Back to resultsDiabetes Self-Management & Support LIVE
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LIVE
Website
Sponsored by
About this trial
This is an interventional other trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes, Virtual Environment, Self-Management
Eligibility 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:
-
Sites / Locations
- New York University
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LIVE Arm
Website
Arm Description
Participation in 3D virtual environment for DSMT/S for a period of 12 months.
Participation in 2D website for DSMT/S for a period of 12 months.
Outcomes
Primary Outcome Measures
Change in Dietary Intake
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
Changes in physical activity will be measured using the Fitbit physical activity monitoring at 3, 6, 12, and 18 months.
Secondary Outcome Measures
Change in HbA1C level
Metabolic control (HbA1c) levels will be measured at the start of the study and again at 6, 12, and 18 months
Change in BMI
BMI will measured at the start of study and at 6, 12, and 18 months.
Change in Waist Circumference
Waist circumference will be measured at start of study and at 6, 12, and 18 months.
Change in Blood Pressure
Blood pressure will be measured at the start of the study and again at 6, 12, and 18 months.
Change in Lipid Levels
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.
Full Information
NCT ID
NCT02040038
First Posted
January 16, 2014
Last Updated
April 5, 2018
Sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT02040038
Brief Title
Diabetes Self-Management & Support LIVE
Official Title
Diabetes Self-Management & Support LIVE (Learning in Virtual Environments)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes, Virtual Environment, Self-Management
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
212 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LIVE Arm
Arm Type
Experimental
Arm Description
Participation in 3D virtual environment for DSMT/S for a period of 12 months.
Arm Title
Website
Arm Type
Active Comparator
Arm Description
Participation in 2D website for DSMT/S for a period of 12 months.
Intervention Type
Behavioral
Intervention Name(s)
LIVE
Intervention Description
3-D Virtual Environment for DSMT/S
Intervention Type
Behavioral
Intervention Name(s)
Website
Intervention Description
2-D Website participation for DSMT/S
Primary Outcome Measure Information:
Title
Change in Dietary Intake
Description
Dietary (fat intake, fruit and vegetable intake) will be assessed at start of the study and at 3, 6, 12 and 18 months
Time Frame
18 months
Title
Change in Physical Activity
Description
Changes in physical activity will be measured using the Fitbit physical activity monitoring at 3, 6, 12, and 18 months.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Change in HbA1C level
Description
Metabolic control (HbA1c) levels will be measured at the start of the study and again at 6, 12, and 18 months
Time Frame
18 months
Title
Change in BMI
Description
BMI will measured at the start of study and at 6, 12, and 18 months.
Time Frame
18 months
Title
Change in Waist Circumference
Description
Waist circumference will be measured at start of study and at 6, 12, and 18 months.
Time Frame
18 months
Title
Change in Blood Pressure
Description
Blood pressure will be measured at the start of the study and again at 6, 12, and 18 months.
Time Frame
18 months
Title
Change in Lipid Levels
Description
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.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Constance M. Johnson, PhD
Organizational Affiliation
Duke University School of Nursing
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Allison Vorderstrasse, DNSc
Organizational Affiliation
Duke University School of Nursing
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gail Melkus, EdD
Organizational Affiliation
New York University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28600025
Citation
Johnson CM, McIlwain S, Gray O, Willson B, Vorderstrasse A. Creating a sustainable collaborative consumer health application for chronic disease self-management. J Biomed Inform. 2017 Jul;71:198-206. doi: 10.1016/j.jbi.2017.06.004. Epub 2017 Jun 6.
Results Reference
derived
PubMed Identifier
26505161
Citation
Vorderstrasse AA, Melkus GD, Pan W, Lewinski AA, Johnson CM. Diabetes Learning in Virtual Environments: Testing the Efficacy of Self-Management Training and Support in Virtual Environments (Randomized Controlled Trial Protocol). Nurs Res. 2015 Nov-Dec;64(6):485-93. doi: 10.1097/NNR.0000000000000128.
Results Reference
derived
Learn more about this trial
Diabetes Self-Management & Support LIVE
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