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.
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)
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Obesity, Childhood
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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:
- 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.
Measured: 6 months after trial launch
Secondary outcomes (14)
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:
- 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.
Measured: 12 and 18 months after trial launch
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted25 Nov 2022
- Study start9 Feb 2023
- Primary completion14 Dec 2024
- Study completion14 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Mahnoosh (Mona) Sharifi, MD, MPH, Principal investigator, Yale University
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 38771622Nugent 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05627011
- Acronym / sponsor ID
- iPOP-UP / 2000033551
- Conditions
- Obesity, Childhood
- Keywords
- Clinical Decision Support, Implementation Science, Pediatric Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58,364 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 14 Dec 2024 (actual)
- Study completion
- 14 Dec 2024 (actual)
- First posted
- 25 Nov 2022 (actual)
- Results
- Posted 19 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Clinical Decision Support Tool | Experimental | Behavioral: Improving Pediatric Obesity Practice Using Prompts (iPOP-UP)Practices assigned to iPOP-UP intervention which involves EHR-based CDS tools refined through a formative evaluation and user-centered design. |
| 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. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- None - exclusion criteria are purposefully limited in this real-world implementation study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Improving Pediatric Obesity Practice Using Prompts (iPOP-UP)EHR-based CDS tools refined through a formative evaluation and user-centered design process that immediately preceded this study. | Behavioural | Clinical Decision Support Tool |
Primary outcome
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.
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: 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.
14 secondary outcomes
Percent Adherent Visits in Composite Measure of Clinician's Adherence to Clinical Guidelines
Time frame: 12 and 18 months after trial launch
Percent Visits With Inclusion of Diagnosis Code Indicating High BMI in Problem List
Time frame: 6, 12 and 18 months after trial launch
Percent Visits With Inclusion of Diagnosis Code Indicating High BMI in Visit Diagnosis
Time frame: 6, 12 and 18 months after trial launch
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
Percent Adherent Visits in Appropriate Blood Pressure Screening
Time frame: 6, 12 and 18 months after trial launch
Percent Adherent Visits in Structured Documentation of Counseling
Time frame: 6, 12 and 18 months after trial launch
Percent Visits With Follow-up Visit Requested
Time frame: 6, 12 and 18 months after trial launch
Percent Visits With Referral for Further Management of Obesity
Time frame: 6, 12 and 18 months after trial launch
Percent Visits With Weight Loss Medication Orders, if Eligible
Time frame: 6, 12 and 18 months after trial post intervention launch
Percent Visits With Bariatric Surgery Program Referrals, if Eligible
Time frame: 6, 12 and 18 months after trial launch
Percent Change in Potentially Unnecessary Insulin or Thyroid Laboratory Tests Ordered
Time frame: 6, 12 and 18 months after trial launch
Percent Visits With Clinicians' Utilization of the Clinical Decision Support Tools
Time frame: 6, 12 and 18 months following trial launch
Mean Change in Clinicians' Attitudes and Practice Around Managing Elevated BMI in Primary Care
Time frame: baseline and 6 months post intervention launch
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38771622Ray 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.
- Derived from this study: PubMed 38700557Nugent 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.
- Individual participant dataSharing planned: No
Related trials for Obesity, Childhood
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
Not yet recruitingObservational study
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
Pediatric Obesity, Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahnoosh (Mona) Sharifi, MD, MPH principal investigator
Yale University
3 sites in 1 country: see every site and its status.
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.