Clinic-Integrated Behavioral Intervention for Families of Youth With Type 1 Diabetes: Randomized Clinical Trial
Nansel TR et al. – 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.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.
- 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.