- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03177148
Population Effects of MI on Pediatric Obesity in Primary Care (BMi2+)
September 10, 2021 updated by: Ken Resnicow, University of Michigan
Population Effects of Motivational Interviewing on Pediatric Obesity in Primary Care
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
329
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Itasca, Illinois, United States, 60143
- Pediatric Research in Office Settings
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 11 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Usual Care
At the end of the intervention period, 1-2 pediatric clinicians will be offered the in-person MI training and DVD materials |
PCPs provide care as normal
|
Experimental: Intervention by Clinicians
Dietitians will provide up to 6 telephone counseling sessions. •Parents will complete surveys after enrollment and at the end of intervention |
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Approximately 2 years from baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Approximately 2 years from baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Approximately 2 years from baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Emerson Delacroix, M.A.C.P., University of Michigan
- Principal Investigator: Kenneth Resnicow, Ph.D., University of Michigan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2017
Primary Completion (Actual)
January 31, 2021
Study Completion (Actual)
August 31, 2021
Study Registration Dates
First Submitted
May 31, 2017
First Submitted That Met QC Criteria
May 31, 2017
First Posted (Actual)
June 6, 2017
Study Record Updates
Last Update Posted (Actual)
September 17, 2021
Last Update Submitted That Met QC Criteria
September 10, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BMi2+
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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.
IPD Sharing 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.
IPD Sharing Access Criteria
DSMB members and study team members have access to the data and results of the study.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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