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Trial registered on ANZCTR


Registration number
ACTRN12609000817246
Ethics application status
Approved
Date submitted
16/09/2009
Date registered
18/09/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the go for your Life diabetes prevention program, The Healthy Living Course, in people with pre-diabetes
Scientific title
Do people with pre-diabetes who attend the go for your Life diabetes prevention program, The Healthy Living Course, show a greater improvement in lifestyle, cognitive, metabolic and psychosocial outcomes when compared with people with pre-diabetes who receive standard care?
Secondary ID [1] 1100 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pre-diabetes
Type 2 diabetes mellitus
243851 0
Condition category
Condition code
Metabolic and Endocrine 240027 240027 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The go for your Life diabetes prevention program, The Healthy Living Course, comprises a series of learning sessions conducted in groups of six to ten people with pre-diabetes. The aims of the program are to promote healthy lifestyle change and reduce risk of progression to Type 2 diabetes. Participants undertake one pre-course individual session, in which personal medical history, eating and exercise patterns are discussed and the course explained. Then follow six sessions spread across six months. The sessions are psycho-educational, providing information on diet, exercise, motivation, goal setting and stress, plus support for participants to adopt healthier lifestyle choices.
Intervention code [1] 241293 0
Prevention
Comparator / control treatment
Members of the wait-list control group received standard general practitioner care for pre-diabetes for 6 months while on the waiting list for the intervention.
Control group
Active

Outcomes
Primary outcome [1] 240926 0
Improvement in dietary intake assessed via changes from pretest to post intervention/wait in scores on a questionnaire: The Food Choices Questionnaire (FCQ); items developed from Dietary Guidelines for Australian Adults (National Health and Medical Council (NHMRC), 2003).
Timepoint [1] 240926 0
At baseline and completion of the Healthy Living Course (intervetnion) or waiting period (control group). t=6 months
Primary outcome [2] 240927 0
Increase in physical activity assessed via changes from pretest to post intervention/wait in scores on a questionnaire: adapted form of the International Activity Scale (Craig et al., 2003).
Timepoint [2] 240927 0
At baseline and on completion of the Healthy Living Course (intervetnion) or waiting period (control group). t=6 months
Primary outcome [3] 240928 0
Increase in diabetes knowledge assessed via changes from pretest to post intervention/wait in scores on a questionnaire:the Diabetes Knowledge Scale (13 items developed for current trial)
Timepoint [3] 240928 0
At baseline and on completion of the Healthy Living Course (intervetnion) or waiting period (control group). t=6 months
Primary outcome [4] 240929 0
Reduction in weight assessed via changes from pretest to post intervention/wait in weight in kgm as measured by participants' general practitioners (GPs)
Timepoint [4] 240929 0
At baseline and on completion of the Healthy Living Course (intervetnion) or waiting period (control group). t=6 months
Secondary outcome [1] 257645 0
Changes in metabolic indicators (glucose metabolism, blood pressure triglyceride & cholesterol levels) assessed via changes from pretest to post intervention/wait in blood assays and blood pressure measures as reported by general practitioners (on basis of blood tests).Pre-diabetes was diagnosed via the Oral Glucose Tolerance Test (OGTT); criteria included an absence of diabetes and (a) impaired fasting glucose (IFG) with fasting plasma glucose (FPG) between 6.1 and 7.0 mmol/l, or (b) impaired glucose tolerance (IGT) with 2 hour plasma glucose (2hrPG) between 7.8 and 11.0mmol/l, or (c) both IFG and IGT (World Health Organisation, 1985).
Timepoint [1] 257645 0
At baseline and within 3 months of competing the Healthy Living Course (intervention) or waiting period (control)
Secondary outcome [2] 257646 0
Changes in cognitive variables (motivation and self-efficacy) assessed via changes from pretest to post intervention/wait in scores on questionnaires.
The motivation to change measure was based on Prochaska, DiClemente and Norcross? (1992) trans-theoretical model of behaviour. A one item forced-choice question with five response options assessed whether participants were at the 1) pre-contemplation 2), contemplation 3), preparation 4), action or 5) maintenance stage in relation to maintaining appropriate weight, eating healthy food and engaging in physical exercise.
Self efficacy was assessed using items from the Stanford University Patient Education Research Centre Self efficacy for Diabetes Scale (http://patienteducation.stanford.edu/research/sediabetes.pdf) and the Diabetes Empowerment Scale (Anderson, Funnell, Fitzgerald & Marrero, 2000), adapted for use with a pre-diabetic population.
Timepoint [2] 257646 0
At baseline and on completion of the Healthy Living Course (intervention) or waiting period (control). t= 6 months.
Secondary outcome [3] 257647 0
Changes in mood (depression, anxiety and positive affect) were assessed via changes from pretest to post intervention/wait questionnaires.
The 10-item Positive Affect (PA) sub-scale of the Positive Affect and Negative Affect Scale - PANAS (Watson, Clark & Tellegen, 1988) assessed positive mood.
Depression and anxiety were assessed using the shortened version of the Depression, Anxiety and Stress Scale (DASS-21; Lovibond & Lovibond, 1995)
Timepoint [3] 257647 0
At baseline and on completion of the Healthy Living Course (intervention) or waiting period (control). t= 6 months.

