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NCT06063564 · ClinicalTrials.gov registry record · NA

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

A NA study of Obesity and Cardiovascular Diseases, sponsored by Washington University School of Medicine.

Recruiting
Registry status
NA
Development phase
60
Enrollment target
1
Study location

NCT06063564 is a NA study of Obesity and Cardiovascular Diseases that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 60 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06063564, a NA study of Obesity and Cardiovascular Diseases, is actively recruiting participants, sponsored by Washington University School of Medicine.

RECRUITING
Registry status
NA
Development phase
60 participants
Enrollment target
1
Study location

Study Summary

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
  • BEHAVIORAL Wait-list Control

Study Locations (1)

Missouri

  • Washington University in St. Louis - St Louis

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2024-08-20
Est. Completion 2028-01-31
Phase NA

What the Registry Record Tells You About NCT06063564

The ClinicalTrials.gov registry entry for NCT06063564 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (93% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which PREVENT is the first listed.

NCT06063564 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.

Frequently Asked Questions

What is clinical trial NCT06063564 about?

NCT06063564 is a clinical study titled "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. Counsel...

What is the current status of trial NCT06063564?

This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2024-08-20. Estimated completion is 2028-01-31.

What conditions does trial NCT06063564 study?

This clinical trial studies the following conditions: Obesity, Cardiovascular Diseases.

What interventions are being tested in trial NCT06063564?

The interventions under investigation include: PREVENT (BEHAVIORAL), Wait-list Control (BEHAVIORAL).

Who is sponsoring clinical trial NCT06063564?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06063564 being conducted?

This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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