Brief Motivational Interviewing to Reduce Child Body Mass Index (BMi2)
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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 |
- child BMI percentile [ Time Frame: 1 and 2 years after recruitment ] [ Designated as safety issue: No ]
- 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 |
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| Contact: Ken Resnicow, PhD | 7346470212 | kresnic@umich.edu |
| Contact: Fiona McMaster, MA, MPH | 7347309337 | fionamcm@umich.edu |
| United States, Illinois | |
| Pediatric Research in Office Settings | Recruiting |
| Elk Grove Village, Illinois, United States, 60007 | |
| Contact: Alison Bocian, MSc | |
| 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