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Evaluation of an Interactive CD-ROM for People With Type 2 Diabetes (LWD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00877851
Recruitment Status : Completed
First Posted : April 8, 2009
Last Update Posted : August 22, 2011
Information provided by (Responsible Party):
Michelle McKinley, Queen's University, Belfast

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 interactive CD−ROM, 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 CD−ROM. This study will examine whether this CD−ROM 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 CD−ROM at least once a week for 12 weeks.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: CD-ROM Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Development and Evaluation of an Interactive CD-ROM for People With Type 2 Diabetes (Evaluation Phase)
Study Start Date : April 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 CD-ROM
Use of CD-ROM for 12 weeks
Behavioral: CD-ROM
The intervention group will receive an initial training session which will include a demonstration of the layout and main features of the CD−ROM and some instructions on how to navigate around the different sections of the CD−ROM. As a minimum level of use, participants will be asked to use the self−monitoring and goal setting aspects of the CD−ROM on at least a weekly basis.

No Intervention: 2 Control
Usual care and list of useful websites

Primary Outcome Measures :
  1. Between group differences in diabetes knowledge and goal setting [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00877851

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United Kingdom
Queen's University Belfast
Belfast, Antrim, United Kingdom, BT12 6BJ
Belfast Health and Social Care Trust
Belfast, Antrim, United Kingdom
Sponsors and Collaborators
Queen's University, Belfast
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Principal Investigator: Michelle McKinley, PhD Queen's University, Belfast
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Michelle McKinley, Dr Michelle McKinley, Queen's University, Belfast Identifier: NCT00877851    
Other Study ID Numbers: 08/NIR01/97
First Posted: April 8, 2009    Key Record Dates
Last Update Posted: August 22, 2011
Last Verified: August 2011
Keywords provided by Michelle McKinley, Queen's University, Belfast:
Physical activity
Self management
Goal setting
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases