Dissemination and Implementation of Improving Pediatric Obesity Practice Using Prompts

NCT05627011 | Completed Results

• 2 other identifiers: 20000335515R01MD014853
• Study Type: interventional
• Target: 58,364
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Obesity, Childhood

Keywords

Clinical Decision Support; Implementation Science; Pediatric Obesity

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

  6 months after trial launch

Secondary Outcomes (14)

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

  12 and 18 months after trial launch

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

  6, 12 and 18 months after trial launch

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

  6, 12 and 18 months after trial launch

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

  6, 12 and 18 months after trial launch

• Percent Adherent Visits in Appropriate Blood Pressure Screening

  6, 12 and 18 months after trial launch

Study Arms (2)

Clinical Decision Support Tool

EXPERIMENTAL

Practices assigned to iPOP-UP intervention which involves EHR-based CDS tools refined through a formative evaluation and user-centered design.

Behavioral: Improving Pediatric Obesity Practice Using Prompts (iPOP-UP)

Control

NO INTERVENTION

Practices 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.

Interventions

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.

Clinical Decision Support Tool

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• Yale University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (3)

Eskenazi Health

Indianapolis, Indiana, 46202, United States

Location

Duke University

Durham, North Carolina, 27708, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• 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.

  PMID: 38771622 DERIVED

• 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.

  PMID: 38700557 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mona Sharifi
• Organization: Yale School of Medicine

Mona.Sharifi@yale.edu

203-785-7821

Study Officials

• Mahnoosh (Mona) Sharifi, MD, MPH

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 25, 2022
• Study Start: February 9, 2023
• Primary Completion: December 14, 2024
• Study Completion: December 14, 2024
• Last Updated: March 19, 2026
• Results First Posted: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)