Skip to main content
OpenTrials
Completed

NCT Number: NCT05627011

Dissemination and Implementation of Improving Pediatric Obesity Practice Using Prompts

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eskenazi Health, Indianapolis, Indiana, United States

Loading trial locations.

About this study

This study will evaluate iPOP-UP, a newly-optimized intervention to improve adherence to national guidelines for the management of childhood obesity, among 81 primary care practices, grouped into 71 clinic clusters, 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 Body Mass Index (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 practice clusters. Within the participating 71 clusters, 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary Care Practices: all primary care practices using the EHR system of one of the 3 health systems participating in the study that agree to participate in the iPOP-UP trial;
  • Clinician-participants: all clinicians who delivery pediatric primary care at the participating practices, including physicians and physicians-in-training (residents and fellows), physician assistants (PA), nurse practitioners (NP)/advanced practice registered nurses (APRNs);
  • Patient-participants: all patients ages 2-18 with overweight/obesity seen during the study period may be impacted by the intervention. A limited dataset will be collected for the subset of these 2 to 18 years old patients with BMI ≥ 85th percentile for age and sex seen for a well or follow-up visit during the study period in a primary care department and conducted by a prescribing clinician (physician, NP, PA)

Exclusion criteria

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

Treatment and study plan

Improving Pediatric Obesity Practice Using Prompts (iPOP-UP)

Behavioral

EHR-based CDS tools refined through a formative evaluation and user-centered design process that immediately preceded this study.

Primary outcomes

  1. Mean Change in BMI as Percentage of 95th Percentile

    Time frame: Up to 15 months after first primary care visit following trial launch

    Calculated as a percentage of the participant's BMI (m/kg2) divided by the BMI (m/kg2) at the 95th percentile for the participant's age and sex based on CDC growth curves.

    A negative percentage indicates that the participant's BMI has decreased since trial launch.

  2. Percent Adherence in Composite Measure of Clinician's Adherence to Clinical Guidelines, for Visits Completed Among Children 2-18 Years-old With BMI ≥85th Percentile.

    Time frame: 6 months after trial launch

    Percent change in composite measure of adherence to clinical guidelines, calculated from practice behaviors queried from the EHR. A dichotomous variable, adherence is defined as whether or not, for each relevant visit, the clinician followed all evidence of recommended obesity-related care during the study period:

    • Inclusion of diagnosis code indicating high BMI in visit diagnosis associated with the visit or as an active diagnosis in the problem list
    • Recommended lab orders for obesity related comorbidities, if eligible
    • Appropriate blood pressure (BP) measurement in children 3 years and older
    • Counseling diagnosis codes or structured documentation (every visit)
    • Follow-up visit requested at visit or active referral order for further management of obesity

    A score of 1 indicates that a clinician followed all evidence of recommended obesity-related care; a score of 0 indicates that a clinician did not follow at least one recommendation for obesity-related care.

Secondary outcomes

  1. Percent Adherent Visits in Composite Measure of Clinician's Adherence to Clinical Guidelines

    Time frame: 12 and 18 months after trial launch

    Percent adherent visits at 12 and 18 months in composite measure of adherence to clinical guidelines, calculated from practice behaviors queried from the EHR. A dichotomous variable, adherence is defined as whether or not, for each relevant visit, the clinician followed all evidence of recommended obesity-related care during the study period:

    • Inclusion of diagnosis code indicating high BMI in visit diagnosis associated with the visit or as an active diagnosis in the problem list
    • Recommended lab orders for obesity related comorbidities, if eligible
    • Appropriate BP measurement in children 3 years and older
    • Counseling diagnosis codes or structured documentation (every visit)
    • Follow-up visit requested at visit or active referral order for further management of obesity

    A score of 1 indicates that a clinician followed all evidence of recommended obesity-.related care; a score of 0 indicates that a clinician did not follow at least one recommendation.

  2. Percent Visits With Inclusion of Diagnosis Code Indicating High BMI in Problem List

    Time frame: 6, 12 and 18 months after trial launch

    Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of inclusion of diagnosis code indicating high BMI in problem list, queried from the electronic health record at baseline, 6, 12, and 18 months to see change at 6 months and how it's sustained at 12 and 18 months.

    A higher proportion of visits with relevant diagnosis code is consistent with recommended care.

  3. Percent Visits With Inclusion of Diagnosis Code Indicating High BMI in Visit Diagnosis

    Time frame: 6, 12 and 18 months after trial launch

    Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of inclusion of diagnosis code indicating high BMI queried from the electronic health record.

