Diabetes Self-Management & Support LIVE

April 5, 2018 updated by: Duke University

Diabetes Self-Management & Support LIVE (Learning in Virtual Environments)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

212

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • New York University
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
18 months
Change in BMI
Time Frame: 18 months
BMI will measured at the start of study and at 6, 12, and 18 months.
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.
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.
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.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (ACTUAL)

March 1, 2018

Study Completion (ACTUAL)

March 1, 2018

Study Registration Dates

First Submitted

January 16, 2014

First Submitted That Met QC Criteria

January 16, 2014

First Posted (ESTIMATE)

January 20, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 6, 2018

Last Update Submitted That Met QC Criteria

April 5, 2018

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00043325
  • 1R01HL118189-01 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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