Design and Methods for a Comparative Effectiveness Pilot Study: Virtual World vs. Face-to-Face Diabetes Self-Management

BACKGROUND: Type 2 diabetes (diabetes) is a serious threat to public health in the United States and disproportionally affects many racial/ethnic minority groups, including African Americans. Limited access to treatment and high attrition rates further contribute to health disparities in diabetes-related morbidity and mortality among minorities. Greater opportunities for increasing access and decreasing barriers to treatment are needed. Technology-based interventions have potential for accomplishing this goal but evidence of feasibility and potential effectiveness is lacking, especially for populations that traditionally have limited educational attainment and low computer literacy. OBJECTIVE: This paper describes the design and methods of a pilot randomized clinical trial that will compare the feasibility and potential efficacy of delivering a diabetes self-management intervention via a virtual world vs. a face-to-face format. METHODS: Study participants (n=100) will be African American women with uncontrolled type 2 diabetes recruited from primary care practices and affiliated health centers at a large safety net hospital in Massachusetts. Participants will be randomized into a virtual world-based (VW) intervention condition or a face-to-face control condition. Both conditions provide the same theory-based curriculum and equivalent exposure to the self-management program (eight group sessions), and both will be delivered by a single intervention team (a dietitian and a diabetes educator). Assessments will be conducted at baseline and 4 months. Feasibility will be determined by evaluating the degree to which participants engage in the VW-based intervention compared to face to face (number of sessions completed). Potential efficacy will be determined by comparing change in physiological (glycemic control) and behavioral (self-reported dietary intake, physical activity, blood glucose self-monitoring, and medication adherence) outcomes between the experimental and control groups. RESULTS: The primary outcomes of interest are feasibility of the VW intervention and its potential efficacy on glucose control and diabetes self-management behaviors, compared to the face-to-face condition. Analysis will use a two-sample Kolmogorov-Smirnov test for changes in variable distribution. P values will be calculated using binomial tests for proportions and t tests for continuous variables. CONCLUSIONS: If the intervention is found to be feasible and promising, it will be tested in a larger RCT

A Virtual World Versus Face-to-Face Intervention Format to Promote Diabetes Self-Management Among African American Women: A Pilot Randomized Clinical Trial

BACKGROUND: Virtual world environments have the potential to increase access to diabetes self-management interventions and may lower cost. OBJECTIVE: We tested the feasibility and comparative effectiveness of a virtual world versus a face-to-face diabetes self-management group intervention. METHODS: We recruited African American women with type 2 diabetes to participate in an 8-week diabetes self-management program adapted from Power to Prevent, a behavior-change in-person group program for African Americans with diabetes or pre-diabetes. The program is social cognitive theory-guided, evidence-based, and culturally tailored. Participants were randomized to participate in the program via virtual world (Second Life) or face-to-face, both delivered by a single intervention team. Blinded assessors conducted in-person clinical (HbA1c), behavioral, and psychosocial measurements at baseline and 4-month follow-up. Pre-post differences within and between intervention groups were assessed using t tests and chi-square tests (two-sided and intention-to-treat analyses for all comparisons). RESULTS: Participants (N = 89) were an average of 52 years old (SD 10), 60% had \u3c /=high school, 82% had household incomes \u3c US $30,000, and computer experience was variable. Overall session attendance was similar across the groups (6.8/8 sessions, P = .90). Compared to face-to-face, virtual world was slightly superior for total activity, light activity, and inactivity (P = .05, P = .07, and P = .025, respectively). HbA1c reduction was significant within face-to-face (-0.46, P = 02) but not within virtual world (-0.31, P = .19), although there were no significant between group differences in HbA1c (P = .52). In both groups, 14$1117 versus US $931 for face-to-face. CONCLUSIONS: It is feasible to deliver diabetes self-management interventions to inner city African American women via virtual worlds, and outcomes may be comparable to those of face-to-face interventions. Further effectiveness research is warranted. TRIAL REGISTRATION: ClinicalTrials.gov NCT01340079; http://clinicaltrials.gov/show/NCT01340079 (Archived by WebCite at http://www.webcitation.org/6T2aSvmka)