DOI: 10.3886/e105184v1-139792
title: Resilient, Empowered, Active Living with Diabetes (REAL)

description: 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).
description: Response Rates: 241 individuals were assessed for eligibility and 81 were randomized to either the intervention (41) or the control (40) group. 71 participants completed follow-up testing. Of the 10 participants who did not complete follow-up testing, nine participants (11.1%) were lost to follow-up, and one participant (1.2%) withdrew from the study, citing a lack of time to complete the study requirements.
description: Presence of Common Scales: Please see the Data Dictionary
description: Eligible participants were adults age 18–30 years old, with a diagnosis of either T1D or T2D for at least 12 months, and a hemoglobin A1C of ≥ 8.0% at the time of study enrollment. Participants were fluent in English or Spanish, were reachable by phone or text message, lived within Los Angeles County with no plans to relocate, and expressed willingness to participate in all study-related activities. While study funds were allocated to provide cell phones with text messaging capability to participants who did not have cell phones or who could not afford the additional cost of calling or text messaging the study team using their personal cell phone, all participants declined this offer. All participants were low in socioeconomic status; initially this was operationalized to mean that the participant had a household income of 138% of Federal Poverty Level or lower. This definition was later expanded to include the following: the participant qualified for income-restricted government entitlement programs (e.g., MediCal/Medicaid, Supplemental Nutrition Assistance Program); the participant had a household income of 250% of Federal Poverty Level or lower; or neither of the participant's parents had attained a four-year college degree.Participants were excluded if they had cognitive disabilities or severe impairments that limited life expectancy; were pregnant or planned a pregnancy within the next 6 months; had participated in a diabetes management intervention beyond diabetes education offered in usual clinic visits totaling ≥ 6 h within the past year; or if they had participated in qualitative research used to inform the development of the REAL Diabetes intervention.
description: face-to-face interview; mixed mode; on-site questionnaire; paper and pencil interview (PAPI); record abstracts; self-enumerated questionnaire;