Eligibility
Key inclusion criteria
To be eligible to participate in the study participants had to have pre-diabetes, as diagnosed according to the World Health Organisation (WHO) (1985) criteria for pre-diabetes via an Oral Glucose Tolerance Test (OGTT).
Minimum age
28 Years
Maximum age
86 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants were excluded from the study if they had type 2 diabetes or if they had normal blood sugar metabolism.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Once participants volunteered for the study they were randomly allocated to either the Intervention (N= 208) or the Control group (wait group N= 99) in a ratio of approximately 2:1. Primary health workers from the three recruitment catchment areas were provided with a tear off pad with sheets that were labelled ‘now’ (for intervention) or ‘later’ (for wait-control) in a 2:1 ratio. As each new participant was recruited they were allocated to their group according to the instruction on the next sheet of the tear off pad. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
'Now' and 'Later' were generated in a random sequence in a ratio of 2:1 via throws of a dice - 1, 2, 3 and 4 faces generated 'yes'; 5 and 6 faces generated 'no'.
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2108 0
3128
Recruitment postcode(s) [2] 2109 0
3173
Recruitment postcode(s) [3] 2110 0
3630

Funding & Sponsors
Funding source category [1] 243747 0
Government body
Name [1] 243747 0
Victorian Department of Human Services
Address [1] 243747 0
50 Lonsdale St
Melbourne 3000
Victoria
Country [1] 243747 0
Australia
Primary sponsor type
Individual
Name
Professor Susan Moore
Address
Swinburne University of Technology
Faculty of Life and Social Sciences
PO Box 218
Hawthorn 3122
Victoria
Country
Australia
Secondary sponsor category [1] 237106 0
Government body
Name [1] 237106 0
Victorian Department of Human Services
Address [1] 237106 0
50 Lonsdale St
Melbourne 3000
Victoria
Country [1] 237106 0
Australia
Other collaborator category [1] 872 0
Individual
Name [1] 872 0
Dr Simone Buzwell
Address [1] 872 0
Swinburne University of Technology
Faculty of Life and Social Sciences
PO Box 218
Hawthorn 3122
Victoria
Country [1] 872 0
Australia
Other collaborator category [2] 873 0
Individual
Name [2] 873 0
Dr Naomi Crafti
Address [2] 873 0
Swinburne University of Technology
Faculty of Life and Social Sciences
PO Box 218
Hawthorn 3122
Victoria
Country [2] 873 0
Australia
Other collaborator category [3] 874 0
Individual
Name [3] 874 0
Dr Christine Critchley
Address [3] 874 0
Swinburne University of Technology
Faculty of Life and Social Sciences
PO Box 218
Hawthorn 3122
Victoria
Country [3] 874 0
Australia
Other collaborator category [4] 875 0
Individual
Name [4] 875 0
Dr Elizabeth Hardie
Address [4] 875 0
Swinburne University of Technology
Faculty of Life and Social Sciences
PO Box 218
Hawthorn 3122
Victoria
Country [4] 875 0
Australia
Other collaborator category [5] 876 0
Individual
Name [5] 876 0
Professor Michael Kyrios
Address [5] 876 0
Swinburne University of Technology
Faculty of Life and Social Sciences
PO Box 218
Hawthorn 3122
Victoria
Country [5] 876 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243876 0
