Resilient, Empowered, Active Living with Diabetes (REAL)
- Pyatak, Elizabeth (University of Southern California)
National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health
- Award Number: 1K01 DK099202-01A1
AbstractThis 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 occupational therapy 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.
Specific Aims and Hypotheses:
Aim 1. 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.
Aim 2. 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.
Aim 3. Conduct a process evaluation utilizing mixed methods to evaluate and refine intervention delivery (e.g. treatment fidelity, patient satisfaction) and study procedures (e.g. recruitment, retention, testing protocol).
Research Design and Methods: 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.
Results: 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.
Conclusions: 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.
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).
Technical InformationResponse 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.
Technical InformationPresence of Common Scales: Please see the Data Dictionary
2014-10-01 / 2016-08-31Collection Date(s): Wed Oct 01 00:00:00 EDT 2014--Wed Aug 31 00:00:00 EDT 2016
Los Angeles, CA
face-to-face interview; mixed mode; on-site questionnaire; paper and pencil interview (PAPI); record abstracts; self-enumerated questionnaire;
Is cited by
DOI: 10.2337/dc17-1634 (Text)
Is cited by
DOI: 10.1016/j.cct.2016.12.025 (Text)
Pyatak, Elizabeth A., Kristine Carandang, Cheryl L.P. Vigen, Jeanine Blanchard, Jesus Diaz, Alyssa Concha-Chavez, Paola A. Sequeira, et al. “Occupational Therapy Intervention Improves Glycemic Control and Quality of Life Among Young Adults With Diabetes: The Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) Randomized Controlled Trial.” Diabetes Care 41, no. 4 (January 19, 2018): 696–704.
- ID: 10.2337/dc17-1634 (DOI)
Pyatak, Elizabeth A., Kristine Carandang, Cheryl Vigen, Jeanine Blanchard, Paola A. Sequeira, Jamie R. Wood, Donna Spruijt-Metz, Robin Whittemore, and Anne L. Peters. “Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) Study: Methodology and Baseline Characteristics of a Randomized Controlled Trial Evaluating an Occupation-Based Diabetes Management Intervention for Young Adults.” Contemporary Clinical Trials 54 (March 1, 2017): 8–17.
- ID: 10.1016/j.cct.2016.12.025 (DOI)
Update Metadata: 2020-06-28 | Issue Number: 1 | Registration Date: 2020-06-28