Population Effects of MI on Pediatric Obesity in Primary Care

Pediatric Obesity Clinical Trial

— BMi2+  

Official title:

Population Effects of Motivational Interviewing on Pediatric Obesity in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03177148
• Other study ID #: BMi2+
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: August 31, 2021

Study information

• Verified date: September 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 329
• Est. completion date: August 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 11 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Intervention by Clinicians
PCPs deliver 4 sessions of MI in person, and RDs deliver 6 sessions of MI via telephone. PCPs and RDs will receive 2 days of MI training.
• Usual Care
PCPs provide care as normal

Locations

Country	Name	City	State
United States	Pediatric Research in Office Settings	Itasca	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	American Academy of Pediatrics, Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Population level effects: Effects on all youth of participating providers	To assess the effect of the intervention at the population level, using a similar analytic approach used in AIM I, we will include data from all age-eligible children of all participating practitioners will be included in the analysis, even if the child was not enrolled in the study.	Approximately 2 years from baseline
Primary	Percent distance from the sex-age-specific 95th percentile, on both the linear and log-transform scales.	Recent changes to the evaluation of interventions on body mass index (BMI) necessitates an update to evaluating intervention effects on BMI in children with obesity and overweight in this trial. This research will investigate change in adiposity defined as BMI percent distance from the sex-age-specific 95% percentile, on both the linear scale (for interpretable effect measures) and log-transform scales (to meet required model/distribution assumptions). We will report the analysis results using both measures, one as the primary analysis and the other the sensitivity analysis.	Approximately 2 years from baseline
Secondary	Effectiveness among patients of study clinicians trained in MI and whose parents engage in the intervention (per-protocol analysis)	Although the primary intention to treat analyses described above for primary outcome will include all patients assigned to groups regardless of intervention exposure, as a secondary analysis, we will examine effects among the subsample of children who parents actively participated in the intervention, defined as receipt of at least 50% of the planned MI dose. The same modeling approaches discussed above will be employed to test this secondary aim.	Approximately 2 years from baseline