Diabetes Self-Management Lifestyle Intervention for Urban Minority Young Adults
Beth Pyatak PhD, OTR/L, CDCES, FAOTA
Mentors: Anne Peters, Donna Spruijt-Metz, Robin Whittemore
July 2014 to April 2018 | Total funding $456,312
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (K01DK099202) $456,312
This three-year mentored career development award pilot-tested an innovative individually tailored, community-based intervention, Resilient, Empowered, Active Living with Diabetes (REAL), targeting underserved minority young adults with poorly-controlled diabetes. Study outcomes included glycemic control, diabetes self-care behaviors and quality of life, as well as potential intervention mediators. Additionally, a rigorous process evaluation was executed to evaluate intervention implementation and study procedures. It is anticipated that findings from this pilot study will be used to inform a large-scale randomized controlled trial of the REAL intervention. ClinicalTrials.gov: NCT02214641
Pyatak, E. A., Carandang, K., Vigen, C. L., Blanchard, J., Díaz, J., Concha-Chavez, A., Sequeira, P. A., Wood, J. R., Whittemore, R., Spruijt-Metz, D., & Peters, A. L. (2018). 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(4), 696-704. https://doi.org/10.2337/dc17-1634 Show abstract
Objective. To assess the efficacy of a manualized occupational therapy (OT) intervention (Resilient, Empowered, Active Living with Diabetes [REAL Diabetes]) to improve glycemic control and psychosocial well-being among ethnically diverse young adults with low socioeconomic status (SES) who have type 1 or type 2 diabetes.
Research Design and Methods. Eighty-one young adults (age 22.6 ± 3.5 years; 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 seven 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 (QOL), diabetes distress, depressive symptoms, and life satisfaction. Change scores were analyzed using Wilcoxon rank sum tests.
Results. Intent-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 QOL (+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 with CG participants. There was no statistically significant effect modification by sex, ethnicity, diabetes type, recruitment site, or SES. No study-related serious adverse events were reported.
Conclusions. The REAL Diabetes intervention improved blood glucose control and diabetes-related QOL among a typically hard-to-reach population, thus providing evidence that a structured OT intervention may be beneficial in improving both clinical and psychosocial outcomes among individuals with diabetes.
Carandang, K. M., & Pyatak, E. A. (2018). Feasibility of a manualized occupation-based diabetes management intervention. American Journal of Occupational Therapy, 72(2), 7202345040p1–7202345040p6. https://doi.org/10.5014/ajot.2018.021790 Show abstract
Objective. We investigated the feasibility and acceptability of an occupational therapy intervention targeting diabetes management for underserved young adults.
Method. Eight participants completed the intervention and a battery of assessments at baseline and after the intervention. At completion, the participants and occupational therapist were interviewed about their experiences with the study. Four categories of assessment questions were used to guide the study: process, resource, management, and scientific.
Results. Successes included recruitment; fulfillment of tasks by staff and partnering clinics; adequate space, financial support, and equipment; and meaningfulness of the intervention for participants. Challenges included scheduling participants for the intervention and follow-up focus groups and providing client centeredness and flexibility while reducing burden on the intervener.
Conclusion. This feasibility study allowed us to make necessary revisions to our study protocol before implementing a larger pilot study.
Vigen, C. L., Carandang, K., Blanchard, J., Sequeira, P. A., Wood, J. R., Spruijt-Metz, D., Whittemore, R., Peters, A. L., & Pyatak, E. A. (2018). Psychosocial and behavioral correlates of A1C and quality of life among young adults with diabetes. The Diabetes Educator, 44(6), 489–500. https://doi.org/10.1177/0145721718804170 Show abstract
Purpose. The purpose of this study was to evaluate relationships between behavioral and psychosocial constructs, A1C, and diabetes-dependent quality of life (DQoL) among low-socioeconomic status, ethnically diverse young adults with diabetes.
Methods. Using baseline data of 81 participants in the Resilient, Empowered, Active Living (REAL) randomized controlled trial, behavioral, cognitive, affective, and experiential variables were correlated with A1C and DQoL while adjusting for demographic characteristics, and these relationships were examined for potential effect modification.
Results. The data indicate that depressive symptoms and satisfaction with daily activities are associated with both A1C and DQoL, while diabetes knowledge and participation in daily activities are associated with neither A1C nor DQoL. Two constructs, diabetes distress and life satisfaction, were associated with DQoL and were unrelated to A1C, while 2 constructs, self-monitoring of blood glucose and medication adherence, were associated with A1C but unrelated to DQoL. These relationships were largely unchanged by adjusting for demographic characteristics, while numerous effect modifications were found.
Conclusion. The data suggest that when tailoring interventions, depressive symptoms and satisfaction with daily activities may be particularly fruitful intervention targets, as they represent modifiable risk factors that are associated with both A1C and DQoL.
Pyatak, E. A., Carandang, K., Vigen, C., Blanchard, J., Sequeira, P. A., Wood, J. R., Spruijt-Metz, D., Whittemore, R., & Peters, A. L. (2017). 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, 8-17. https://doi.org/10.1016/j.cct.2016.12.025 Show abstract
Overview. This paper describes the study protocol used to evaluate the Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) intervention and reports on baseline characteristics of recruited participants. REAL Diabetes is an activity-based intervention designed to address the needs of young adults diagnosed with type 1 (T1D) or type 2 diabetes (T2D) from low socioeconomic status or racial/ethnic minority backgrounds. The REAL intervention incorporates tailored delivery of seven content modules addressing various dimensions of health and well-being as they relate to diabetes, delivered by a licensed occupational therapist.
Methods. In this pilot randomized controlled trial, participants are assigned to the REAL Diabetes intervention or an attention control condition. The study's primary recruitment strategies included in-person recruitment at diabetes clinics, mass mailings to clinic patients, and social media advertising. Data collection includes baseline and 6-month assessments of primary outcomes, secondary outcomes, and hypothesized mediators of intervention effects, as well as ongoing process evaluation assessment to ensure study protocol adherence and intervention fidelity.
Results. At baseline, participants (n=81) were 51% female, 78% Latino, and on average 22.6years old with an average HbA1c of 10.8%. A majority of participants (61.7%) demonstrated clinically significant diabetes distress and 27.2% reported symptoms consistent with major depressive disorder. Compared to participants with T1D, participants with T2D had lower diabetes-related self-efficacy and problem-solving skills. Compared to participants recruited at clinics, participants recruited through other strategies had greater diabetes knowledge but weaker medication adherence.
Discussion. Participants in the REAL study demonstrate clinically significant medical and psychosocial needs.
Pyatak, E. A., Carandang, K., & Davis, S. (2015). Developing a manualized occupational therapy diabetes management intervention: Resilient, Empowered, Active Living With Diabetes. OTJR: Occupation, Participation and Health, 35(3), 187-194. https://doi.org/10.1177/1539449215584310 Show abstract
This article reports on the development of a manualized occupational therapy intervention for diabetes management. An initial theoretical framework and core content areas for a Stage 1 intervention manual were developed based on an in-depth needs assessment and review of existing literature. After evaluation by a panel of experts and completion of a feasibility study, the intervention was revised into a Stage 2 manual in preparation for a randomized study evaluating the intervention's efficacy. In developing the initial manual, we delineated core theoretical principles to allow for flexible application and tailoring of the intervention's content areas. Expert panel feedback and feasibility study results led to changes to the intervention structure and content as we developed the Stage 2 manual. Through describing this process, we illustrate the dynamic evolution of intervention manuals, which undergo revisions due to both theoretical and practical considerations at each stage of the research-to-clinical practice pipeline.