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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Computer-based Program | Experimental | Use of Computer-based Program for 12 weeks |
|
| 2 Control | No Intervention | Usual care and list of useful websites |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Between Group Differences in Diabetes Knowledge | ADKnowl questionnaire | 12 weeks |
| Between Group Differences in Goal Setting | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Between Group Differences in Dietary Intake | 12 weeks | |
| Between Group Differences in Physical Activity Levels | 12 weeks | |
| Between Group Difference in Anthropometry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle McKinley, PhD | Queen's University, Belfast | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen's University Belfast | Belfast | Antrim | BT12 6BJ | United Kingdom | ||
| Belfast Health and Social Care Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27446961 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 Computer-based Program | Use of Computer-based Program for 12 weeks Computer-based Program: 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. |
| FG001 | 2 Control | Usual care and list of useful websites |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 Computer-based Program | Use of Computer-based Program for 12 weeks Computer-based Program: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Between Group Differences in Diabetes Knowledge | ADKnowl questionnaire | Posted | Mean | Standard Deviation | Percent of items correct | 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1 Computer-based Program | Use of Computer-based Program for 12 weeks Computer-based Program: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Michelle McKinley | Queen's University, Belfast | +44(0)2890632685 | m.mckinley@qub.ac.uk |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| 12 weeks |
| Between Group Differences in Markers of Cardiovascular Risk | 12 weeks |
| Between Group Differences in Markers of Blood Glucose Control | 12 weeks |
| Between Group Differences in Self-Efficacy and Barriers to Management of Diabetes | 12 weeks |
| Belfast |
| Antrim |
| United Kingdom |
| no longer interested in participating |
|
| BG001 | 2 Control | Usual care and list of useful websites |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Primary | Between Group Differences in Goal Setting | Not Posted | 12 weeks | Participants |
| Secondary | Between Group Differences in Dietary Intake | Not Posted | 12 weeks | Participants |
| Secondary | Between Group Differences in Physical Activity Levels | Not Posted | 12 weeks | Participants |
| Secondary | Between Group Difference in Anthropometry | Not Posted | 12 weeks | Participants |
| Secondary | Between Group Differences in Markers of Cardiovascular Risk | Not Posted | 12 weeks | Participants |
| Secondary | Between Group Differences in Markers of Blood Glucose Control | Not Posted | 12 weeks | Participants |
| Secondary | Between Group Differences in Self-Efficacy and Barriers to Management of Diabetes | Not Posted | 12 weeks | Participants |
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | 2 Control | Usual care and list of useful websites | 0 | 43 | 0 | 43 |
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| D004700 | Endocrine System Diseases |
| D001519 | Behavior |