Population Effects of MI on Pediatric Obesity in Primary Care

NCT03177148 | Completed Results DMC

• 2 other identifiers: BMi2+5R01HL128231-05
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Percent Distance From the Sex-age Specific 95th Percentile

  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.

  Baseline

Secondary Outcomes (1)

• Raw BMI Score

  Baseline

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

* 1-2 pediatric clinicians per practice will be trained in study procedures, current obesity treatment guidelines, and obesity billing and coding via telephone and webinar * NO active enrollment of parents * Secure extraction of HIPAA limited Electronic Health Record (EHR) and billing data from practices for outcomes analyses At the end of the intervention period, 1-2 pediatric clinicians will be offered the in-person MI training and DVD materials

Behavioral: Usual Care

Intervention by Clinicians

EXPERIMENTAL

* Pediatric Clinicians complete surveys during enrollment and end of the intervention * 1-2 clinicians from each practice will receive 2.5 days of in-person MI training, two scored encounters with a standardized patient, and an interactive DVD MI booster training system focusing on pediatric obesity. * Enroll 35 eligible parents per practice * Clinicians give up to 4 in-person, MI sessions to enrolled parents over 2 years. Dietitians will provide up to 6 telephone counseling sessions. •Parents will complete surveys after enrollment and at the end of intervention

Behavioral: Intervention by Clinicians

Interventions

Intervention by Clinicians BEHAVIORAL

•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.

Also known as: MI Intervention

Intervention by Clinicians

Usual Care BEHAVIORAL

Pediatric clinicians provide care as normal

Usual Care

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• For Practices: Currently use Physician's Computer Company (PCC) as their Electronic Health Record (EHR) vendor
• For Clinicians: Have been employed by the practice for at least 1 year on or before July 1, 2017 Work \> half time (at least 6 sessions per week)
• For Parents: Parent or legal guardian of a child that meets the following criteria: At least 3 but not yet 12 years of age on the date of the baseline data pull (estimated to occur in the summer or fall of 2017). BMI for age and gender \> 85th percentile - documented at an office visit that occurred during the 12 months prior to the baseline data pull. Most recent well-child visit was with a participating study clinician during the 24 months prior to the baseline data pull

You may not qualify if:

• For Practices: Offer a comprehensive weight loss program or access to a RD at or through the practice. Unable or unwilling to send all participating study clinicians to in-person training.Unable or unwilling to identify and assign a study coordinator for the study
• For Clinicians: \> 1 day of prior training in MI within the past 10 years. Prior participation in the AAP/PROS Healthy Lifestyles Pilot Study (HLS; AAP IRB protocol # 01SC01) or Brief Motivational Interviewing to Reduce Body Mass Index (BMI2) Study (AAP IRB protocol # 07RE01).
• For Parents: Does not speak either English or Spanish. Parent or legal guardian of a child who has any of the following documented in their EHR: Type I or Type II diabetes. Daily or chronic use of medications known to affect growth and mood / behavior (growth hormones, SSRIs, stimulants).Use of atypical antipsychotics. A chronic, limiting, severe medical disorder, syndrome, or other condition (e.g., Downs syndrome, cerebral palsy)

Sponsors & Collaborators

• University of Michigan: lead
• American Academy of Pediatrics: collaborator
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Pediatric Research in Office Settings

Itasca, Illinois, 60143, United States

Location

Related Publications (1)

• Wright ME, Delacroix E, Sonneville KR, Considine S, Proctor T, Steffes J, Harris D, Shone LP, Woo H, Vaughan R, Grundmeier RW, Fiks AG, Stockwell MS, Resnicow K. Reducing paediatric overweight and obesity through motivational interviewing: study protocol for a randomised controlled trial in the AAP PROS research network. BMJ Open. 2020 Jul 28;10(7):e035720. doi: 10.1136/bmjopen-2019-035720.

  PMID: 32723736 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mx. Emerson Delacroix
• Organization: University of Michigan

emmed@med.umich.edu

734-764-2014

Study Officials

• Kenneth Resnicow, Ph.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Emerson Delacroix, M.A.C.P.

  University of Michigan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Health Behavior & Health Education

Model Details: After two years of intervention arm study, the usual care arm will receive MI training.

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 6, 2017
• Study Start: July 1, 2017
• Primary Completion: January 31, 2021
• Study Completion: August 31, 2021
• Last Updated: July 16, 2024
• Results First Posted: July 16, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The study teams at University of Michigan and the American Academy of Pediatrics disseminate the protocol with any deviations or adverse events to the external DSMB for their annual meeting, and at the conclusion of the study. Data will be de-identified after the intervention phase ends which is planned for May 2021.
• Access Criteria: DSMB members and study team members have access to the data and results of the study.

Locations

US (1)