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Brief Motivational Interviewing to Reduce Child Body Mass Index (BMi2)

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Care
Moderate Dose Motivational Interviewing
Higher Dose Motivational Interviewing
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring Pediatric Obesity, Motivational Interviewing, Overweight, Behavior Change

Eligibility Criteria

2 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Pediatric Research in Office Settings

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Standard Care with Education Materials

Moderate Dose Motivational Interviewing

Higher Dose Motivational Interviewing

Arm Description

Measure height and weight only. usual care

MI delivered by PCP, 4 sessions

MI delivered by PCP, 4 sessions plus MI delivered by RD, 6 sessions

Outcomes

Primary Outcome Measures

Child BMI Percentile

Secondary Outcome Measures

Fruit/Vegetable Consumption
Sweetened Beverage Consumption
Change in Physical Activity

Full Information

First Posted
April 12, 2011
Last Updated
October 11, 2023
Sponsor
University of Michigan
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), American Academy of Pediatrics, Academy of Nutrition and Dietetics, University of Iowa
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1. Study Identification

Unique Protocol Identification Number
NCT01335308
Brief Title
Brief Motivational Interviewing to Reduce Child Body Mass Index
Acronym
BMi2
Official Title
Brief Motivational Interviewing to Reduce Child Body Mass Index
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), American Academy of Pediatrics, Academy of Nutrition and Dietetics, University of Iowa

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Pediatric Obesity, Motivational Interviewing, Overweight, Behavior Change

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
645 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care with Education Materials
Arm Type
Active Comparator
Arm Description
Measure height and weight only. usual care
Arm Title
Moderate Dose Motivational Interviewing
Arm Type
Experimental
Arm Description
MI delivered by PCP, 4 sessions
Arm Title
Higher Dose Motivational Interviewing
Arm Type
Experimental
Arm Description
MI delivered by PCP, 4 sessions plus MI delivered by RD, 6 sessions
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Moderate Dose Motivational Interviewing
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Higher Dose Motivational Interviewing
Intervention Description
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
Primary Outcome Measure Information:
Title
Child BMI Percentile
Time Frame
2 years after recruitment
Secondary Outcome Measure Information:
Title
Fruit/Vegetable Consumption
Time Frame
2 years after enrollment
Title
Sweetened Beverage Consumption
Time Frame
2 years after enrollment
Title
Change in Physical Activity
Time Frame
2 years after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken Resnicow, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Wasserman, MD, MPH
Organizational Affiliation
University of Vermont, American Academy of Pediatrics
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erica Slora, PhD
Organizational Affiliation
American Academy of Pediatrics
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Linda G Snetselaar, PhD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Esther Myers, PhD
Organizational Affiliation
Academy of Nutrition and Dietetics
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fiona McMaster, MA, MPH
Organizational Affiliation
University of Michigan
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alison Bocian, MSc
Organizational Affiliation
American Academy of Pediatrics
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Donna Harris, MA
Organizational Affiliation
American Academy of Pediatrics
Official's Role
Study Director
Facility Information:
Facility Name
Pediatric Research in Office Settings
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36321279
Citation
Woolford SJ, Resnicow K, Davis MM, Nichols LP, Wasserman RC, Harris D, Gebremariam A, Shone L, Fiks AG, Chang T. Cost-effectiveness of a motivational interviewing obesity intervention versus usual care in pediatric primary care offices. Obesity (Silver Spring). 2022 Nov;30(11):2265-2274. doi: 10.1002/oby.23560.
Results Reference
derived
PubMed Identifier
27261549
Citation
Resnicow K, Harris D, Wasserman R, Schwartz RP, Perez-Rosas V, Mihalcea R, Snetselaar L. Advances in Motivational Interviewing for Pediatric Obesity: Results of the Brief Motivational Interviewing to Reduce Body Mass Index Trial and Future Directions. Pediatr Clin North Am. 2016 Jun;63(3):539-62. doi: 10.1016/j.pcl.2016.02.008.
Results Reference
derived
PubMed Identifier
25825539
Citation
Resnicow K, McMaster F, Bocian A, Harris D, Zhou Y, Snetselaar L, Schwartz R, Myers E, Gotlieb J, Foster J, Hollinger D, Smith K, Woolford S, Mueller D, Wasserman RC. Motivational interviewing and dietary counseling for obesity in primary care: an RCT. Pediatrics. 2015 Apr;135(4):649-57. doi: 10.1542/peds.2014-1880.
Results Reference
derived
PubMed Identifier
22434735
Citation
Resnicow K, McMaster F, Woolford S, Slora E, Bocian A, Harris D, Drehmer J, Wasserman R, Schwartz R, Myers E, Foster J, Snetselaar L, Hollinger D, Smith K. Study design and baseline description of the BMI2 trial: reducing paediatric obesity in primary care practices. Pediatr Obes. 2012 Feb;7(1):3-15. doi: 10.1111/j.2047-6310.2011.00001.x. Epub 2011 Dec 13.
Results Reference
derived

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Brief Motivational Interviewing to Reduce Child Body Mass Index

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