N/A
N=65
PREVENT Tool Study: Late Effects Clinic
Cardiovascular Disease · Childhood Obesity
Bottom Line
View on ClinicalTrials.gov: NCT04530825 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Mean Change in Minutes of Moderate Physical Activity Per Week (From Self Report) Survey — 43.3; 16.8 minutes/week
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Wait-List Control (Other); PREVENT Tool (Other)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Minutes of Moderate Physical Activity Per Week (From Self Report) Survey |
43.3; 16.8 | — |
| PRIMARY Mean Change in Minutes of Vigorous Physical Activity Per Week (From Self Report) Survey |
-211.4; -1.4 | — |
| PRIMARY Mean Change in Number of Food Intake Behaviors Met |
0.15; 0.78 | — |
| PRIMARY Provider's Satisfaction of PREVENT Tool: Survey |
3.61 | — |
| PRIMARY Fidelity of PREVENT Tool Implementation |
— | — |
| SECONDARY Provider's Motivation for Sustained Use of PREVENT Tool |
2.79 | — |
| SECONDARY Maintenance of PREVENT Tool as Measured by Provider Perceptions of Feasibility of the Tool |
4; 4; 4 | — |
| SECONDARY Maintenance of PREVENT Tool as Measured by Provider Perceptions of Ease of Use of the Tool |
4; 4 | — |
| SECONDARY Patient's Perceptions of Usability/Acceptability of PREVENT Tool |
— | — |
| SECONDARY Parent's Perceptions of Usability/Acceptability of PREVENT Tool |
— | — |
| SECONDARY Impact of PREVENT Tool on Mean Change in Patient's Body Mass Index (BMI) |
0.09; -.03 | — |
| SECONDARY Impact of PREVENT Tool on Patient's Systolic and Diastolic Blood Pressure |
-1.38; 0.65; -0.49; -1.83 | — |
| SECONDARY Impact of PREVENT Tool on Patient's Cholesterol |
— | — |
| SECONDARY Impact of PREVENT Tool on Patient's Fasting Blood Glucose |
— | — |
| SECONDARY Impact of PREVENT Tool on Patient's Attitudes Toward Behavior Change |
0.16; 0.23 | — |
| SECONDARY Clinic-level Capacity for Sustainability as Measured by Provider Survey |
3.63 | — |
Summary
The purpose of this study is to test the feasibility of a novel, Health Information Technology behavior change tool in a single clinic setting. The PREVENT tool is the first electronic health record (EHR)-compatible tool that both tailors evidence-based behavior change strategies and incorporates community-level data specific to each patient into routine care. The central hypothesis is that PREVENT will improve patient's attitudes towards behavior change recommendations, increase adherence to recommended behavior change and improve cardiovascular health. Fifty adolescents will be randomized to intervention or wait-list, routine care control to assess the preliminary effectiveness of PREVENT. Qualitative and quantitative methods will be used among patients, parents and providers to examine barriers to current and future implementation of the PREVENT tool to inform adoption and maintenance.
Eligibility Criteria
Inclusion Criteria
Patient Eligibility Criteria:
- Adolescents 12 to 19 years
- Prior diagnosis of pediatric cancer (diagnosed <21 years of age)
- Not receiving active therapy for their cancer
- Receiving care from the Pediatric Hematology/Oncology staff and physicians at St. Louis Children's Hospital or the St. Louis Children's Specialty Care Center (CSCC)
- At risk for poor cardiovascular health (CVH) (BMI greater than or equal to 85th percentile)
Provider Eligibility Criteria -All providers and staff (physicians, nurses, clinic staff, clinical research associates) in the Pediatric Hematology/Oncology program at St. Louis Children's Hospital and the CSCC
Parent Eligibility Criteria
-A parent or legal guardian of a study participant. The parent or legal guardian must have been present at the clinic visit in which the PREVENT tool was administered to the study participant.
Data sourced from ClinicalTrials.gov (NCT04530825). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.