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Completed

NCT Number: NCT00877851

Evaluation of a Computer-Based, Self-Management Tool for People With Type 2 Diabetes

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Belfast Health and Social Care Trust, Belfast, Antrim, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Computer-based Program

Behavioral

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.

Primary outcomes

  1. Between Group Differences in Diabetes Knowledge

    Time frame: 12 weeks

    ADKnowl questionnaire

  2. Between Group Differences in Goal Setting

    Time frame: 12 weeks

Secondary outcomes

  1. Between Group Differences in Dietary Intake

    Time frame: 12 weeks

  2. Between Group Differences in Physical Activity Levels

    Time frame: 12 weeks

  3. Between Group Difference in Anthropometry

    Time frame: 12 weeks

  4. Between Group Differences in Markers of Cardiovascular Risk

    Time frame: 12 weeks

  5. Between Group Differences in Markers of Blood Glucose Control

    Time frame: 12 weeks

  6. Between Group Differences in Self-Efficacy and Barriers to Management of Diabetes

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Queen's University, Belfast

Other

Registry information

Official study title

Development and Evaluation of a Computer-Based, Self-Management Tool for People Recently Diagnosed With Type 2 Diabetes (Evaluation Phase)

Acronym: LWD

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 8, 2009
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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