PREVENT: a digital tool to tailor diet and activity counseling in rural primary care
Evaluation of a Novel Technology to Support Tailored Health Behavior Counseling in Rural Primary Care Clinics
NA · Washington University School of Medicine · NCT06397729
This pilot will test whether the PREVENT digital tool helps low-income rural adults with obesity get more personalized diet and physical activity advice during primary care visits.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Washington University School of Medicine (other) |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT06397729 on ClinicalTrials.gov |
What this trial studies
This clinic-randomized hybrid pilot will enroll about 100 low-income adults with obesity receiving care in Missouri Highlands Healthcare clinics to test the PREVENT digital health tool. PREVENT aggregates patient-reported measures and electronic health record data to visually support clinicians and community health workers in delivering tailored physical activity and healthy-eating goals and local resources. The study uses a wait-list control design and measures both implementation outcomes (feasibility, workflow fit, counseling quality) and preliminary effectiveness on motivation, behavior change, and cardiovascular health indicators. Investigators will combine quantitative measures and implementation process data to understand how the tool performs in low-resourced rural primary care settings.
Who should consider this trial
Good fit: Adults aged 18–64 with household income below 200% of the federal poverty level, BMI ≥30, who receive care from Missouri Highlands Healthcare and can consent are the intended participants.
Not a fit: Patients who do not meet the age, income, or BMI criteria, do not receive care at participating clinics, or lack access to participate in the clinic-based digital workflow are unlikely to benefit from this project.
Why it matters
Potential benefit: If successful, PREVENT could make counseling more personalized and actionable, increasing patients' motivation and improving diet, activity, weight, and other cardiovascular health measures.
How similar studies have performed: Prior digital and tailored behavior-change interventions have shown modest improvements in diet and physical activity, but few have tested tailored point-of-care tools in low-resource rural primary care settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Patient Inclusion Criteria: * 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) 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.
Where this trial is running
St Louis, Missouri
- Washington University in St. Louis — St Louis, Missouri, United States (RECRUITING)
Study contacts
- Principal investigator: Maura Kepper, PhD — Washington University School of Medicine
- Study coordinator: Maura Kepper, PhD
- Email: kepperm@wustl.edu
- Phone: 314-935-0142
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiovascular Diseases, Obesity, Digital health, Behavior Change, Physical Activity, Diet, Cardiovascular Disease, Rural health