Clinical trial NCT03177148: Population Effects of MI on Pediatric Obesity in Primary Care
Official title: Population Effects of Motivational Interviewing on Pediatric Obesity in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: American Academy of Pediatrics
name: Ann & Robert H Lurie Children's Hospital of Chicago
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-06-06
Enrollment: 352
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: After two years of intervention arm study, the usual care arm will receive MI training.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Percent Distance From the Sex-age Specific 95th Percentile
timeFrame: Baseline
Secondary outcomes:
measure: Raw BMI Score
timeFrame: Baseline
Other outcomes:
Locations:
city: Itasca
country: United States
facility: Pediatric Research in Office Settings
state: Illinois
Study officials:
affiliation: University of Michigan
name: Kenneth Resnicow, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Emerson Delacroix, M.A.C.P.
role: STUDY_DIRECTOR
References:
citation: 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.