CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 645 enrolled
Drug / intervention
Standard Care +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT01335308N/ACompleted
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Brief Motivational Interviewing to Reduce Child Body Mass Index

University of Michigan·interventional·Posted Apr 14, 2011·Updated Oct 13, 2023

In Brief

A clinical study evaluating Standard Care, Moderate Dose Motivational Interviewing, and 1 other intervention for Childhood Obesity. Completed, enrolled 645 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChildhood Obesity
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), American Academy of Pediatrics, Academy of Nutrition and Dietetics, University of Iowa

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 14, 2011
Enrollment StartOct 1, 2009
Primary CompletionJul 1, 2013
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 15.2 years ago

Interventions

Standard Carebehavioral

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 Interviewingbehavioral

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 Interviewingbehavioral

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