Diabetes Mellitus, Type 2
Conditions
Keywords
Diet, Physical activity, Self management, Goal setting
Brief summary
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.
Interventions
BEHAVIORALComputer-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.
Sponsors
Queen's University, Belfast
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Between Group Differences in Diabetes Knowledge | 12 weeks | ADKnowl questionnaire |
| Between Group Differences in Goal Setting | 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Between Group Difference in Anthropometry | 12 weeks |
| Between Group Differences in Markers of Cardiovascular Risk | 12 weeks |
| Between Group Differences in Dietary Intake | 12 weeks |
| Between Group Differences in Self-Efficacy and Barriers to Management of Diabetes | 12 weeks |
| Between Group Differences in Markers of Blood Glucose Control | 12 weeks |
| Between Group Differences in Physical Activity Levels | 12 weeks |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 41 |
| 2 Control Usual care and list of useful websites | 43 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | computer problem | 3 | 0 |
| Overall Study | Lost to Follow-up | 5 | 5 |
| Overall Study | no longer interested in participating | 1 | 0 |
Baseline characteristics
| Characteristic | 1 Computer-based Program | 2 Control | Total |
|---|---|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 9.1 | 60 years STANDARD_DEVIATION 10.7 | 59 years STANDARD_DEVIATION 9.9 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 19 Participants | 16 Participants | 35 Participants |
| Sex: Female, Male Male | 22 Participants | 27 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 41 | 0 / 43 |
| serious Total, serious adverse events | 0 / 41 | 0 / 43 |
Outcome results
Primary
Between Group Differences in Diabetes Knowledge
ADKnowl questionnaire
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 Computer-based Program | Between Group Differences in Diabetes Knowledge | 67 Percent of items correct | Standard Deviation 10.4 |
| 2 Control | Between Group Differences in Diabetes Knowledge | 64 Percent of items correct | Standard Deviation 14.2 |
Primary
Between Group Differences in Goal Setting
Time frame: 12 weeks
Secondary
Between Group Difference in Anthropometry
Time frame: 12 weeks
Secondary
Between Group Differences in Dietary Intake
Time frame: 12 weeks
Secondary
Between Group Differences in Markers of Blood Glucose Control
Time frame: 12 weeks
Secondary
Between Group Differences in Markers of Cardiovascular Risk
Time frame: 12 weeks
Secondary
Between Group Differences in Physical Activity Levels
Time frame: 12 weeks
Secondary
Between Group Differences in Self-Efficacy and Barriers to Management of Diabetes
Time frame: 12 weeks