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

This study is currently recruiting participants.
Verified September 2017 by Ken Resnicow, University of Michigan
Sponsor:
ClinicalTrials.gov Identifier:
NCT03177148
First Posted: June 6, 2017
Last Update Posted: September 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
American Academy of Pediatrics
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by (Responsible Party):
Ken Resnicow, University of Michigan
  Purpose
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 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 8 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 3-8 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 3-8 year old children in all participating practices.

Condition Intervention
Pediatric Obesity Behavioral: Intervention by Clinicians Behavioral: Usual Care

Study Type: Interventional
Study Design: 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

Further study details as provided by Ken Resnicow, University of Michigan:

Primary Outcome Measures:
  • BMI z-score at 2 years from baseline [ Time Frame: 2 years from baseline ]
    A Generalized Linear Mixed Model (GLMM) will be the primary analytic approach where BMI z-score at 2 years amongst eligible youth is the primary outcome, and a 2 level primary independent variable "TX": Usual Care=0, MI Intervention=1, along with baseline BMI z score as a covariate. Potential covariates include: days since baseline, sex, age, and ethnicity. The study employs a nested cohort design, with practices assigned to condition, as such, outcome variables at the individual level are correlated. To control for cluster randomization effects we will utilize SAS/PROC MIXED. For all mixed analyses, practice will be treated as a random effect with TX condition nested in practice. Various autocorrelation structures will be tested, although simple unstructured (un) or variance components (vc) will be used for the random practice effect. Key potential effect modifiers include age, race, and gender and on the provider level, pediatrician vs. family practitioner.


Secondary Outcome Measures:
  • Effectiveness among patients of study clinicians trained in MI and whose parent actively participates in the intervention [ Time Frame: 2 years from baseline ]
    Although the primary intention to treat analyses described analytically 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. As indicated, active participation is defined as a parent receiving at least 1 MI counseling session from either a trained clinician or registered dietician. The same GLMM modeling approach discussed above will be employed to test this secondary aim.


Other Outcome Measures:
  • Population level effects [ Time Frame: 2 years from baseline ]
    To assess the effect of the intervention at the population level, we will employ a Generalized Linear Mixed Model (GLMM) approach, similar to the analytic plan for AIM I, where BMI z-score at 2 years is the DV, and a 2 level primary independent variable "TX": Usual Care=0, MI Training=1, along with baseline BMI z score as a covariate. Data from all age-eligible children in all participating practices will be included in the analysis.


Estimated Enrollment: 316
Actual Study Start Date: July 1, 2017
Estimated Study Completion Date: May 31, 2021
Estimated Primary Completion Date: September 30, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years to 8 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 8 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177148


Contacts
Contact: Kennet Resnicow, Ph.D. (734) 904-3888 kresnic@umich.edu
Contact: Emerson Delacroix, M.A.C.P. emmed@umich.edu

Locations
United States, Illinois
Pediatric Research in Office Settings Recruiting
Elk Grove Village, Illinois, United States, 60007
Contact: Alison Bocian, MSc         
Sponsors and Collaborators
University of Michigan
American Academy of Pediatrics
Ann & Robert H Lurie Children's Hospital of Chicago
  More Information

Responsible Party: Ken Resnicow, Professor, Health Behavior & Health Education, University of Michigan
ClinicalTrials.gov Identifier: NCT03177148     History of Changes
Other Study ID Numbers: BMi2+
First Submitted: May 31, 2017
First Posted: June 6, 2017
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Given the minimal risk associated with the intervention, we will utilize an internal DSMB with the addition of two outside members. Drs. Resnicow, Wasserman, and Fiks, will comprise the internal members. In addition Drs. Sarah Barlow and Robert Siegel, who both served on the DSMB for BMI2, will comprise the outside members. The DSMB will meet once to twice per year to review study progress, e.g., recruitment, retention, drop out as well as possible adverse events. We will exclude any study investigators as voting members of the DSMB. The PIs from the University of Michigan and AAP will attend all meetings but will not participate in any voting.

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
Signs and Symptoms