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Obesity, ChildhoodiPOP-UPNCT05627011

Dissemination and Implementation of Improving Pediatric Obesity Practice Using Prompts

A study testing Improving Pediatric Obesity Practice Using Prompts (iPOP-UP) in people with Obesity, Childhood, run by Yale University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 years and older
Conditions the study is for
Obesity, Childhood
What is being tested?
Improving Pediatric Obesity Practice Using Prompts (iPOP-UP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58,364 participants
Where
3 sitesUnited States
Study dates
9 Feb 2023to 14 Dec 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • Duke University

    Durham, North Carolina, 27708

  • Eskenazi Health

    Indianapolis, Indiana, 46202

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Dissemination and Implementation of Decision Support for the Management of Overweight and Obesity in Pediatric Primary Care - 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.

Read the detailed description

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.

Being tested
Improving Pediatric Obesity Practice Using Prompts (iPOP-UP)
Keywords
Clinical Decision Support, Implementation Science, Pediatric Obesity
Medical subject headings
Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Improving Pediatric Obesity Practice Using Prompts (iPOP-UP)Behavioural

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

Study groups in NCT05627011
Study groupRoleWhat they receive
Clinical Decision Support ToolExperimentalPractices assigned to iPOP-UP intervention which involves EHR-based CDS tools refined through a formative evaluation and user-centered design.
Receives: Behavioral: Improving Pediatric Obesity Practice Using Prompts (iPOP-UP)
ControlNo interventionPractices assigned to usual care that will not have access to the iPOP-UP CDS tool but will have access to many opportunities available to all pediatric clinicians nationally around the release of the new American Academy of Pediatrics guidelines for obesity management.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Up to 15 months after first primary care visit following 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.

    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:

    1. Inclusion of diagnosis code indicating high BMI in visit diagnosis associated with the visit or as an active diagnosis in the problem list
    2. Recommended lab orders for obesity related comorbidities, if eligible
    3. Appropriate blood pressure (BP) measurement in children 3 years and older
    4. Counseling diagnosis codes or structured documentation (every visit)
    5. 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.

    Measured: 6 months after trial launch

Secondary outcomes (14)
  1. Percent Adherent Visits in Composite Measure of Clinician's Adherence to Clinical Guidelines

    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:

    1. Inclusion of diagnosis code indicating high BMI in visit diagnosis associated with the visit or as an active diagnosis in the problem list
    2. Recommended lab orders for obesity related comorbidities, if eligible
    3. Appropriate BP measurement in children 3 years and older
    4. Counseling diagnosis codes or structured documentation (every visit)
    5. 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.

    Measured: 12 and 18 months after trial launch

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

    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.

    Measured: 6, 12 and 18 months after trial launch

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

    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.

    Measured: 6, 12 and 18 months after trial launch

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

    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.

    Measured: 6, 12 and 18 months after trial launch

  5. Percent Adherent Visits in Appropriate Blood Pressure Screening

    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.

    Measured: 6, 12 and 18 months after trial launch

  6. Percent Adherent Visits in Structured Documentation of Counseling

    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.

    Measured: 6, 12 and 18 months after trial launch

  7. Percent Visits With Follow-up Visit Requested

    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.

    Measured: 6, 12 and 18 months after trial launch

  8. Percent Visits With Referral for Further Management of Obesity

    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.

    Measured: 6, 12 and 18 months after trial launch

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

    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.

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

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

    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.

    Measured: 6, 12 and 18 months after trial launch

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

    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.

    Measured: 6, 12 and 18 months after trial launch

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

    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.

    Measured: 6, 12 and 18 months following trial launch

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

    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.

    Measured: baseline and 6 months post intervention launch

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

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2022
  2. Study start9 Feb 2023
  3. Primary completion14 Dec 2024
  4. Study completion14 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a multi-site, parallel 2-arm cluster randomized controlled trial "Hybrid Type 2" effectiveness-implementation study to simultaneously evaluate (1) the effectiveness of iPOP-UP in improving clinical care and child weight 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.
Masking
None (open label)
Enrolment
58,364 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05627011
Sponsor's protocol ID
2000033551
Other IDs
5R01MD014853
Acronym
iPOP-UP
Status last verified
Mar 2026
First submitted
15 Nov 2022
Last updated
19 Mar 2026
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ray J, Finn EB, Tyrrell H, Aloe CF, Perrin EM, Wood CT, Miner DS, Grout R, Michel JJ, Damschroder LJ, Sharifi M. User-Centered Framework for Implementation of Technology (UFIT): Development of an Integrated Framework for Designing Clinical Decision Support Tools Packaged With Tailored Implementation Strategies. J Med Internet Res. 2024 May 21;26:e51952. doi: 10.2196/51952.

    PubMed 38771622
  • Nugent JT, Maciejewski KR, Finn EB, Grout RW, Wood CT, Esserman D, Michel JJ, Lu Y, Sharifi M. High Blood Pressure in Children Aged 3 to 12 Years Old With Overweight or Obesity. Child Obes. 2024 Dec;20(8):581-589. doi: 10.1089/chi.2023.0143. Epub 2024 May 3.

    PubMed 38700557

Questions about this trial

What is this clinical trial studying?

A study testing Improving Pediatric Obesity Practice Using Prompts (iPOP-UP) in people with Obesity, Childhood, run by Yale University at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in BMI as Percentage of 95th Percentile (time frame: Up to 15 months after first primary care visit following trial launch). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05627011, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.

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