Brief Motivational Interviewing to Reduce Child Body Mass Index

NCT01335308 | Completed Results DMC

• 2 other identifiers: HL0854005R01HL085400
• Study Type: interventional
• Target: 645
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity

Keywords

Pediatric Obesity; Motivational Interviewing; Overweight; Behavior Change

Outcome Measures

Primary Outcomes (1)

• Child BMI Percentile

  2 years after recruitment

Secondary Outcomes (3)

• Fruit/Vegetable Consumption

  2 years after enrollment

• Sweetened Beverage Consumption

  2 years after enrollment

• Change in Physical Activity

  2 years after enrollment

Study Arms (3)

Standard Care with Education Materials

ACTIVE COMPARATOR

Measure height and weight only. usual care

Behavioral: Standard Care

Moderate Dose Motivational Interviewing

EXPERIMENTAL

MI delivered by PCP, 4 sessions

Behavioral: Moderate Dose Motivational Interviewing

Higher Dose Motivational Interviewing

EXPERIMENTAL

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

Behavioral: Higher Dose Motivational Interviewing

Interventions

Standard Care BEHAVIORAL

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

Standard Care with Education Materials

Moderate Dose Motivational Interviewing BEHAVIORAL

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

Moderate Dose Motivational Interviewing

Higher Dose Motivational Interviewing BEHAVIORAL

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

Higher Dose Motivational Interviewing

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• th - 97th percentile BMI
• parent/care giver ability to converse in English
• working telephone

You may not qualify if:

• child under current subspecialty care for overweight/obesity
• child currently taking weight-altering medication (at enrollment)

Sponsors & Collaborators

• University of Michigan: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• American Academy of Pediatrics: collaborator
• Academy of Nutrition and Dietetics: collaborator
• University of Iowa: collaborator

Study Sites (1)

Pediatric Research in Office Settings

Elk Grove Village, Illinois, 60007, United States

Location

Related Publications (4)

• 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.

  PMID: 36321279 DERIVED

• 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.

  PMID: 27261549 DERIVED

• 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.

  PMID: 25825539 DERIVED

• 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.

  PMID: 22434735 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Overweight

Interventions

Standard of Care; Motivational Interviewing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Ken Resnicow
• Organization: University of Michigan

kresnic@umich.edu

734 647 0212

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 12, 2011
• First Posted: April 14, 2011
• Study Start: October 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 13, 2023
• Results First Posted: June 27, 2017

Record last verified: 2023-10

Locations

US (1)