Brief Motivational Interviewing to Reduce Child Body Mass Index

NCT ID: NCT01335308

Last Updated: 2023-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 645 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2013-12-31

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.

Conditions

Childhood Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard Care with Education Materials

Measure height and weight only. usual care

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: 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

Moderate Dose Motivational Interviewing

MI delivered by PCP, 4 sessions

Group Type: EXPERIMENTAL

Moderate Dose Motivational Interviewing

Intervention Type: 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

Higher Dose Motivational Interviewing

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

Group Type: EXPERIMENTAL

Higher Dose Motivational Interviewing

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

American Academy of Pediatrics

OTHER

Sponsor Role: collaborator

Academy of Nutrition and Dietetics

OTHER

Sponsor Role: collaborator

University of Iowa

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Ken Resnicow

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ken Resnicow, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Richard Wasserman, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Vermont, American Academy of Pediatrics

Erica Slora, PhD

Role: PRINCIPAL_INVESTIGATOR

American Academy of Pediatrics

Linda G Snetselaar, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Esther Myers, PhD

Role: PRINCIPAL_INVESTIGATOR

Academy of Nutrition and Dietetics

Fiona McMaster, MA, MPH

Role: STUDY_DIRECTOR

University of Michigan

Alison Bocian, MSc

Role: STUDY_DIRECTOR

American Academy of Pediatrics

Donna Harris, MA

Role: STUDY_DIRECTOR

American Academy of Pediatrics

Locations

Pediatric Research in Office Settings

Elk Grove Village, Illinois, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36321279 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27261549 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25825539 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22434735 (View on PubMed)

Other Identifiers

5R01HL085400

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HL085400

Identifier Type: -

Identifier Source: org_study_id