Recruiting

PREVENT

Sponsor:

Washington University School of Medicine

Code:

NCT06063564

Conditions

Obesity

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

PREVENT

Wait-list Control

Study Details

Brief summary:

The focus on this application is low-income, rural patients, since cardiovascular disease (CVD) prevalence is 40% higher among rural than urban residents. Health behavior counseling and follow-up care are required for patients with an elevated body mass index who have increased risk for CVD. Counseling is most effective when developed with, and tailored to, the patient and offered with resources that support healthy food intake and physical activity. Resource referral and follow-up is particularly important in rural low income residents who often have more severe social needs that impede healthy behaviors. The proposed research will leverage the candidate's digital health tool (PREVENT) for healthcare teams to use within the clinic visit. PREVENT visually displays patient-reported and electronic health record (EHR) data to facilitate counseling and deliver tailored physical activity and healthy food intake goals and resources. PREVENT may improve the quality of required care and promote cardiovascular health equity. This research will: 1) collaborate with rural and clinic partners to modify and integrate the PREVENT tool for low-income, rural patients with obesity (Aim 1); and 2) conduct a pilot pragmatic clinical trial of PREVENT to optimize feasibility, acceptability, appropriateness, and potential health equity impact.

Conditions

Obesity

Cardiovascular Diseases

Study ID

NCT06063564

Start date

Aug 20, 2024

Status verified date

Jul, 2026

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Aged 18-64 years at baseline
  • a BMI ≥ 30
  • 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).

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Wait-List Control

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.

experimental: PREVENT 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.

Interventions

PREVENT

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 providers link patients to resources in their community.

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.

Primary outcome measure

  • Patients' satisfaction of PREVENT tool: survey [ Time Frame: 6-months ]
  • Provider's satisfaction of PREVENT tool: survey [ Time Frame: Up to 12 weeks post-study ]
  • Fidelity of PREVENT tool implementation [ Time Frame: 0-6 months ]

Central Contacts and Locations

Locations

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 63130

Contacts

Maura M Kepper, PhD

3149350142kepperm@wustl.edu

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

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 2026-07-16.