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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: Completed NA study, sponsored by University of Michigan.

NCT03177148 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 352 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Differences between intervention and usual care youth at baseline for distance from the 95th percentile for BMI. BMI data from children seen by Usual Care arm pediatric clinicians were matched (3 to 1) to intervention arm children.

Interventions

  • BEHAVIORAL Usual Care
  • BEHAVIORAL Intervention by Clinicians

Trial Details

FieldValue
Enrollment Target 352 participants
Start Date 2017-07-01
Est. Completion 2021-08-31
Phase NA
University of Michigan

1,327 total trials

What the finished NCT03177148 record still lists

NCT03177148 is an interventional study that assigns participants to a tested intervention. The registered 352 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (75% lower).

The record links to 0 conditions, and to 2 interventions - of which Usual Care is the first listed.

NCT03177148 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT03177148's enrollment target sits among peer trials

352 292nd of 2000 higher than 1,709 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03177148, the US trial registry maintained by the National Library of Medicine. NCT03177148 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.