Low income and minority adolescents with type 1 diabetes (T1D) commonly have poor glycemic control and an adverse cardiovascular disease (CVD) risk profile. There is a critical need to develop and test interventions to improve diabetes self-management and health outcomes for these high-risk youth. We propose a pilot and feasibility study of DM-Health, an integrated, evidence-based diabetes self-management intervention that is coherent and user-friendly and takes advantage of state-of-the-art technologies and behavioral strategies. The intervention is based on behavioral approaches (motivational interviewing, problem- solving skills training, and behavioral family systems therapy) and communication technology (cell phone based information exchange);each previously shown by our research team to be efficacious. Participants will be recruited from three clinical sites with demographically diverse patient populations, a variety of provider settings, and established infrastructures for clinical research.
Specific Aims are: 1. Document the feasibility of the DM-Health trial. We will refine strategies for optimal recruitment and retention and establish administrative, central laboratory, data management, and data analysis systems necessary to the efficient execution of a multi-site clinical trial. 2. Determine short-term efficacy and potential effect size of the DM- Health intervention. We will recruit youth (ages 12-16 yr, T1D duration of e1 yr, baseline glycated hemoglobin A1c (A1c) 8.0% - 12.0%) with a goal of at least 70% at high risk based on socio-demographic characteristics (minority race/ethnicity, Medicaid/SCHIP insurance, single-parent household), to participate in a randomized controlled trial (n= 60, 10 intervention and 10 control at each of 3 sites). We will assess primary (A1c) and secondary (CVD risk factors, health-related quality of life) outcomes, as well as potential mediators (diabetes self-management behaviors, family communication patterns, problem solving skills) at baseline and 4 months. 3. Document DM-Health intervention fidelity and acceptability across demographic subgroups and sites. This pilot and feasibility study will inform design of a fully-powered multi-site clinical trial to test the efficacy and potential cost effectiveness of this intervention.
The proposed innovative research takes advantage of cell phones, commonly used by youth, as the means to integrate tools of diabetes self-management with theoretically sound, empirically supported behavioral strategies to improve diabetes outcomes. The work is highly significant and relevant to public health because of the potential for such an intervention to have a substantial impact on both the short- and long-term health outcomes of adolescents with T1D throughout the United States.
| Mayer-Davis, E J; Seid, M; Crandell, J et al. (2015) Flexible Lifestyles for Youth (FL3X) behavioural intervention for at-risk adolescents with Type 1 diabetes: a randomized pilot and feasibility trial. Diabet Med 32:829-33 |
