Clinical trial NCT00877851: Evaluation of a Computer-Based, Self-Management Tool for People With Type 2 Diabetes
Official title: Development and Evaluation of a Computer-Based, Self-Management Tool for People Recently Diagnosed With Type 2 Diabetes (Evaluation Phase)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diet
Physical activity
Self management
Goal setting
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
First posted: 2009-04-08
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Between Group Differences in Diabetes Knowledge
timeFrame: 12 weeks
measure: Between Group Differences in Goal Setting
timeFrame: 12 weeks
Secondary outcomes:
measure: Between Group Differences in Dietary Intake
timeFrame: 12 weeks
measure: Between Group Differences in Physical Activity Levels
timeFrame: 12 weeks
measure: Between Group Difference in Anthropometry
timeFrame: 12 weeks
measure: Between Group Differences in Markers of Cardiovascular Risk
timeFrame: 12 weeks
measure: Between Group Differences in Markers of Blood Glucose Control
timeFrame: 12 weeks
measure: Between Group Differences in Self-Efficacy and Barriers to Management of Diabetes
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Queen's University Belfast
state: Antrim
city: Belfast
country: United Kingdom
facility: Belfast Health and Social Care Trust
state: Antrim
Study officials:
affiliation: Queen's University, Belfast
name: Michelle McKinley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.