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

NCT ID: NCT06397729

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2026-07-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Wait-List Control

Intervention Type: BEHAVIORAL

Will receive routine clinical care. After completion of follow-up measures, control participants will receive a behavior change prescription via the PREVENT tool

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.

Group Type: EXPERIMENTAL

PREVENT Tool

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Aged 18-64 years at baseline
• Low income (household income <200% FPL)
• 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)

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Missouri Highlands Health Care

UNKNOWN

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Maura Mohler Kepper

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maura Kepper, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University in St. Louis

St Louis, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Maura Kepper, PhD

Role: CONTACT

kepperm@wustl.edu

314-935-0142

Facility Contacts

Maura Kepper

Role: primary

kepperm@wustl.edu

314-935-0142

Other Identifiers

202309157

Identifier Type: -

Identifier Source: org_study_id