View Clinical Trial (Medical Research Study)
Brief Motivational Interviewing to Reduce Child Body Mass Index
| City: |
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Elk Grove Village |
| State: |
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Illinois |
| Zip Code: |
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60007 |
| Conditions: |
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Childhood Obesity |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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)
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| NCT ID: |
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NCT01335308 |
| Primary Contact: |
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Principal Investigator
Ken Resnicow, PhD
University of Michigan
Ken Resnicow, PhD
Phone: 7346470212
Email: kresnic@umich.edu
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| Backup Contact: |
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Email: fionamcm@umich.edu
Fiona McMaster, MA, MPH
Phone: 7347309337
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| Location Contact: |
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Elk Grove Village, Illinois 60007
United States
Alison Bocian, MSc
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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