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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: f
View:

• 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.

Locations
United States
Missouri
Washington University in St. Louis
RECRUITING
St Louis
Contact Information
Primary
Maura Kepper, PhD
kepperm@wustl.edu
314-935-0142
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2026-07-30
Participants
Target number of participants: 100
Treatments
Active_comparator: Patients - Wait-List Control
* 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.
Experimental: Patients- PREVENT Tool
* 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.
No_intervention: Providers
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.
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine
Collaborators: Missouri Highlands Health Care

This content was sourced from clinicaltrials.gov