NCT00877851

Brief Summary

NEW Brief Summary: Managing diet and physical activity are vital aspects of diabetes self-care; however, people with diabetes often find it difficult to make changes to their usual diet and physical activity patterns. There is some evidence that computer based education may help some people develop the skills they need to better manage their diabetes. The investigators have developed an external hard drive (a USB stick), focusing on knowledge, self-monitoring, goal setting and skill-development in relation to diet and physical activity for people with Type 2 diabetes. A major emphasis was placed on eliciting the views of people with Type 2 diabetes throughout the development of the computer based program. This study will examine whether this computer based program can improve knowledge, skills and self-care behaviour in people with diabetes. One hundred participants who have been diagnosed with Type 2 diabetes in the past 2 years will be assigned by chance to one of two groups: they will either be assigned to continue with their normal care routine consulting with their doctor as normal, or they will be assigned to use the USB stick at least once a week for 12 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Apr 2009

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

Study Start

First participant enrolled

April 1, 2009

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
12.5 years until next milestone

Results Posted

Study results publicly available

May 16, 2023

Completed
Last Updated

May 16, 2023

Status Verified

July 1, 2022

Enrollment Period

1.7 years

First QC Date

April 7, 2009

Results QC Date

July 6, 2022

Last Update Submit

July 6, 2022

Conditions

Diabetes Mellitus, Type 2

Keywords

DietPhysical activitySelf managementGoal setting

Outcome Measures

Primary Outcomes (2)

  • Between Group Differences in Diabetes Knowledge

    ADKnowl questionnaire

    12 weeks

  • Between Group Differences in Goal Setting

    12 weeks

Secondary Outcomes (6)

  • Between Group Differences in Dietary Intake

    12 weeks

  • Between Group Differences in Physical Activity Levels

    12 weeks

  • Between Group Difference in Anthropometry

    12 weeks

  • Between Group Differences in Markers of Cardiovascular Risk

    12 weeks

  • Between Group Differences in Markers of Blood Glucose Control

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

1 Computer-based Program

EXPERIMENTAL

Use of Computer-based Program for 12 weeks

Behavioral: Computer-based Program

2 Control

NO INTERVENTION

Usual care and list of useful websites

Interventions

Computer-based ProgramBEHAVIORAL

The intervention group will receive an initial training session which will include a demonstration of the layout and main features of the computer-based program and some instructions on how to navigate around the different sections of the program. As a minimum level of use, participants will be asked to use the self-monitoring and goal setting aspects of the computer-based program on at least a weekly basis.

1 Computer-based Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medical diagnosis of Type 2 diabetes in the past 2 years
  • Have access to a computer on a regular basis

You may not qualify if:

  • Pregnant or lactating
  • Other medical conditions where changes in diet or physical activity would be contraindicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Queen's University Belfast

Belfast, Antrim, BT12 6BJ, United Kingdom

Location

Belfast Health and Social Care Trust

Belfast, Antrim, United Kingdom

Location

Related Publications (1)

  • Booth AO, Lowis C, Hunter SJ, Dean M, Cardwell CR, McKinley MC. Development and Evaluation of a Computer-Based, Self-Management Tool for People Recently Diagnosed with Type 2 Diabetes. J Diabetes Res. 2016;2016:3192673. doi: 10.1155/2016/3192673. Epub 2016 Jun 30.

    PMID: 27446961DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Results Point of Contact

Title
Prof Michelle McKinley
Organization
Queen's University, Belfast
m.mckinley@qub.ac.uk
+44(0)2890632685

Study Officials

  • Michelle McKinley, PhD

    Queen's University, Belfast

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Michelle McKinley

Study Record Dates

First Submitted

April 7, 2009

First Posted

April 8, 2009

Study Start

April 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

May 16, 2023

Results First Posted

May 16, 2023

Record last verified: 2022-07

Locations

GB(2)