Evaluation of an Interactive CD-ROM for People With Type 2 Diabetes - Full Text View

Sponsored by:	Queen's University, Belfast
Information provided by:	Queen's University, Belfast
ClinicalTrials.gov Identifier:	NCT00877851

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

MedlinePlus related topics: Diabetes Diets

U.S. FDA Resources

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

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

Primary Outcome Measures:

Between group differences in diabetes knowledge and goal setting [ Time Frame: baseline and week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

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

Arms	Assigned Interventions
1 CD-ROM: Experimental 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.
2 Control: No Intervention Usual care and list of useful websites

Arms

Assigned Interventions

1 CD-ROM: Experimental

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.

2 Control: No Intervention

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

Contacts

Contact: Michelle McKinley, PhD

+44(0)2890632685 ext 2685

m.mckinley@qub.ac.uk

Locations

United Kingdom, Antrim
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:	Queen's University Belfast ( Dr M McKinley )
Study ID Numbers:	08/NIR01/97
Study First Received:	April 7, 2009
Last Updated:	April 7, 2009
ClinicalTrials.gov Identifier:	NCT00877851 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Queen's University, Belfast:

Diet
Physical activity
Self management
Goal setting

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009