Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06397729

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 64 Years

SexAll

Healthy volunteersNot accepted

ConditionCardiovascular Diseases, Obesity

Full registry criteria

Patient Inclusion Criteria: * Aged 18-64 years at baseline * 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) Provider Inclusion Criteria: • 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.

Treatments and study arms

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

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.

Primary outcomes

Healthcare team member confidencebaseline, at study completion (3 years)

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.

Quality counselingWithin 48 hours of clinic visit

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Washington University in St. Louis🇺🇸 St Louis, Missouri, United States

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Maura KepperContact

Email · Call 314-935-0142