Dissemination and Implementation of Improving Pediatric Obesity Practice Using Prompts

Last updated: April 7, 2025
Sponsor: Yale University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Obesity

Diabetes Prevention

Treatment

Improving Pediatric Obesity Practice Using Prompts (iPOP-UP)

Clinical Study ID

NCT05627011
2000033551
5R01MD014853
  • Ages > 2
  • All Genders

Study Summary

The purpose of this study is to evaluate the dissemination and implementation of electronic health record-based clinical decision support tools for the management of pediatric overweight and obesity in primary care.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Primary Care Practices: all primary care practices using the EHR system of one ofthe 3 health systems participating in the study that agree to participate in theiPOP-UP trial;

  • Clinician-participants: all clinicians who delivery pediatric primary care at theparticipating practices, including physicians and physicians-in-training (residentsand fellows), physician assistants (PA), nurse practitioners (NP)/advanced practiceregistered nurses (APRNs);

  • Patient-participants: all patients ages 2-18 with overweight/obesity seen during thestudy period may be impacted by the intervention. A limited dataset will becollected for the subset of these 2 to 18 years old patients with BMI ≥ 85thpercentile for age and sex seen for a well or follow-up visit during the studyperiod in a primary care department and conducted by a prescribing clinician (physician, NP, PA)

Exclusion

Exclusion Criteria:

  • None - exclusion criteria are purposefully limited in this real-world implementationstudy

Study Design

Total Participants: 240772
Treatment Group(s): 1
Primary Treatment: Improving Pediatric Obesity Practice Using Prompts (iPOP-UP)
Phase:
Study Start date:
February 09, 2023
Estimated Completion Date:
June 30, 2025

Study Description

This study will evaluate iPOP-UP, a newly-optimized intervention to improve adherence to national guidelines for the management of childhood obesity, among 84 primary care practices affiliated with three health systems serving children with racial and ethnic, socio-economic, rural-urban, and geographic diversity.

This multi-site, parallel 2-arm cluster randomized controlled "Hybrid Type 2" effectiveness-implementation trial will use mixed methods (electronic health record (EHR) data analysis, surveys, interviews, and focus groups) to simultaneously evaluate (1) the effectiveness of the iPOP-UP implementation package in improving clinical care and children's BMI outcomes in pediatric primary care setting and (2) the impact of the implementation strategy on the reach, adoption, fidelity, cost, and maintenance of the intervention.

The unit of randomization in this study is pediatric primary care practices. Within the participating 84 practices, pediatric primary care clinicians working at the implementation sites will be invited to participate in pre- and post-intervention surveys assessing their practice behaviors, obesity-related attitudes, beliefs, and self-efficacy, EHR usage and attitudes, and training preferences. In addition, a limited data set of EHR from patients visits will be queried and analyzed to evaluate clinical care outcomes and children's BMI outcomes. Limited data (to include dates and geographic information but no facial identifiers) will be queried and analyzed for all children 1) age 2.0 to ≤18 years-old at baseline, 2) with a well-child visit, during which height and weight are measured, at one of the participating practices during the study period, and 3) with a BMI ≥85th percentile for age/sex (CDC criteria for overweight/obesity).

Outcomes include: (a) change in BMI, measured as the yearly change in BMI expressed as a percentage of the 95th percentile (%BMIp95); (b) Change in clinicians' objective practice around managing elevated BMI in primary care using EHR data; (c) Change in clinicians' self-reported knowledge, attitudes, and practice around managing elevated BMI in primary care; and (d) Utilization of Clinical Decision Support (CDS) tools. The investigators will also describe implementation outcomes (reach, adoption, fidelity/adaptation, and cost) through qualitative and quantitative data collection from members of the study team throughout the process of implementation.

Connect with a study center

  • Eskenazi Health

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Duke University

    Durham, North Carolina 27708
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.