Population Effects of MI on Pediatric Obesity in Primary Care (BMi2+)
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|ClinicalTrials.gov Identifier: NCT03177148|
Recruitment Status : Completed
First Posted : June 6, 2017
Last Update Posted : September 17, 2021
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Obesity||Behavioral: Intervention by Clinicians Behavioral: Usual Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||329 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||After two years of intervention arm study, the usual care arm will receive MI training.|
|Masking:||None (Open Label)|
|Official Title:||Population Effects of Motivational Interviewing on Pediatric Obesity in Primary Care|
|Actual Study Start Date :||July 1, 2017|
|Actual Primary Completion Date :||January 31, 2021|
|Actual Study Completion Date :||August 31, 2021|
Active Comparator: Usual Care
At the end of the intervention period, 1-2 pediatric clinicians will be offered the in-person MI training and DVD materials
Behavioral: Usual Care
PCPs provide care as normal
Experimental: Intervention by Clinicians
Dietitians will provide up to 6 telephone counseling sessions.
•Parents will complete surveys after enrollment and at the end of intervention
Behavioral: Intervention by Clinicians
PCPs deliver 4 sessions of MI in person, and RDs deliver 6 sessions of MI via telephone. PCPs and RDs will receive 2 days of MI training.
Other Name: MI Intervention
- Percent distance from the sex-age-specific 95th percentile, on both the linear and log-transform scales. [ Time Frame: Approximately 2 years from baseline ]Recent changes to the evaluation of interventions on body mass index (BMI) necessitates an update to evaluating intervention effects on BMI in children with obesity and overweight in this trial. This research will investigate change in adiposity defined as BMI percent distance from the sex-age-specific 95% percentile, on both the linear scale (for interpretable effect measures) and log-transform scales (to meet required model/distribution assumptions). We will report the analysis results using both measures, one as the primary analysis and the other the sensitivity analysis.
- Effectiveness among patients of study clinicians trained in MI and whose parents engage in the intervention (per-protocol analysis) [ Time Frame: Approximately 2 years from baseline ]Although the primary intention to treat analyses described above for primary outcome will include all patients assigned to groups regardless of intervention exposure, as a secondary analysis, we will examine effects among the subsample of children who parents actively participated in the intervention, defined as receipt of at least 50% of the planned MI dose. The same modeling approaches discussed above will be employed to test this secondary aim.
- Population level effects: Effects on all youth of participating providers [ Time Frame: Approximately 2 years from baseline ]To assess the effect of the intervention at the population level, using a similar analytic approach used in AIM I, we will include data from all age-eligible children of all participating practitioners will be included in the analysis, even if the child was not enrolled in the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177148
|United States, Illinois|
|Pediatric Research in Office Settings|
|Itasca, Illinois, United States, 60143|
|Principal Investigator:||Kenneth Resnicow, Ph.D.||University of Michigan|
|Study Director:||Emerson Delacroix, M.A.C.P.||University of Michigan|