Resilient, Empowered, Active Living with Diabetes (REAL)

This three-year study pilot-tested an innovative intervention, Resilient, Empowered, Active Living with Diabetes (REAL), targeting underserved minority young adults with poorly-controlled diabetes. The individually tailored, community-based intervention merged findings of an in-depth needs assessment, principles of an evidence-based <b>occupational therapy </b>intervention (Lifestyle Redesign®) and evidence-based diabetes self-management strategies. A proof-of-concept study demonstrated that REAL is feasible to implement, acceptable to young adults with type 1 diabetes and type 2 diabetes, and has potential to produce positive changes in diabetes self-care and glycemic control. <br> <b>Specific Aims and Hypotheses:</b> <br><b>Aim 1</b>. Determine the intervention's efficacy for the primary outcomes: glycemic control and diabetes self-care. Hypothesis: At 6 months (immediately following the intervention), intervention group participants will demonstrate improvements in A1C and diabetes self-care as compared to control group participants. <br><b>Aim 2</b>. Conduct exploratory analyses of the intervention's impact on secondary outcomes and potential mediating mechanisms (to inform power estimates for a large-scale RCT). Hypothesis 1: At 6 months, intervention group participants will demonstrate improvements in secondary outcomes: diabetes-related stress and quality of life, depression, and life satisfaction as compared to control group participants. Hypothesis 2: At 6 months, intervention group participants will demonstrate improvements in potential mediators of the intervention: habit strength, problem solving, activity participation, self-efficacy and diabetes knowledge as compared to baseline. <br><b>Aim 3</b>. Conduct a process evaluation utilizing mixed methods to evaluate and refine intervention delivery (e.g. <b>treatment</b> fidelity, patient satisfaction) and study procedures (e.g. recruitment, retention, testing protocol). <br><b>Research Design and Methods: </b>Eighty-one young adults (age=22.6 ± 3.5 yrs; hemoglobin A1c (HbA1c)=10.8%/95 mmol/mol ± 1.9%/20.8 mmol/mol) were randomly assigned to the REAL Diabetes intervention group (IG) or an attention control group (CG) over 6 months. IG participants received biweekly sessions guided by a manual composed of 7 content modules; CG participants received standardized educational materials and biweekly phone calls. Blinded assessors collected data at baseline and 6 months. The primary outcome was HbA1c; secondary outcomes included diabetes self-care, diabetes-related quality of life, diabetes distress, depressive symptoms, and life satisfaction. Change scores were analyzed using Wilcoxon rank sum tests. <br> <b>Results:</b> Intention-to-treat analyses showed that IG participants showed significant improvement in HbA1c (-0.57%/6.2 mmol/mol vs. +0.36%/3.9 mmol/mol, p=0.01), diabetes-related quality of life (+0.7 vs. +0.15, p=0.04), and habit strength for checking blood glucose (+3.9 vs. +1.7, p=0.05) as compared to CG participants. There was no statistically significant effect modification by gender, ethnicity, diabetes type, recruitment site, or SES. No study-related serious adverse events were reported. <br><b>Conclusions:</b> The REAL Diabetes intervention improves blood glucose control and diabetes-related quality of life among a typically hard-to-reach population. This study provides the most methodologically rigorous evidence to date that occupational therapy improves both clinical and psychosocial outcomes among individuals with diabetes. <br> <br>This work was supported by the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health (NIH/NIDDK #1K01 DK099202-01A1).