CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 352 enrolled
Drug / intervention
Intervention by Clinicians +1 morebehavioral
Likely dose
Motivational interviewing: up to 4 in-person sessions with pediatric clinicians plus telephonic counseling with registered dietitiansAI-extracted
Key inclusion· 4
  • Child age 3 to <12 years
  • BMI for age and gender >85th percentile documented in past 12 months
  • Most recent well-child visit with participating study clinician in past 24 months
  • Parent/legal guardian speaks English or Spanish
Key exclusion· 6
  • Child has Type 1 or Type 2 diabetes
  • Child uses growth hormones, SSRIs, or stimulants daily or chronically
  • Child uses atypical antipsychotics
  • Child has chronic, limiting, severe medical disorder (e.g., Down syndrome, cerebral palsy)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03177148
NCT03177148N/ACompleted

Population Effects of Motivational Interviewing on Pediatric Obesity in Primary Care

University of Michigan·interventional·Posted Jun 6, 2017·Updated Jul 16, 2024

In Brief

A clinical study evaluating Intervention by Clinicians and Usual Care for Pediatric Obesity. Completed, enrolled 352 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJun 6, 2017
Enrollment StartJul 1, 2017
Primary CompletionJan 31, 2021
Study CompletionAug 31, 2021
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 9.1 years ago

Interventions

Intervention by Cliniciansbehavioral

•Parents will complete surveys after enrollment and at the end of intervention and participate in intervention visits by pediatric clinicians and telephonic counseling with Registered Dietitians (RDs). Intervention by pediatric clinicians: up to 4 sessions of MI, in-person Intervention by RDs: up to 6 sessions of MI via telephone.

Usual Carebehavioral

Pediatric clinicians provide care as normal