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

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.

Study Overview

• Status: Completed
• Conditions: Childhood Obesity
• Intervention / Treatment: Behavioral: Standard Care; Behavioral: Moderate Dose Motivational Interviewing; Behavioral: Higher Dose Motivational Interviewing

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.

• Study Type: Interventional
• Enrollment (Actual): 645
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Elk Grove Village, Illinois, United States, 60007
      • Pediatric Research in Office Settings

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Care with Education Materials; Measure height and weight only. usual care	Behavioral: Standard Care; 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
Experimental: Moderate Dose Motivational Interviewing; MI delivered by PCP, 4 sessions	Behavioral: Moderate Dose Motivational Interviewing; 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
Experimental: Higher Dose Motivational Interviewing; MI delivered by PCP, 4 sessions plus MI delivered by RD, 6 sessions	Behavioral: Higher Dose Motivational Interviewing; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Child BMI Percentile	2 years after recruitment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); University of Iowa; American Academy of Pediatrics; Academy of Nutrition and Dietetics
• Investigators: Principal Investigator: Ken Resnicow, PhD, University of Michigan; Principal Investigator: Richard Wasserman, MD, MPH, University of Vermont, American Academy of Pediatrics; Principal Investigator: Erica Slora, PhD, American Academy of Pediatrics; Principal Investigator: Linda G Snetselaar, PhD, University of Iowa; Principal Investigator: Esther Myers, PhD, Academy of Nutrition and Dietetics; Study Director: Fiona McMaster, MA, MPH, University of Michigan; Study Director: Alison Bocian, MSc, American Academy of Pediatrics; Study Director: Donna Harris, MA, American Academy of Pediatrics

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: April 12, 2011
• First Submitted That Met QC Criteria: April 13, 2011
• First Posted (Estimated): April 14, 2011

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Motivational Interviewing; Overweight; Behavior Change; Pediatric Obesity
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: HL085400; 5R01HL085400 (U.S. NIH Grant/Contract)