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Diabetes Self-Management & Support LIVE

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02040038
Recruitment Status : Completed
First Posted : January 20, 2014
Last Update Posted : April 6, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Duke University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: LIVE Behavioral: Website Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Arms and Interventions
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Arm Intervention/treatment
Experimental: LIVE Arm
Participation in 3D virtual environment for DSMT/S for a period of 12 months.
 Behavioral: LIVE
3-D Virtual Environment for DSMT/S
Active Comparator: Website
Participation in 2D website for DSMT/S for a period of 12 months.
 Behavioral: Website
2-D Website participation for DSMT/S


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. Change in BMI [ Time Frame: 18 months ]
    BMI will measured at the start of study and at 6, 12, and 18 months.

  3. Change in Waist Circumference [ Time Frame: 18 months ]
    Waist circumference will be measured at start of study and at 6, 12, and 18 months.

  4. 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.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 broad band 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 (e.g.
  • Are able to travel to a clinical lab for blood work

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02040038    
Other Study ID Numbers: Pro00043325
1R01HL118189-01 ( U.S. NIH Grant/Contract )
First Posted: January 20, 2014    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: July 2017
Keywords provided by Duke University:
Diabetes
Virtual Environment
Self-Management
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases