health and confidence in food availability.

Research on Healthy Conversational Skills indicates that enhancing discussions about health can improve heart health. This approach engages patients in their health choices, increasing adherence to heart-healthy habits.

The PRO-CVH tool, which stands for "Cardiovascular Health," has been studied for its ability to lower heart disease risk. A higher cardiovascular health score correlates with a reduced chance of heart problems like heart attacks and strokes.

Overall, past research considers these treatments safe. They emphasize education and lifestyle changes, which generally pose fewer risks than medication or surgery.12345

Why are researchers excited about this trial?

Researchers are excited about the Nutrition and Lifestyle Interventions for Heart Disease trial because it explores a comprehensive approach to improving cardiovascular health beyond traditional medications like statins or beta-blockers. This trial uniquely combines nutrition education with medically tailored groceries, cooking classes, and Healthy Conversational Skills, potentially offering a more holistic and personalized approach to heart health. Additionally, the use of PRO-CVH, a web-based application designed to assess and communicate cardiovascular health, represents a novel digital tool that could enhance patient engagement and understanding of their condition. By integrating these diverse elements, the trial aims to uncover potentially more effective strategies for managing heart disease.

What evidence suggests that this trial's interventions could be effective for heart health?

This trial will evaluate various interventions for heart health. Research has shown that providing specially chosen groceries and cooking classes, which some participants in this trial will receive, can greatly improve diet quality and food security, both important for better heart health. Studies have found that these programs lead to healthier eating habits and may lower the risk of heart disease. Participants in other arms will receive Healthy Conversational Skills, a method of behavior change counseling that encourages open discussions about health, leading to better heart health decisions. Additionally, the PRO-CVH tool, which some participants will access, measures heart health and is linked to a lower risk of heart disease. Higher scores on this tool are associated with a reduced risk of developing heart problems. Together, these approaches have shown promise in improving heart health by supporting better lifestyle choices.36789

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.
See 3 more

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?

8

Treatment groups

Experimental Treatment

Active Control

Group I: Nutrition education, PRO-CVH, and medically tailored groceries/cooking classesExperimental Treatment3 Interventions
Group II: Nutrition education, PRO-CVH, and Healthy Conversational Skills.Experimental Treatment3 Interventions
Group III: Nutrition Education, Healthy Conversational Skills, and Medically Tailored Groceries/Cooking ClassesExperimental Treatment3 Interventions
Group IV: Nutrition Education and PRO-CVHExperimental Treatment2 Interventions
Group V: Nutrition Education and Medically Tailored Groceries/Cooking ClassesExperimental Treatment2 Interventions
Group VI: Nutrition Education and Healthy Conversational SkillsExperimental Treatment2 Interventions
Group VII: All InterventionsExperimental Treatment4 Interventions
Group VIII: Nutrition Education onlyActive Control1 Intervention

Find a Clinic Near You

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+

Citations

Effective Communication for Cardiovascular Disease Prevention

We propose a four-part model for effective shared decision making: 1) assessing patient priorities, perceived risk, and prior experience with cardiovascular ...

The effectiveness of eHealth-based cardiovascular disease ...

This study aimed to systematically review and meta-analyze the effectiveness of eHealth-based cardiovascular disease (CVD) risk ...

Cardiovascular disease risk communication

This review examines the impact of CVD risk communication on cardiovascular outcomes, exploring diverse strategies for conveying information about ...

Health Literacy in Heart Failure: A Review of the Gaps and ...

Health literacy has an essential role in heart failure (HF), contributing to medication adherence, disease self-management, and interactions ...

Effectiveness of a Hybrid Community-Based Heart-Healthy ...

Objective: This study aims to evaluate the effectiveness of a hybrid community-based approach to heart-healthy lifestyle intervention ...

Health Literacy and Cardiovascular Disease - PMC - NIH

These data indicate that health literacy strongly contributes to adverse outcomes in heart failure. Health literacy has likewise been identified as a ...

Health literacy and its role within cardiovascular disease

This commentary aims to inform health professionals about the relationship between health literacy and cardiovascular outcomes.

Role of Technology in Promoting Heart Healthy Behavior ...

In this scientific statement, we examined the technology-enabled interventions that address cardiovascular health behaviors from adolescence to adulthood.

a qualitative study on healthcare professionals' and patients ...

HL is defined as “people's knowledge, motivation and competences to access, understand, appraise, and apply health information” [2].