NCT06397729

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Cardiovascular disease (CVD) prevalence is 40% higher among rural than urban residents in the United States. Maintaining healthy weight, physical activity, and food intake behaviors promotes cardiovascular health (CVH) and prevents CVD. The Health Resources and Services Administration requires health behavior counseling and follow-up care for patients with elevated body mass index. Counseling is most effective when developed with and tailored to the patient and offered with resources that support healthy food intake and physical activity. Healthcare teams are challenged by the lack of accessible evidence-based, tailored recommendations and limited awareness of patient health behaviors and community resources, all of which are compounded by lack of time within the clinical workflow. Yet, digital health tools that can facilitate quality counseling and follow-up are not readily available for primary care teams - particularly those in low-resourced rural settings. The investigators will leverage our existing digital health tool (PREVENT) for healthcare teams, including Community Health Workers (CHWs), to use at the point-of-care with rural low-income patients who are overweight or obese and often have more severe social needs. PREVENT visually displays patient-reported and electronic health record data to facilitate counseling and deliver tailored physical activity and healthy food intake goals and resources. The investigators have been working with the Missouri Highlands Health Care, a federally-qualified health center with 10 clinics across 7 rural counties that has an existing CHW network, to adapt our tool to meet the needs of their health care teams and patients. This project will examine the implementation (Aims 1 \& 2) and preliminary effectiveness (Aim 3) of PREVENT among patients with overweight/obesity (N=100) using a clinic-randomized design in four clinics. The investigators believe that PREVENT will be feasible and show improvements in health behavior counseling and the patient experience that will improve patients' motivation to change, CVH health behaviors, and outcomes. The investigators will seek to understand factors impacting implementation and sustainment of this approach to streamline the translation of this tool into routine care. Our ultimate goal is to improve CVH with enhanced health behavior counseling and follow-up using a multi-level approach that targets health behaviors and unmet social needs to give everyone an equal opportunity for health.

Conditions

• Cardiovascular Diseases
• Obesity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-04-30
• Completion: 2026-07-30
• First posted: 2024-05-03
• Last updated: 2025-06-13

Locations

1 site across 1 country: United States