Diabetes Self-Management & Support LIVE
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|ClinicalTrials.gov Identifier: NCT02040038|
Recruitment Status : Completed
First Posted : January 20, 2014
Last Update Posted : April 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Behavioral: LIVE Behavioral: Website||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||212 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diabetes Self-Management & Support LIVE (Learning in Virtual Environments)|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||March 2018|
|Actual Study Completion Date :||March 2018|
Experimental: LIVE Arm
Participation in 3D virtual environment for DSMT/S for a period of 12 months.
3-D Virtual Environment for DSMT/S
Active Comparator: Website
Participation in 2D website for DSMT/S for a period of 12 months.
2-D Website participation for DSMT/S
- Change in Dietary Intake [ Time Frame: 18 months ]Dietary (fat intake, fruit and vegetable intake) will be assessed at start of the study and at 3, 6, 12 and 18 months
- Change in Physical Activity [ Time Frame: 18 months ]Changes in physical activity will be measured using the Fitbit physical activity monitoring at 3, 6, 12, and 18 months.
- Change in HbA1C level [ Time Frame: 18 months ]Metabolic control (HbA1c) levels will be measured at the start of the study and again at 6, 12, and 18 months
- Change in BMI [ Time Frame: 18 months ]BMI will measured at the start of study and at 6, 12, and 18 months.
- Change in Waist Circumference [ Time Frame: 18 months ]Waist circumference will be measured at start of study and at 6, 12, and 18 months.
- Change in Blood Pressure [ Time Frame: 18 months ]Blood pressure will be measured at the start of the study and again at 6, 12, and 18 months.
- Change in Lipid Levels [ Time Frame: 18 months ]High density lipoprotein (HDL), low density lipoprotein (LDL), total cholesterol (TC) and triglyceride levels will be measured at the start of the study and again at 6, 12 and 18 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02040038
|United States, New York|
|New York University|
|New York, New York, United States, 10003|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Constance M. Johnson, PhD||Duke University School of Nursing|
|Principal Investigator:||Allison Vorderstrasse, DNSc||Duke University School of Nursing|
|Principal Investigator:||Gail Melkus, EdD||New York University|