Nutrition and Lifestyle Interventions for Heart Disease
(P2P Trial)
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.12345Why 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive various combinations of nutrition education, medically tailored groceries, cooking classes, health coaching, and access to digital health assessment tools.
Follow-up
Participants are monitored for changes in cardiovascular health indicators and engagement with the program components.
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
This arm will receive nutrition education, access to PRO-CVH, medically tailored groceries, and cooking classes.
Participants will receive nutrition education, access to PRO-CVH, and Healthy Conversational Skills.
Participants will receive nutrition education, Healthy Conversational Skills, medically tailored groceries, and cooking classes.
This arm will receive nutrition education and access to PRO-CVH, a web-based application designed to assess and communicate cardiovascular health.
This group will receive nutrition education, medically tailored groceries, and cooking classes.
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
Participants will receive nutrition education, access to PRO-CVH, Healthy Conversational Skills, medically tailored groceries, and cooking classes.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amrik Singh Khalsa
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
American Heart Association
Collaborator
Ohio State University
Collaborator
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].
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