NCT02040038

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

April 6, 2018

Status Verified

July 1, 2017

Enrollment Period

3.7 years

First QC Date

January 16, 2014

Last Update Submit

April 5, 2018

Conditions

Diabetes Mellitus, Type 2

Keywords

DiabetesVirtual EnvironmentSelf-Management

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    18 months

Secondary Outcomes (5)

  • Change in HbA1C level

    18 months

  • Change in BMI

    18 months

  • Change in Waist Circumference

    18 months

  • Change in Blood Pressure

    18 months

  • Change in Lipid Levels

    18 months

Study Arms (2)

LIVE Arm

EXPERIMENTAL

Participation in 3D virtual environment for DSMT/S for a period of 12 months.

Behavioral: LIVE

Website

ACTIVE COMPARATOR

Participation in 2D website for DSMT/S for a period of 12 months.

Behavioral: Website

Interventions

LIVEBEHAVIORAL

3-D Virtual Environment for DSMT/S

LIVE Arm
WebsiteBEHAVIORAL

2-D Website participation for DSMT/S

Website

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

New York University

New York, New York, 10003, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (3)

  • Johnson CM, D'Eramo Melkus G, Reagan L, Pan W, Amarasekara S, Pereira K, Hassell N, Nowlin S, Vorderstrasse A. Learning in a Virtual Environment to Improve Type 2 Diabetes Outcomes: Randomized Controlled Trial. JMIR Form Res. 2023 Apr 20;7:e40359. doi: 10.2196/40359.

    PMID: 36962700DERIVED

  • 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.

    PMID: 28600025DERIVED

  • 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.

    PMID: 26505161DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2014

First Posted

January 20, 2014

Study Start

July 1, 2014

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

April 6, 2018

Record last verified: 2017-07

Locations

US(2)