Population Effects of MI on Pediatric Obesity in Primary Care (BMi2+)

• ClinicalTrials.gov Identifier: NCT03177148
• Recruitment Status: Completed
• First Posted: June 6, 2017
• Last Update Posted: September 17, 2021
• Sponsor: University of Michigan
• Collaborators: American Academy of Pediatrics; Ann & Robert H Lurie Children's Hospital of Chicago
• Information provided by (Responsible Party): Ken Resnicow, University of Michigan

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pediatric Obesity	Behavioral: Intervention by Clinicians; Behavioral: Usual Care	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 329 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: After two years of intervention arm study, the usual care arm will receive MI training.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Population Effects of Motivational Interviewing on Pediatric Obesity in Primary Care
• Actual Study Start Date: July 1, 2017
• Actual Primary Completion Date: January 31, 2021
• Actual Study Completion Date: August 31, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Usual Care; 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; PCPs provide care as normal
Experimental: Intervention by Clinicians; 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; 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.; Other Name: MI Intervention

Outcome Measures

Primary Outcome Measures :

1. Percent distance from the sex-age-specific 95th percentile, on both the linear and log-transform scales. [ Time Frame: Approximately 2 years from baseline ]
   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.

Secondary Outcome Measures :

1. Effectiveness among patients of study clinicians trained in MI and whose parents engage in the intervention (per-protocol analysis) [ Time Frame: Approximately 2 years from baseline ]
   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.

Other Outcome Measures:

1. Population level effects: Effects on all youth of participating providers [ Time Frame: Approximately 2 years from baseline ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 3 Years to 11 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

United States, Illinois

Pediatric Research in Office Settings

Itasca, Illinois, United States, 60143

Sponsors and Collaborators

University of Michigan

American Academy of Pediatrics

Ann & Robert H Lurie Children's Hospital of Chicago

Investigators

• Principal Investigator: Kenneth Resnicow, Ph.D.; University of Michigan
• Study Director: Emerson Delacroix, M.A.C.P.; University of Michigan

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Ken Resnicow, Professor, Health Behavior & Health Education, University of Michigan
• ClinicalTrials.gov Identifier: NCT03177148
• Other Study ID Numbers: BMi2+
• First Posted: June 6, 2017
• Last Update Posted: September 17, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: An external DSMB will be used. They will meet at least once a year, and will convene as needed to review potential adverse events.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Obesity; Pediatric Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight