NCT02040038.

Trial name or title	Diabetes self‐management & support LIVE
Methods	Type of study: efficacy study Allocation: randomised Intervention model: parallel assignment Masking: open label Primary purpose: treatment
Participants	Condition: type 2 diabetes, emotional distress, stress Enrollment: 300 Inclusion criteria: Live in close proximity to Duke University Medical Center (DUMC) or NYU Endocrinology Clinic, or Faculty Practice and Bellevue Medical Center to facilitate follow‐up research appointments Diagnosis of type 2 diabetes (T2D) ≥ 21 years old Able to read and understand English Access to a computer with broadband Internet connection in a private location Reachable by telephone No pre‐existing medical condition(s) or severe diabetes‐related complications that would interfere with study participation Are able to travel to a clinical lab for blood work Exclusion criteria: —
Interventions	Intervention(s): participation in 3D virtual environment for DSMT/S for a period of 12 months. The intervention group have access to the LIVE site where they can find information, synchronous classes with diabetes educators, and peer support to enhance self‐management. Comparator(s): participation in 2D website for DSMT/S for a period of 12 months. The control group have access to the same informational and educational content in a traditional asynchronous Web format.
Outcomes	Timepoint(s): baseline and at 3, 6, 12 and 18 months (for primary outcomes) and at baseline and 6, 12 and 18 months for secondary outcomes Primary outcome(s): Dietary intake (fat intake, fruit and vegetable intake) Physical activity, using the Fitbit physical activity monitoring Secondary outcome(s): HbA1C level BMI Waist circumference Blood pressure Lipid levels (HDL, LDL, total cholesterol and triglyceride levels) Potential mediating effects of changes in self‐efficacy; and diabetes knowledge, diabetes‐related distress, and social support on behaviour change and metabolic outcomes Other outcome(s): —
Starting date	Trial start date: July 2014 Trial completion date: January 2018
Contact information	Responsible party/principal investigator: Duke University/Constance M Johnson, Allison Vorderstrasse and Gail Melkus
Study identifier	NCT number: NCT02040038
Official title	Diabetes self‐management & support LIVE (learning in virtual environments)
Stated purpose of study	Quote: "The purpose of this study is to determine whether participation in virtual environment which incorporates real‐time diabetes self management and support (DSMT/S) is associated with positive changes in behavior and metabolic outcomes as compared to traditional web‐based DSMT/S."
Notes	This study is currently recruiting participants