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NCT Number: NCT06063564

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

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.

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Key information

Conditions

Obesity Body Weight Cardiovascular Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University in St. Louis

St Louis, Missouri, 63130, United States

Location status: Recruiting

Location contact

Maura M Kepper, PhD

CONTACT

[email protected]

3149350142

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Prevent

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 providers link patients to resources in their community.

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.

Primary outcomes

  1. Patients' satisfaction of PREVENT tool: survey

    Time frame: 6-months

    A survey (6-questions) will assess patient's satisfaction with the PREVENT tool. Questions are asked on a 5-point Likert scale (range: 6-30) with a higher score indicating greater satisfaction.

  2. Provider's satisfaction of PREVENT tool: survey

    Time frame: Up to 12 weeks post-study

    A survey (31-questions) will assess provider's acceptability and satisfaction with five aspects of health information technology: content, accuracy, format, ease of use and timeliness. Questions are asked on a 5-point Likert scale (range: 31-155) with a higher score indicating greater satisfaction.

  3. Fidelity of PREVENT tool implementation

    Time frame: 0-6 months

    Fidelity will be measured using direct observation of patient-provider interactions while using the PREVENT tool. A direct observation checklist will be used by the observer to determine the number of interactions with the PREVENT tool that were implemented as intended.

Secondary outcomes

  1. Change in provider confidence: survey

    Time frame: At baseline, and 6-months

    Provider confidence in discussing CVH and health behaviors with overweight and obese patients will be assessed using a survey (4-questions). Questions are asked on 5-point Likert scale (range: 4-20) with a higher score indicating greater confidence.

  2. Quality of health behavior counseling

    Time frame: Immediately following clinic visit

    Patient perceptions of the clinical interaction in which CVH and health behaviors will be assessed using a survey (10- questions). Questions are asked as yes/no/I don't' know. Quality counseling will be defined as patient reported yes to their care team: 1) talking to them about healthy food intake; 2) talking to them about physical activity 3) delivering goals and 4) delivering resources.

  3. Change in patient's motivation

    Time frame: At baseline, 3 months and 6-months

    A survey (15-question) administered to patients will assess motivation and self-efficacy for behavior change. Questions are asked using a 5-point Likert scale (range: 15-75) with a higher score indicating greater motivation.

  4. Change in food intake behaviors

    Time frame: At baseline, 3 months and 6-months

    Patient-reported food intake behaviors (fruit and vegetable intake, whole grains, sugar-sweetened beverages and snacking behaviors) are collected using a brief Health Behavior & Attitudes Survey.

  5. Change in minutes of moderate to vigorous physical activity

    Time frame: At baseline, 3 months and 6-months

    Patient-reported physical activity (minutes of moderate and vigorous activity per week) are collected using a survey (4-questions). Patients report the average number of minutes of moderate and vigorous activity they do per week.

  6. Change in body mass index (BMI)

    Time frame: At baseline, and 6-months

    Collected from patient's medical record.

  7. Change on patient's average systolic and diastolic blood pressure

    Time frame: At baseline, and 6-months

    Collected from patient's medical record.

  8. Change in patient's cholesterol

    Time frame: At baseline, and 6-months

    Collected from patient's medical record.

  9. Change in patient's blood glucose

    Time frame: At baseline, and 6-months

    Collected from patient's medical record.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Oct 2, 2023
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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