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

This study is currently recruiting participants.
Verified March 2011 by University of Michigan
Sponsor:
Collaborators:
American Academy of Pediatrics
Academy of Nutrition and Dietetics
University of Iowa
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT01335308
First received: April 12, 2011
Last updated: April 13, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Childhood Obesity
Behavioral: Standard Care
Behavioral: Moderate Dose Motivational Interviewing
Behavioral: Higher Dose Motivational Interviewing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Brief Motivational Interviewing to Reduce Child Body Mass Index

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • child BMI percentile [ Time Frame: 1 and 2 years after recruitment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • fruit/vegetable consumption [ Time Frame: 1 and 2 years after enrollment ] [ Designated as safety issue: No ]
  • sweetened beverage consumption [ Time Frame: 1 and 2 years after enrollment ] [ Designated as safety issue: No ]
  • change in physical activity [ Time Frame: 1 and 2 years after enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 650
Study Start Date: October 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Care with Education Materials 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 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 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

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

Ages Eligible for Study:   2 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01335308

Contacts
Contact: Ken Resnicow, PhD 7346470212 kresnic@umich.edu
Contact: Fiona McMaster, MA, MPH 7347309337 fionamcm@umich.edu

Locations
United States, Illinois
Pediatric Research in Office Settings Recruiting
Elk Grove Village, Illinois, United States, 60007
Contact: Alison Bocian, MSc            
Sponsors and Collaborators
University of Michigan
American Academy of Pediatrics
Academy of Nutrition and Dietetics
University of Iowa
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
  More Information

No publications provided by University of Michigan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Ken Resnicow, University of Michigan
ClinicalTrials.gov Identifier: NCT01335308     History of Changes
Other Study ID Numbers: HL085400, 5R01HL085400
Study First Received: April 12, 2011
Last Updated: April 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Pediatric Obesity
Motivational Interviewing
Overweight
Behavior Change

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013