Patients are searching for this trial right now

This page is already ranking on Google. Activate it to start receiving pre-qualified patient leads directly in your inbox.

14-day free trial · $44/mo after · Cancel anytime · Money-back guarantee

NCT06397729 · Washington University School of Medicine

Evaluation of a Novel Technology to Support Tailored Health Behavior Counseling in Rural Primary Care Clinics

(Rural PREVENT)

What this study is about

This project will conduct a pilot hybrid study that examines the implementation (Aims 1 \& 2) and preliminary effectiveness (Aim 3) of PREVENT, a digital health intervention, among patients with overweight/obesity (N=100) using a clinic-randomly assigned design.

View original scientific description

This project will conduct a pilot hybrid study that examines the implementation (Aims 1 \& 2) and preliminary effectiveness (Aim 3) of PREVENT, a digital health intervention, among patients with overweight/obesity (N=100) using a clinic-randomized design. The central hypothesis of the study is that PREVENT will be feasible and show improvements in health behavior counseling and the patient experience that will improve patients' motivation to change, and their CVH health behaviors and outcomes.

Interventions

BEHAVIORAL

Wait-List Control

Will receive routine clinical care. After completion of follow-up measures, control participants will receive a behavior change prescription via the PREVENT tool

BEHAVIORAL

PREVENT Tool

PREVENT is a novel Health Information Technology tool designed to promote physical activity and healthy food intake among overweight/obese patients at the point of care. PREVENT automates the delivery of personalized, evidence-based behavior change recommendations and provides an interactive map of community resources to help the care team link patients to resources in their community. PREVENT follows up with patients electronically and communicates progress on behavior change to the care team.

Primary outcome measures

Healthcare team member confidence

Time frame: baseline, at study completion (3 years)

A survey (4-questions) will assess provider's confidence in delivering health behavior counseling and discussing cardiovascular health with patients. Questions are asked on a 5-point Likert scale (range: 4-20) with a higher score indicating greater satisfaction. Change in confidence from baseline to post-study will be compared in intervention clinics versus control clinics.

Quality counseling

Time frame: Within 48 hours of clinic visit

A 12 question survey will ask patients 1) if they have been counseled on 10 topics Life's Essential 8 (obesity, blood pressure, physical activity, food intake, smoking, sleep, cholesterol, and diabetes), and two distractor topics (flu vaccination and seat belt use); 2) if they received goals for healthy eating and/or physical activity; and 3) if they received resources to support their health. Discussion of physical activity and/or food intake will satisfy that health behavior counseling was delivered. Yes' to physical activity or food intake counseling and 'yes' to receipt of tailored goals and/or resources will satisfy the 'quality behavioral counseling' outcome.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • Aged 18-64 years at baseline
  • Low income (household income \<200% FPL)
  • At risk for poor CVH (body mass index greater than or equal to 30)
  • Receiving care from the Missouri Highlands Healthcare
  • Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable) Provider Inclusion Criteria: • All providers and clinic staff (physicians, nurses, community health workers, clinic staff, clinic research associates) in the Missouri Highlands Healthcare Clinics are eligible to participate.

Where

  • St Louis, Missouri

Collaborators

Missouri Highlands Health Care

Related conditions & keywords

Cardiovascular DiseasesObesityDigital healthBehavior ChangePhysical ActivityDietCardiovascular DiseaseRural health

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Jul 17, 2026 · Source of record for eligibility and locations

📊
1 of 100 participants interested
1% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

St Louis

Missouri

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

Find More Heart Disease Trials by City

Browse all heart disease clinical trials in these cities — not just this study.

Looking for Cardiovascular Diseases Treatment in St Louis?

Join others in Missouri exploring innovative treatment options through clinical research

Cardiovascular Diseases Treatment Options in St Louis, Missouri

If you're searching for Cardiovascular Diseases treatment in St Louis, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in St Louis and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Cardiovascular Diseases. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Missouri
Now Enrolling
Up to 100 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Cardiovascular Diseases?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Cardiovascular Diseases

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Cardiovascular Diseases Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06397729. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.