---
title: Adapting and Testing a Novel Digital Health Tool (PREVENT) to Improve Health Behavior Counseling and Cardiovascular Health in Rural Primary Care Clinics
nct_id: NCT06063564
overall_status: RECRUITING
phase: NA
sponsor: Washington University School of Medicine
study_type: INTERVENTIONAL
primary_condition: Obesity
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06063564.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06063564"
ct_last_update_post_date: 2025-10-16
last_seen_at: "2026-05-12T07:23:18.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Adapting and Testing a Novel Digital Health Tool (PREVENT) to Improve Health Behavior Counseling and Cardiovascular Health in Rural Primary Care Clinics

**NCT ID:** [NCT06063564](https://clinicaltrials.gov/study/NCT06063564)

## Key Facts

- **Status:** RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 60
- **Lead Sponsor:** Washington University School of Medicine
- **Conditions:** Obesity, Cardiovascular Diseases
- **Start Date:** 2024-08-20
- **Completion Date:** 2028-01-31
- **CT.gov Last Update:** 2025-10-16

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 64 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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).
```

## Arms

- **Wait-List Control** (ACTIVE_COMPARATOR) — 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.
- **PREVENT Intervention** (EXPERIMENTAL) — 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** (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 providers link patients to resources in their community.
- **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.

## Primary Outcomes

- **Patients' satisfaction of PREVENT tool: survey** _(time frame: 6-months)_ — A survey (6-questions) will assess patient's satisfaction with the PREVENT tool. Questions are asked on a 5-point Likert scale (range: 6-30) with a higher score indicating greater satisfaction.
- **Provider's satisfaction of PREVENT tool: survey** _(time frame: Up to 12 weeks post-study)_ — A survey (31-questions) will assess provider's acceptability and satisfaction with five aspects of health information technology: content, accuracy, format, ease of use and timeliness. Questions are asked on a 5-point Likert scale (range: 31-155) with a higher score indicating greater satisfaction.
- **Fidelity of PREVENT tool implementation** _(time frame: 0-6 months)_ — Fidelity will be measured using direct observation of patient-provider interactions while using the PREVENT tool. A direct observation checklist will be used by the observer to determine the number of interactions with the PREVENT tool that were implemented as intended.

## Secondary Outcomes

- **Change in provider confidence: survey** _(time frame: At baseline, and 6-months)_
- **Quality of health behavior counseling** _(time frame: Immediately following clinic visit)_
- **Change in patient's motivation** _(time frame: At baseline, 3 months and 6-months)_
- **Change in food intake behaviors** _(time frame: At baseline, 3 months and 6-months)_
- **Change in minutes of moderate to vigorous physical activity** _(time frame: At baseline, 3 months and 6-months)_
- **Change in body mass index (BMI)** _(time frame: At baseline, and 6-months)_
- **Change on patient's average systolic and diastolic blood pressure** _(time frame: At baseline, and 6-months)_
- **Change in patient's cholesterol** _(time frame: At baseline, and 6-months)_
- **Change in patient's blood glucose** _(time frame: At baseline, and 6-months)_

## Locations (1)

- Washington University in St. Louis, St Louis, Missouri, United States — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.washington university in st. louis|st louis|missouri|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06063564.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06063564*  
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