Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000730808
Ethics application status
Approved
Date submitted
6/07/2012
Date registered
9/07/2012
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised controlled trial of an internet delivered physical activity intervention for individuals with Type 2 diabetes
Scientific title
The effectiveness of an internet delivered theory based physical activity intervention titled “Diabetes In Check” to increase physical activity levels in comparison to a control group in a sample of individuals diagnosed with Type 2 Diabetes.
Secondary ID [1] 280790 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 286848 0
Effectiveness of internet delivered physical activity interventions 286849 0
Condition category
Condition code
Public Health 287167 287167 0 0
Health promotion/education
Metabolic and Endocrine 287168 287168 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will be enrolled in a 12-week online physical activity intervention. The interventions website is developed based on a theoretical framework (Theory of planned behaviour) and self-management principles. Participants are asked to regularly visit the intervention website over the 12 week period, however the number of times they access the website and the amount of time they spend on the website is left entirely to their own discretion. During this 12 weeks through the website participants will be able to access weekly education modules, view a library of resources, be able to self-monitor behaviours (view graphs and progress) and participate in discussion forums. In relation to self-monitoring behaviour's participants and will be asked to record self-care behaviours such as physical activity, blood glucose and blood pressure daily and weight weekly. Additionally, participants can set weekly physical activity goals for which they will receive feedback based on their physical activity progress. However, although participants are encouraged through weekly email reminder to make use of all areas of the website, the areas accessed and the utilisation of these tools is left up to the participants discretion.
Intervention code [1] 285217 0
Lifestyle
Intervention code [2] 285218 0
Behaviour
Comparator / control treatment
Control group - the control group also have access to the website but can only access a static web page and links to external diabetes websites. The control group participants are not provided any encouragement to continue to visit the website over the 12 week period. So the the number of times they access the website and the amount of time they spend on the website is left entirely to their own discretion.
Control group
Active

Outcomes
Primary outcome [1] 287468 0
Self-reported physical activity behaviour was the primary outcome measure and was measured using the long form International Physical Activity Questionnaire (IPAQ). The IPAQ has been shown to be a valid and reliable instrument to measure physical activity among adults at a population level (Craig, et al., 2003) and has previously shown to be sensitive enough to detect behaviour change in intervention research (Spittaels, De Bourdeaudhuij, Brug, et al., 2007; Spittaels, De Bourdeaudhuij, & Vandelanotte, 2007). The IPAQ assess the frequency (days) and duration (minutes) of physical activity across five main domains: occupational, transportation, household, leisure time and sitting time. The frequency and duration of time spent in physical activity can be calculated to produce domain specific scores for walking, moderate and vigorous intensity activity.
Timepoint [1] 287468 0
Baseline, 12-weeks and 36-weeks (6 months post intervention)
Secondary outcome [1] 298223 0
Secondary outcomes included a measure of physical activity beliefs according to the TPB, quality of life and satisfaction with the intervention. Physical activity beliefs were measured according to the specifications for the TPB (Ajzen, 1988). This TPB questionnaire has previously proven to be useful in identifying physical activity beliefs in the Type II diabetes population and has shown good internal consistency (Davies, et al., 2010). The first section consisted of four questions each for intention, subjective norm and perceived behavioural control. Each question was measured on a 7-point Likert scale and were randomised throughout. The second section consisted of questions to measure attitudes towards the behaviour using a 12 item semantic differential scale.
Timepoint [1] 298223 0
Baseline, 12-weeks and 6 months post intervention
Secondary outcome [2] 298224 0
Quality of life was measured using the SF-12 which measures the overall physical (PHS) and mental health status (MHS) of individuals (Ware, Kosinski, & Keller, 1996). The SF-12 is a short version of the SF-36 and contains 12 questions that can be answered within a shorter time frame (Burdine, Felix, Abel, Wiltraut, & Musselman, 2000). The SF-12 asks questions across a number of dimensions, including; physical functioning, physical health, emotional health, physical pain, psychological well-being and health perception (Ware, et al., 1996). The sum of these scores provides a physical component and mental health component summary score used as a norm based standardised score (Ware, Kosinski, & Keller, 1998). The SF-12 has previously been used in individuals with Type II diabetes (McKay, et al., 2002) and has been proven to be a valid and reliable measure of quality of life (Ware, et al., 1996).
Timepoint [2] 298224 0
Baseline, 12-weeks and 6 months post intervention
Secondary outcome [3] 298225 0
Program satisfaction was measured for participants in the intervention group to examine overall website satisfaction and usefulness of various program features. The survey has been adapted from the Health-eSteps (Steele, et al., 2007a) and Diabetes NetPLAY (Liebreich, et al., 2009) and was completed at the 12-week post-intervention follow-up. The questionnaire contains 17 items measured using a 5 point Likert scale that ranges from 'strongly agree' to 'strongly disagree' in addition to three open ended questions for participants to record likes/dislikes and recommendations. The questionnaire assesses satisfaction, usability and usefulness of various website components including, online logbooks, goal-setting, education modules, feedback and email reminders.
Timepoint [3] 298225 0
12-weeks - intervention group only
Secondary outcome [4] 298226 0
Website usage as described by the number of times participants logged onto the website. Sections of the website visited and self-monitoring of behaviours were also recorded for website usage.
Timepoint [4] 298226 0
Continuously collected throughout intervention

