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

NCT06397729 | Recruiting DMC

• 1 other identifier: 202309157
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Obesity

Keywords

Digital health; Behavior Change; Physical Activity; Diet; Cardiovascular Disease; Obesity; Rural health

Outcome Measures

Primary Outcomes (2)

• Healthcare team member confidence

  A survey (4-questions) will assess provider's confidence in delivering health behavior counseling and discussing cardiovascular health with patients. Questions are asked on a 5-point Likert scale (range: 4-20) with a higher score indicating greater satisfaction. Change in confidence from baseline to post-study will be compared in intervention clinics versus control clinics.

  baseline, at study completion (3 years)

• Quality counseling

  A 12 question survey will ask patients 1) if they have been counseled on 10 topics Life's Essential 8 (obesity, blood pressure, physical activity, food intake, smoking, sleep, cholesterol, and diabetes), and two distractor topics (flu vaccination and seat belt use); 2) if they received goals for healthy eating and/or physical activity; and 3) if they received resources to support their health. Discussion of physical activity and/or food intake will satisfy that health behavior counseling was delivered. Yes' to physical activity or food intake counseling and 'yes' to receipt of tailored goals and/or resources will satisfy the 'quality behavioral counseling' outcome.

  Within 48 hours of clinic visit

Secondary Outcomes (12)

• Provider satisfaction

  at study completion (3 years)

• Shared Decision Making

  3 months into study

• Resource Offering

  6-months

• Patient satisfaction

  Within 48 hours of clinic visit

• Patient motivation to change

  at baseline, and 6-months

Study Arms (3)

Patients - Wait-List Control

ACTIVE COMPARATOR

* 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.

Behavioral: Wait-List Control

Patients- PREVENT Tool

EXPERIMENTAL

* 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.

Behavioral: PREVENT Tool

Providers

NO INTERVENTION

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.

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

Patients - Wait-List Control

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.

Patients- PREVENT Tool

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Missouri Highlands Health Care: collaborator

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63130, United States

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Maura Kepper, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maura Kepper, PhD

CONTACT

314-935-0142; kepperm@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: May 3, 2024
• Study Start: November 1, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)