Adapting and Testing a Novel Digital Health Tool (PREVENT) to Improve Health Behavior Counseling and Cardiovascular Health in Rural Primary Care Clinics

Overview

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.

Interventions

• Behavioral PREVENT
  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.
• 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.

Primary outcome measures

• Patients' satisfaction of PREVENT tool: survey [Time frame: 6-months]
• Provider's satisfaction of PREVENT tool: survey [Time frame: Up to 12 weeks post-study]
• Fidelity of PREVENT tool implementation [Time frame: 0-6 months]

Secondary outcome measures (9)

• 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]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• Washington University in St. Louis — St Louis

Identifiers

NCT: NCT06063564 · 202307156

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