Clinical trial NCT01335308: Brief Motivational Interviewing to Reduce Child Body Mass Index
Official title: Brief Motivational Interviewing to Reduce Child Body Mass Index
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: Pediatric Obesity
Motivational Interviewing
Overweight
Behavior Change
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: American Academy of Pediatrics
name: Academy of Nutrition and Dietetics
name: University of Iowa
First posted: 2011-04-14
Enrollment: 645
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Child BMI Percentile
timeFrame: 2 years after recruitment
Secondary outcomes:
measure: Fruit/Vegetable Consumption
timeFrame: 2 years after enrollment
measure: Sweetened Beverage Consumption
timeFrame: 2 years after enrollment
measure: Change in Physical Activity
timeFrame: 2 years after enrollment
Other outcomes:
Locations:
city: Elk Grove Village
country: United States
facility: Pediatric Research in Office Settings
state: Illinois
Study officials:
affiliation: University of Michigan
name: Ken Resnicow, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Vermont, American Academy of Pediatrics
name: Richard Wasserman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: American Academy of Pediatrics
name: Erica Slora, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Linda G Snetselaar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Academy of Nutrition and Dietetics
name: Esther Myers, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Fiona McMaster, MA, MPH
role: STUDY_DIRECTOR
affiliation: American Academy of Pediatrics
name: Alison Bocian, MSc
role: STUDY_DIRECTOR
affiliation: American Academy of Pediatrics
name: Donna Harris, MA
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.