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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michelle McKinley, Queen's University, Belfast
ClinicalTrials.gov Identifier:
NCT00877851
First received: April 7, 2009
Last updated: August 19, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention
Diabetes Mellitus, Type 2
 Behavioral: CD-ROM

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Development and Evaluation of an Interactive CD-ROM for People With Type 2 Diabetes (Evaluation Phase)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Queen's University, Belfast:

Primary Outcome Measures:
  • Between group differences in diabetes knowledge and goal setting [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Between group differences in dietary intake [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • between group differences in physical activity levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • between group difference in anthropometry [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • between group differences in markers of cardiovascular risk [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Between group differences in markers of blood glucose control [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Between group differences in self−efficacy and barriers to management of diabetes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00877851

Locations
United Kingdom
Belfast Health and Social Care Trust
Belfast, Antrim, United Kingdom
Queen's University Belfast
Belfast, Antrim, United Kingdom, BT12 6BJ
Sponsors and Collaborators
Queen's University, Belfast
Investigators
Principal Investigator: Michelle McKinley, PhD Queen's University, Belfast
  More Information

No publications provided

Responsible Party: Michelle McKinley, Dr Michelle McKinley, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT00877851     History of Changes
Other Study ID Numbers: 08/NIR01/97
Study First Received: April 7, 2009
Last Updated: August 19, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Queen's University, Belfast:
Diet
Physical activity
Self management
Goal setting

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013