Population Effects of MI on Pediatric Obesity in Primary Care (BMi2+)
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|ClinicalTrials.gov Identifier: NCT03177148|
Recruitment Status : Recruiting
First Posted : June 6, 2017
Last Update Posted : September 13, 2017
|Condition or disease||Intervention/treatment|
|Pediatric Obesity||Behavioral: Intervention by Clinicians Behavioral: Usual Care|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||316 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|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||May 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
- BMI z-score at 2 years from baseline [ Time Frame: 2 years from baseline ]A Generalized Linear Mixed Model (GLMM) will be the primary analytic approach where BMI z-score at 2 years amongst eligible youth is the primary outcome, and a 2 level primary independent variable "TX": Usual Care=0, MI Intervention=1, along with baseline BMI z score as a covariate. Potential covariates include: days since baseline, sex, age, and ethnicity. The study employs a nested cohort design, with practices assigned to condition, as such, outcome variables at the individual level are correlated. To control for cluster randomization effects we will utilize SAS/PROC MIXED. For all mixed analyses, practice will be treated as a random effect with TX condition nested in practice. Various autocorrelation structures will be tested, although simple unstructured (un) or variance components (vc) will be used for the random practice effect. Key potential effect modifiers include age, race, and gender and on the provider level, pediatrician vs. family practitioner.
- Effectiveness among patients of study clinicians trained in MI and whose parent actively participates in the intervention [ Time Frame: 2 years from baseline ]Although the primary intention to treat analyses described analytically 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. As indicated, active participation is defined as a parent receiving at least 1 MI counseling session from either a trained clinician or registered dietician. The same GLMM modeling approach discussed above will be employed to test this secondary aim.
- Population level effects [ Time Frame: 2 years from baseline ]To assess the effect of the intervention at the population level, we will employ a Generalized Linear Mixed Model (GLMM) approach, similar to the analytic plan for AIM I, where BMI z-score at 2 years is the DV, and a 2 level primary independent variable "TX": Usual Care=0, MI Training=1, along with baseline BMI z score as a covariate. Data from all age-eligible children in all participating practices will be included in the analysis.
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
|Contact: Kennet Resnicow, Ph.D.||(734) firstname.lastname@example.org|
|Contact: Emerson Delacroix, M.A.C.P.||email@example.com|
|United States, Illinois|
|Pediatric Research in Office Settings||Recruiting|
|Elk Grove Village, Illinois, United States, 60007|
|Contact: Alison Bocian, MSc|