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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06397729
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Wait-List Control — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Nov 1, 2024
Status verified
May 2025
Primary completion
Apr 30, 2026
Completion
Jul 30, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

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.

Primary Outcome Measure

Healthcare team member confidence [ Time Frame: baseline, at study completion (3 years) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University in St. LouisSt LouisMissouri63130
Maura Kepper
[email protected]
314-935-0142

Find similar trials in St Louis, MO

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Washington University in St. Louis· St Louis, MO

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