Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03177148
Study type Interventional
Source University of Michigan
Contact
Status Completed
Phase N/A
Start date July 1, 2017
Completion date August 31, 2021

See also
  Status Clinical Trial Phase
Not yet recruiting NCT03994419 - PErioperAtive CHildhood ObesitY
Recruiting NCT06111040 - Nurturing Needs Study: Parenting Food Motivated Children N/A
Completed NCT03036696 - The BEACH Interview Study- Pregnant and Breastfeeding Mothers
Not yet recruiting NCT02484612 - Exercise Intensity and Appetite in Adolescents N/A
Completed NCT02959034 - Pediatric Metabolism and Microbiome Repository
Completed NCT02545764 - Training Induced Reduction of Lower-limb Joint Loads During Locomotion in Obese Children N/A
Recruiting NCT02426346 - A Scalable Weight Control Intervention for Adolescents Phase 2
Completed NCT02160847 - Development of the DRIVE Curriculum to Address Childhood Obesity Risk Factors N/A
Completed NCT01989065 - Healthy Lifestyles Program for You (HLP4U): Augmenting Childhood Obesity Treatment. N/A
Completed NCT02343588 - A National School-based Health Lifestyles Interventions Among Chinese Children and Adolescents Against Obesity N/A
Completed NCT02375490 - Healthy Start to Increase Physical Activity and Improve Healthy Eating in Early Childcare Centres N/A
Completed NCT01908153 - Taste Reward Processing in Pediatric Obesity
Completed NCT02074332 - Study on Obesity Intervention With Physical Exercise Among Students in Changping District, Beijing N/A
Completed NCT02086851 - Study of a Structured Parent Intervention on Adolescent Weight Loss Modification Program. N/A
Completed NCT01146314 - A Family Based Intervention to Reduce the Risk of Type 2 Diabetes in Children N/A
Terminated NCT00846521 - Study of Post-meal Blood Sugar Peaks in Association With Vascular Disease in Childhood Obesity Phase 4
Completed NCT04164277 - FirstStep2Health Intervention N/A
Withdrawn NCT04600648 - Sweet Taste Responsiveness in Relation to Insulin, Leptin and Adiposity Among Obese Treatment Seeking Children N/A
Completed NCT04395430 - A Novel School-clinic-community Online Model of Child Obesity Treatment in Singapore During COVID-19 N/A
Completed NCT03139877 - Pediatric Obesity Observational Prospective Trial