Digital Health Tool for Cardiovascular Health and Obesity

Recruiting at 2 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Urban residence, High income, others

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

Compensation: Varies

Number of Visits: 7

Duration: 6 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital tool called PREVENT, designed to help people with obesity in rural areas improve heart health. It targets low-income patients who may lack easy access to resources for healthy eating and exercise. The tool uses personal and electronic health data to provide tailored advice and resources during clinic visits. Participants with a BMI of 30 or more who receive care from the Missouri Highlands may be suitable for this trial. As an unphased trial, it offers a unique opportunity to access innovative resources that could significantly enhance heart health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the PREVENT tool is safe for use in healthcare settings?

Research has shown that digital health tools like PREVENT can significantly enhance healthcare for conditions such as heart disease and obesity. These tools are safe and easy to use because they rely on technology to manage health, rather than introducing new drugs or treatments.

Studies have found that digital health solutions offer better ways to manage conditions, often presenting fewer risks compared to traditional treatments. No major reports of negative effects have emerged from using digital health tools, as they primarily assist with communication and tracking health information.

PREVENT helps doctors provide personalized advice based on each person's health data. This makes it a supportive tool rather than a direct treatment, ensuring it is very safe and easy for patients to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Digital Health Tool for Cardiovascular Health and Obesity because it offers a personalized, supportive approach to managing these conditions. Unlike standard treatments that might include medication or generic lifestyle advice, this tool leverages a tailored behavior change plan delivered by a community health worker. This plan is individualized, considering each patient's unique needs and providing ongoing support for six months. Additionally, the integration of community resources and personalized goal-setting helps address social determinants of health, which are often overlooked in traditional care. This innovative approach aims to empower patients and potentially lead to more sustainable health improvements.

What evidence suggests that the PREVENT tool is effective for improving cardiovascular health and managing obesity?

In this trial, participants will either receive the PREVENT intervention or join a wait-list control group. A previous study showed that using an online tool for heart health led to fewer heart problems. Specifically, 15.7% of participants saw improvements compared to just 4.6% who did not use the tool. The PREVENT tool, which participants in this trial may use, helps doctors utilize patient information to suggest lifestyle changes, such as diet and exercise, which are important for heart health. Research has shown that digital health tools like PREVENT can help lower blood pressure, improve fitness, manage weight, and balance cholesterol levels. These improvements are key to reducing the risk of heart disease. By focusing on these areas, PREVENT aims to support better heart health, especially for people facing challenges like obesity or living in rural areas. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for low-income adults aged 18-64 living in rural areas, who are patients at Missouri Highlands with a BMI of 30 or higher. They must understand and agree to sign an informed consent form.

Inclusion Criteria

Low-income (household income <200% poverty)

Receiving care from the Missouri Highlands

Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete questionnaires at baseline, administered electronically or by mail

1 week

1 visit (virtual or mail)

Treatment

Participants receive the PREVENT intervention, including a tailored behavioral change plan and ongoing support for 6 months

6 months

Monthly follow-ups (virtual or mail)

Follow-up

Participants are monitored for changes in cardiovascular health and behavior outcomes

6 months

Follow-up measures immediately after clinic visit and at 6 months

What Are the Treatments Tested in This Trial?

Interventions

• PREVENT

Trial Overview

The PREVENT digital health tool is being tested. It helps healthcare teams provide personalized counseling on healthy eating and physical activity during clinic visits to improve cardiovascular health among rural patients.

How Is the Trial Designed?

Group I: PREVENT Intervention Experimental Treatment 1 Intervention

Complete questionnaires at baseline (administered electronically or by mail). Follow-up measures will be administered immediately following the clinic visit, and monthly for 6-months after the clinic visit electronically and by mail At the clinic visit, the provider will use the PREVENT tool to discuss CVH risk. A community health worker (CHW) will deliver a tailored behavioral change plan inclusive of patient-centered community resources. The CHW will provide ongoing support with goals and social needs for 6-months.