    A higher proportion of visits with relevant diagnosis code is consistent with recommended care.

  4. Percent Adherent Visits to Guideline Recommended Screening Lab Orders for Obesity Related Comorbidities, if Eligible

    Time frame: 6, 12 and 18 months after trial launch

    Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of screening lab orders for obesity-related comorbidities recommended by the American Academy of Pediatrics clinical practice guideline for obesity based on age and BMI percentile, queried from the electronic health record.

    A higher proportion of visits with recommended screening lab orders is consistent with recommended care.

  5. Percent Adherent Visits in Appropriate Blood Pressure Screening

    Time frame: 6, 12 and 18 months after trial launch

    Percent adherent visits completed among children 3-18 years with BMI ≥85th percentile during the study period with evidence of appropriate blood pressure screening queried from the electronic health record.

    A higher proportion of visits with blood pressure screening is consistent with recommended care.

  6. Percent Adherent Visits in Structured Documentation of Counseling

    Time frame: 6, 12 and 18 months after trial launch

    Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of counseling structured documentation queried from the electronic health record.

    A higher proportion of visits with counseling structured documentation is consistent with recommended care.

  7. Percent Visits With Follow-up Visit Requested

    Time frame: 6, 12 and 18 months after trial launch

    Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of follow-up visit requested, queried from the electronic health record.

    A higher proportion of visits with follow-up visit requested is consistent with recommended care.

  8. Percent Visits With Referral for Further Management of Obesity

    Time frame: 6, 12 and 18 months after trial launch

    Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of referral for further management of obesity queried from the electronic health record.

    A higher proportion of visits with follow-up or referral for further management of obesity is consistent with recommended care.

  9. Percent Visits With Weight Loss Medication Orders, if Eligible

    Time frame: 6, 12 and 18 months after trial post intervention launch

    Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of weight loss medication orders, if eligible, queried from the electronic health record.

    A higher proportion of visits with weight loss medication orders, when eligible, is consistent with recommended care.

  10. Percent Visits With Bariatric Surgery Program Referrals, if Eligible

    Time frame: 6, 12 and 18 months after trial launch

    Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of bariatric surgery program referrals, if eligible queried from the electronic health record.

    A higher proportion of referrals to bariatric surgery programs, when eligible, is consistent with recommended care.

  11. Percent Change in Potentially Unnecessary Insulin or Thyroid Laboratory Tests Ordered

    Time frame: 6, 12 and 18 months after trial launch

    Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of insulin or thyroid lab orders, not routinely recommended for evaluation of children with obesity, queried from the electronic health record.

    A lower proportion indicates better adherence to recommended care.

  12. Percent Visits With Clinicians' Utilization of the Clinical Decision Support Tools

    Time frame: 6, 12 and 18 months following trial launch

    Visits completed among children 2-18 years with BMI ≥85th percentile during the study period with evidence of clinician use of the clinical decision support tools in the electronic health record developed for this trial, calculated from electronic health record query.

    Measure= % of visits at intervention sites at which the clinicians' uses clinical decision support tools through18 months

    A higher proportion indicates greater utilization of clinical decision support tools.

  13. Mean Change in Clinicians' Attitudes and Practice Around Managing Elevated BMI in Primary Care

    Time frame: baseline and 6 months post intervention launch

    Mean change in clinician's attitudes and practice around management of elevated BMI measured using survey questions. Five factors will be assessed: Practice, Treatment self-efficacy, Counseling self-efficacy, Expectations, and Technology. Possible responses range from 1 (strongly disagree) to 5 (strongly agree) for attitudes or 1 (never) to 5 (almost always). Negative values indicate higher disagreement.

  14. Total Cost and Cost-effectiveness of iPOP-UP

    Time frame: From 6 months before trial launch and up to 15 months after first primary care visit following trial launch

    Total cost of design, build, implementation of the tools, and other implementation strategies of iPOP-UP incurred by the clinics. Using a healthcare sector perspective, a micro-costing approach was utilized to estimate costs associated with the design, build, and implementation of EHR-based CDS for the management of pediatric overweight/obesity in primary care.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Dissemination and Implementation of Decision Support for the Management of Overweight and Obesity in Pediatric Primary Care - Improving Pediatric Obesity Practice Using Prompts

Acronym: iPOP-UP

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 25, 2022
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.