Eligibility
Key inclusion criteria
Participants were deemed eligible to participate if they met the following criteria; a) diagnosed with Type II diabetes; b) available access to internet and email; c) the ability to read and understand English; d) above 18 years of age; e) meet criteria on physical activity readiness questionnaire (PAR-Q); e) currently not receiving diabetes education and f) not meeting the national physical activity guidelines (national guidelines state that people should accumulate at least 150 minutes moderate physical activity per week). Potential participants who indicated any contraindications as determined by the PAR-Q were required to obtain consent from their general practitioner prior to participating in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Not diagnosed with Type 2 diabetes
b) currently meeting national physical activity guidelines
c) under 18 years of age
d) Indicating contraindications through not meeting the PAR-Q criteria and not providing consent from general practitioner
e) currently participating in another diabetes education program

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Upon initial telephone contact with participants a research assistant will screen participants for initial eligibility criteria. Email addresses and additional contact details will be obtained for all potential participants in the initial phone call. Participants who meet the inclusion criteria will be sent a welcome email containing a link to the website and further information regarding login procedures. Individuals deemed ineligible will be sent a thank-you email with links to other diabetes websites.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants were randomly assigned to intervention or control group based on their call number using simple randomisation by computer generated numbers.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5498 0
4700

Funding & Sponsors
Funding source category [1] 285582 0
University
Name [1] 285582 0
Central Queensland University
Country [1] 285582 0
Australia
Primary sponsor type
University
Name
Central Queensland University
Address
Building 18,
Bruce Highway,
Rockhampton QLD 4701
Country
Australia
Secondary sponsor category [1] 284413 0
None
Name [1] 284413 0
Address [1] 284413 0
Country [1] 284413 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287590 0
Central Queensland University Human Research Ethics Committee
Ethics committee address [1] 287590 0
Building 32,
Bruce Highway,
Rockhampton QLD 4701
Ethics committee country [1] 287590 0
Australia
Date submitted for ethics approval [1] 287590 0
Approval date [1] 287590 0
04/09/2009
Ethics approval number [1] 287590 0
H09/10?061
Ethics committee name [2] 287591 0
Central Queensland Human Research Ethics Committee
Ethics committee address [2] 287591 0
PO Box 871
ROCKHAMPTON QLD 4700
Ethics committee country [2] 287591 0
Australia
Date submitted for ethics approval [2] 287591 0
Approval date [2] 287591 0
13/05/2010
Ethics approval number [2] 287591 0
HREC 10/QCQ/5

Summary
Brief summary
The overall purpose of the final study is to undertake a randomised control trial to test the efficacy of an internet delivered physical activity intervention for individuals with Type II diabetes. The randomised control trial will consist of two groups, an intervention and control group. As previously described the intervention group will receive access to all aspects of the internet intervention, whereas, the control group will only be able to access a static web page containing links to external diabetes websites.
Specifically, the following hypothesis will be tested:

Hypothesis One: It is hypothesised that participants in both groups will report increases in physical activity behaviour, quality of life, physical activity intentions, subjective norms, attitudes and perceived behavioural control at 12 weeks;
a) It is hypothesised that participants in the intervention group will report significantly greater improvements in physical activity behaviour than the control group;
b) It is hypothesised that participants in the intervention group will report significantly greater improvements in their perception of quality of life than the control group;
c) It is hypothesised that participants in the intervention group will report significantly greater improvements in physical activity intentions, subjective norms, attitudes and perceived behavioural control than the control group;
Hypothesis Two: It is hypothesised that individuals in the intervention group will record significantly greater logins in comparison to the control group at the completion of the intervention period.
The combined outcome will provide a better understanding of the effectiveness of internet delivered physical activity behaviour change programs for secondary prevention of chronic diseases. Secondary aims are to explore factors within internet delivered programs which influence website usage in terms of engagement.
Trial website
http://diabetes.incheck.org.au/
Trial related presentations / publications
Davies, C., Vandelanotte, C., Caperchione, C., & Mummery, K. (2011). Randomised controlled trial of an internet delivered physical activity intervention for individuals with type II diabetes. Paper presented at the 2011 Annual Meeting of the International Society for Behavioral Nutrition and Physical Activity (ISBNPA), Melbourne, Australia.
Public notes

Contacts
Principal investigator
Name 34401 0
Address 34401 0
Country 34401 0
Phone 34401 0
Fax 34401 0
Email 34401 0
Contact person for public queries
Name 17648 0
Cally Davies
Address 17648 0
Faculty of Physical Education and Recreation
University of Alberta
Edmonton, Alberta
CANADA
T6G 2H9
Country 17648 0
Canada
Phone 17648 0
+17809015528
Fax 17648 0
Email 17648 0
[email protected]
Contact person for scientific queries
Name 8576 0
Cally Davies
Address 8576 0
Faculty of Physical Education and Recreation
University of Alberta
Edmonton, Alberta
CANADA
T6G 2H9
Country 8576 0
Canada
Phone 8576 0
+17809015528
Fax 8576 0
Email 8576 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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