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NCT03177148 · ClinicalTrials.gov registry record · NA
Population Effects of MI on Pediatric Obesity in Primary Care
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 352
- Enrollment target
NCT03177148 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 352 participants.
The verdict
NCT03177148, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 352 participants
- Enrollment target
Study Summary
In this cluster randomized effectiveness trial, pediatric primary care practices will be recruited from the American Academy of Pediatrics' national Pediatric Research in Office Settings (PROS) practice-based research network, as well as the client database of the Physician's Computer Company (PCC) - an Electronic Health Record (EHR) vendor. We will recruit 18 practices. 9 practices will be randomized to the Intervention arm and 9 practices to Usual Care. Intervention arm practices will select 1-2 pediatric clinicians, including pediatricians (PED) and nurse practitioners (NP), to receive in-person training in Motivational Interviewing (MI), behavioral therapy, billing and coding, and study procedures. Usual Care practices will select 1-2 pediatric clinicians to receive billing / coding and study protocol training only, via telephone and webinar; they will be offered in-person MI training at the close of the trial. Around 316 parents of overweight or obese children (BMI \> 85th percentile for age and gender) between 3 and 11 years of age at baseline that are patients of participating Intervention arm clinicians will be enrolled. Over 24 months, these parents may receive up to 4 in-person, MI-based counseling sessions with a trained pediatric clinician and up to 6 telephone counseling sessions with an MI-trained Registered Dietician (RD). There will be no study-specific contact with parents or their children in Usual Care practices during the trial - they will continue to receive usual care. EHR and billing data for all 3-11 year old children within all participating practices will be extracted by PCC to permit determination of the effectiveness of the intervention versus usual care on change in BMI z-score among 3 groups: 1) all eligible children in the Intervention arm), 2) all eligible children whose parent actively participates in the trial , and 3) all 3-11 year old children in all participating practices.
Interventions
- BEHAVIORAL Usual Care
- BEHAVIORAL Intervention by Clinicians
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 352 participants |
| Start Date | 2017-07-01 |
| Est. Completion | 2021-08-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03177148
The ClinicalTrials.gov registry entry for NCT03177148 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 352 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Usual Care is the first listed.
NCT03177148 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03177148 about?
NCT03177148 is a clinical study titled "Population Effects of MI on Pediatric Obesity in Primary Care". In this cluster randomized effectiveness trial, pediatric primary care practices will be recruited from the American Academy of Pediatrics' national Pediatric Research in Office Settings (PROS) practice-based research network, as well as the client database of the Physician's Computer Company (PCC) ...
What is the current status of trial NCT03177148?
This trial is currently completed. It is a NA study. The enrollment target is 352 participants. The study started on 2017-07-01. Estimated completion is 2021-08-31.
What interventions are being tested in trial NCT03177148?
The interventions under investigation include: Usual Care (BEHAVIORAL), Intervention by Clinicians (BEHAVIORAL).
Who is sponsoring clinical trial NCT03177148?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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