Population Effects of MI on Pediatric Obesity in Primary Care

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.

Conditions

• Pediatric Obesity

Interventions

BEHAVIORAL

Intervention by Clinicians

•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.

BEHAVIORAL

Usual Care

Pediatric clinicians provide care as normal

Sponsors & Collaborators

• American Academy of Pediatrics

  collaborator OTHER

• Ann & Robert H Lurie Children's Hospital of Chicago

  collaborator OTHER

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• University of Michigan

  lead OTHER

Principal Investigators

• Kenneth Resnicow, Ph.D. · University of Michigan

• Emerson Delacroix, M.A.C.P. · University of Michigan

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

3 Years

Max Age

11 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-07-01

Primary Completion

2021-01-31

Completion

2021-08-31

Countries

• United States

Study Locations