Group II: Wait-List Control Active Control 1 Intervention

Complete questionnaires at baseline (administered electronically or by mail). Follow-up measures will be administered immediately following their clinic visit and at 6-months after the clinic visit electronically and by mail. A PREVENT action plan (behavior change prescription, community resources, and education) will be provided to the patient via email after the completion of the follow-up measurement.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

Digital health interventions using Computerized Decision Support (CDS) and Machine Learning (ML) have shown promise in the prevention and treatment of childhood obesity, with all identified studies reporting statistically significant outcomes.

CDS tools, particularly those utilizing Electronic Health Records and BMI alerts, can aid in self-management of obesity, while ML algorithms like decision trees and artificial neural networks are effective for predicting obesity risk, highlighting the potential for smart interventions in childhood obesity care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized decision support and machine learning applications for the prevention and treatment of childhood obesity: A systematic review of the literature. Triantafyllidis, A., Polychronidou, E., Alexiadis, A., et al.[2021]

A systematic review of 55 randomized controlled trials involving 3406 records found that technology-based interventions for treating pediatric obesity resulted in a small but significant weight loss effect (effect size d = -0.13), although many studies did not show significant differences compared to control groups.

In contrast, prevention interventions using technology did not demonstrate a significant impact on weight outcomes, indicating that more research is needed to assess their effectiveness compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harnessing technological solutions for childhood obesity prevention and treatment: a systematic review and meta-analysis of current applications. Fowler, LA., Grammer, AC., Staiano, AE., et al.[2023]

Mobile health (mHealth) is significantly advancing cardiovascular care through innovative strategies like SMS for smoking cessation and apps for monitoring health, showing promise in prevention and rehabilitation.

Despite the potential of mHealth, many apps lack regulation and evidence-based support, highlighting the need for robust systems to ensure safety and effectiveness in delivering healthcare services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth in Cardiovascular Health Care. Chow, CK., Ariyarathna, N., Islam, SM., et al.[2022]

Citations

1.

jmir.org

jmir.org/2025/1/e64981/

Digital Health Solutions for Cardiovascular Disease ...

The majority of the study outcomes addressed blood pressure (14/30, 47%), exercise capacity (12/30, 40%), weight (12/30, 40%), and lipid profile ...

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bmcdigitalhealth.biomedcentral.com

bmcdigitalhealth.biomedcentral.com/articles/10.1186/s44247-024-00064-1

a randomized controlled pilot trial | BMC Digital Health

This pilot study examined the preliminary effectiveness of the PREVENT digital intervention that supports health care teams in delivering health behavior ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10587029/

Leveraging Digital Health to Improve the Cardiovascular ...

Numerous studies have demonstrated the effectiveness of digital health tools in reducing the burden of CVDs and improving outcomes by addressing ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4551455/

Digital Health Interventions for the Prevention of ...

Internet-based secondary prevention tool reduced CVD endpoints (15.7% vs. 4.6%) and provided a significant cost savings. The intervention group had a more ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT06063564?locStr=United+States&country=United+States&aggFilters=status%3A

Adapting and Testing a Novel Digital Health Tool ...

PREVENT visually displays patient-reported and electronic health record (EHR) data to facilitate counseling and deliver tailored physical activity and healthy ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11364112/

Transforming Cardiovascular Care With Digital Health

Digital health technologies (DHTs) offer a promising solution to bridge the existing gaps in health care delivery and provide strategies for improving health ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9362065/

The Potential Role of Digital Health in Obesity Care - PMC

This review will discuss the role that digital health could play in this new approach and the challenges of ensuring equitable access to digital health for ...

8.

nature.com

nature.com/articles/s44325-024-00020-y

a case-based review | npj Cardiovascular Health

This narrative review aims to equip clinicians with an understanding of how digital health innovations and artificial intelligence can be applied to clinical ...

9.

acc.org

acc.org/Latest-in-Cardiology/Articles/2025/07/01/01/Cover-Story-The-Future-of-Digital-Health-in-CVD

Cover Story | The Future of Digital Health in Cardiovascular ...

Use of these adaptive techniques will reduce timelines and generate robust data for the evaluation of risk and benefit of DHTs, as well as ...