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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Michigan.
Recruitment status was  Recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014