Brief Motivational Interviewing to Reduce Child Body Mass Index

Study Overview
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Brief Summary
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BMi 2 is a study that tests a behavioral counseling approach to reduce obesity in children. Practitioners (Pediatricians, Nurse Practitioners) were randomly assigned to one of three groups. The first group continued with standard care; in group 2, each practitioner delivered four study Motivational Interviewing visits with the parent/caregiver, and in group 3 in addition to the practitioner, a registered dietitian delivered 6 Motivational Interviewing visits. The primary outcome will be the child's percentile BMI change between the baseline and 2-year follow-up. Secondary outcomes will include behavior change around fruits and vegetables, sweetened beverages and exercise. Our hypothesis is that there will be a larger decrease in BMI percentile for children in group 3 than in group 2, and that children in group 2 will have a decrease in BMI percentile when compared to group one.

Detailed Description
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The study is a cluster-randomized intervention trial with clinical practices serving as the unit of randomization and analysis. The investigators are testing two increasingly intensive interventions compared to a minimal intensity/Usual Care Group. Group 1 (Usual Care) includes determination of BMI percentile at baseline, 1-year, and 2-year follow-up. Usual Care (UC) practitioners provide parents with educational materials and routine care. UC pediatricians and their study staff received a ½ day study orientation session which included a brief CME-type workshop addressing obesity treatment.. Group 2 (Pediatric Practitioner only) includes the same assessment points as UC. In addition, Group 2 Pediatric Practitioners (PPs) received 2 days of in-person training in Motivational Interviewing (MI) and Behavior Therapy (BT) as well as an interactive DVD MI booster training system focusing on pediatric obesity. PPs in Group 2 are asked to schedule 3 proactive counseling sessions with a parent of the index child in Year 1 and one additional booster visit in year 2. To guide their counseling they are provided with a food and activity screening tool. In addition, Group 2 practices are provided with educational materials written in a style consistent with Motivational Interviewing and Self Determination Theory. Unlike in Group 1, where all of the educational materials are provided proactively to each parent, in Groups 2 and 3, materials are distributed on a more selective tailored basis depending on parent needs. Group 3 (PP+RD) includes the same intervention components as Group 2, but adds MI-based counseling from a trained and registered dietitian (RD) who is linked to that practice. RDs deliver 6 MI-based counseling sessions over 2 years. The intervention is front loaded with 4 sessions in Year 1 and the remaining 2 in Year 2. The RD sessions are delivered both in-person (required for visit 1) and optionally by telephone or in-person, subsequently. Similar to MDs, RDs received 2.0 days of in-person MI and BT training, and the interactive DVD MI booster training system.

Official Title
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Brief Motivational Interviewing to Reduce Child Body Mass Index

Conditions
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Childhood Obesity

Intervention / Treatment
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* Behavioral: Standard Care
* Behavioral: Moderate Dose Motivational Interviewing
* Behavioral: Higher Dose Motivational Interviewing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 85th - 97th percentile BMI parent/care giver ability to converse in English working telephone Exclusion Criteria: child under current subspecialty care for overweight/obesity child currently taking weight-altering medication (at enrollment)

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Care with Education Materials<br>Measure height and weight only. usual care | Behavioral: Standard Care<br>* Practitioners will receive 2 hour obesity lecture and ½ day protocol training. Families recruited are given parent education materials. Outcomes will be collected at 1 year and 2 years after enrollment<br>|
| Experimental: Moderate Dose Motivational Interviewing<br>MI delivered by PCP, 4 sessions | Behavioral: Moderate Dose Motivational Interviewing<br>* Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner. Outcomes will be collected at 1 year and 2 years after enrollment<br>|
| Experimental: Higher Dose Motivational Interviewing<br>MI delivered by PCP, 4 sessions plus MI delivered by RD, 6 sessions | Behavioral: Higher Dose Motivational Interviewing<br>* Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner and 6 x visits (in phone or in person) with a Registered Dietitian, also trained in Motivational Interviewing. Outcomes will be collected at 1 year and 2 years after enrollment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child BMI Percentile |  | 2 years after recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fruit/Vegetable Consumption |  | 2 years after enrollment | 
| Sweetened Beverage Consumption |  | 2 years after enrollment | 
| Change in Physical Activity |  | 2 years after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric Obesity, Motivational Interviewing, Overweight, Behavior Change