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Randomized Controlled Trial
. 2012 Apr;129(4):e866-73.
doi: 10.1542/peds.2011-2858. Epub 2012 Mar 5.

Clinic-integrated behavioral intervention for families of youth with type 1 diabetes: randomized clinical trial

Tonja R Nansel  1 , Ronald J Iannotti, Aiyi Liu
Affiliations
Randomized Controlled Trial

Clinic-integrated behavioral intervention for families of youth with type 1 diabetes: randomized clinical trial

Tonja R Nansel et al. Pediatrics. 2012 Apr.

Abstract

Objective: To test the effect on diabetes management outcomes of a low-intensity, clinic-integrated behavioral intervention for families of youth with type 1 diabetes.

Methods: Families (n = 390) obtaining care for type 1 diabetes participated in a 2-year randomized clinical trial of a clinic-integrated behavioral intervention designed to improve family diabetes management practices. Measurement of hemoglobin A1c, the primary outcome, was obtained at each clinic visit and analyzed centrally. Blood glucose meter data were downloaded at each visit. Adherence was assessed by using a semistructured interview at baseline, mid-study, and follow-up. Analyses included 2-sample t tests at predefined time intervals and mixed-effect linear-quadratic models to assess for difference in change in outcomes across the study duration.

Results: A significant overall intervention effect on change in glycemic control from baseline was observed at the 24-month interval (P = .03). The mixed-effect model showed a significant intervention by age interaction (P < .001). Among participants aged 12 to 14, a significant effect on glycemic control was observed (P = .009 for change from baseline to 24-month interval; P = .035 for mixed-effect model across study duration), but there was no effect among those aged 9 to 11. There was no intervention effect on child or parent report of adherence; however, associations of change in adherence with change in glycemic control were weak.

Conclusions: This clinic-integrated behavioral intervention was effective in preventing the deterioration in glycemic control evident during adolescence, offering a potential model for integrating medical and behavioral sciences in clinical care.

Trial registration: ClinicalTrials.gov NCT00273286.

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Figures

FIGURE 1
FIGURE 1
Participant flow through study. a Longitudinal analyses include all available data from each subject through withdrawal or study completion.
FIGURE 2
FIGURE 2
HbA1c across study duration by intervention group. A, Full-sample analysis. B, Analysis by age subgroups.
See this image and copyright information in PMC

Comment in

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