Recruiting

PREVENT

Sponsor:

Washington University School of Medicine

Code:

NCT06397729

Conditions

Cardiovascular Diseases

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Wait-List Control

PREVENT Tool

Study Details

Brief summary:

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.

Conditions

Cardiovascular Diseases

Obesity

Study ID

NCT06397729

Start date

Nov 1, 2024

Status verified date

Jul, 2026

Completion date

Jul 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Patient Inclusion Criteria:

  • Aged 18-64 years at baseline
  • 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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Patients - Wait-List Control

  • Complete questionnaires at baseline, within 48 hours of their routine clinic visit, and 6-months after the clinic visit. All surveys will be administered electronically or 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.

experimental: Patients- PREVENT Tool

  • Complete questionnaires at baseline, within 48 hours of their routine clinic visit, and 6-months after the clinic visit. All surveys will be administered electronically or by mail
  • At the clinic visit, the provider will use the PREVENT tool to discuss CVH risk and deliver a tailored behavioral change plan inclusive of patient-centered community resources. Community Health Workers will follow up with patients monthly to support behavior change.

no intervention: Providers

All eligible providers will be sent questionnaires electronically to their email at baseline, following provider training and follow-up. Providers will be invited to attend a training session to educate them on the PREVENT tool at baseline.

Interventions

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

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 measure

  • Healthcare team member confidence [ Time Frame: baseline, at study completion (3 years) ]
  • Quality counseling [ Time Frame: Within 48 hours of clinic visit ]

Central Contacts and Locations

Central contacts

Maura Kepper, PhD

314-935-0142kepperm@wustl.edu

Locations

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 63130

Contacts

Maura Kepper

314-935-0142kepperm@wustl.edu

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Keywords

  • Digital health
  • Behavior Change
  • Physical Activity
  • Diet
  • Cardiovascular Disease
  • Obesity
  • Rural health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-07-17.