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OpenTrials
Completed

NCT Number: NCT03177148

Population Effects of MI 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.

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Key information

Conditions

Pediatric Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

3 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric Research in Office Settings

Itasca, Illinois, 60143, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Intervention by Clinicians

Behavioral

•Parents will complete surveys after enrollment and at the end of intervention and participate in intervention visits by pediatric clinicians and telephonic counseling with Registered Dietitians (RDs).

Intervention by pediatric clinicians: up to 4 sessions of MI, in-person Intervention by RDs: up to 6 sessions of MI via telephone.

Other names: MI Intervention

Usual Care

Behavioral

Pediatric clinicians provide care as normal

Primary outcomes

  1. Percent Distance From the Sex-age Specific 95th Percentile

    Time frame: Baseline

    Differences between intervention and usual care youth at baseline for distance from the 95th percentile for BMI. BMI data from children seen by Usual Care arm pediatric clinicians were matched (3 to 1) to intervention arm children.

Secondary outcomes

  1. Raw BMI Score

    Time frame: Baseline

    Differences between intervention and usual care youth at baseline for raw BMI score

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • American Academy of Pediatrics
  • Ann & Robert H Lurie Children's Hospital of Chicago
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Population Effects of Motivational Interviewing on Pediatric Obesity in Primary Care

Acronym: BMi2+

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jun 6, 2017
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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