Victorian Department of Human Services Human Research Ethics Committee
Ethics committee address [1] 243876 0
DHS Human Research Ethics Committee
Department of Human Services
50 Lonsdale Street
MELBOURNE, Vic; 3000
Ethics committee country [1] 243876 0
Australia
Date submitted for ethics approval [1] 243876 0
Approval date [1] 243876 0
12/04/2006
Ethics approval number [1] 243876 0
10-o6
Ethics committee name [2] 243877 0
Southern Health Human Research Ethics Committee
Ethics committee address [2] 243877 0
Research Support Unit
Research Directorate
Level 4, Main Block,
Monash Medical Centre
246 Clayton Road
CLAYTON VIC 3168
Ethics committee country [2] 243877 0
Australia
Date submitted for ethics approval [2] 243877 0
Approval date [2] 243877 0
09/05/2006
Ethics approval number [2] 243877 0
06021B
Ethics committee name [3] 243878 0
Royal Australian College of General Practitioners' National Research and Evaluation Ethics Committee
Ethics committee address [3] 243878 0
RACGP NREEC Executive Officer
RACGP College House
1 Palmerston Crescent
SOUTH MELBOURNE VIC 3205
Ethics committee country [3] 243878 0
Australia
Date submitted for ethics approval [3] 243878 0
Approval date [3] 243878 0
03/04/2006
Ethics approval number [3] 243878 0
6/01/2009

Summary
Brief summary
The study is a randomised controlled trial (with a wait- list control group) of the six month, group-based go for your Life diabetes prevention program, the Healthy Living Course. Outcome variables included the degree to which participation in the program led to changes in modifiable risk factors including behaviour (physical exercise, dietary intake), diabetes knowledge, body weight, glucose metabolism (measured using an Oral Glucose Tolerance Test (OGTT), triglyceride and cholesterol metabolism, cognitive variables (self efficacy, motivation), and mood (depression, anxiety, and positive affect). Volunteers (N=307) with pre-diabetes were assigned to an intervention or wait control group in the ratio of approximately 2:1. Biochemical, anthropometric, behavioural, cognitive and mood variables were tested at baseline and then again either at the end of the intervention or the wait period.
Trial website
Trial related presentations / publications
Kyrios, M., Moore, S., Hackworth, N., Buzwell, S., Crafti, N., Critchley, C. & Hardie, E. (2009). The influence of depression and anxiety on outcomes following early intervention for pre-diabetes, Medical Journal of Australia, 190 (7), S81-85.
Hackworth, N., Moore, S., Hardie, E.., Buzwell, S., Crafti, N, Critchley, C. & Kyrios, M. (2007). Profile of people with pre-diabetes: behavioural, biochemical and psychosocial, factors, e-Journal of Applied Psychology.3 (2), 14-26.
Moore, S., Buzwell, S., Crafti, N., Critchley, C., Hackworth, N., Hardie, E., & Kyrios, M.(2009). Evaluation of the Diabetes Prevention Program, Conference paper presented at Paving the Way: Pathways of Care for Diabetes, Bendigo Vic, September 10-11, 2009.
Hardie, E., Moore, S., Buzwell, S, Crafti, N., Critchley, C., Hackworth, N., & Kyrios, M. (2009). Evaluation of a lifestyle program for people with pre-diabetes. Paper presented at the 11th European Congress of Psychology, Oslo, Noway, 7-10 July 2009.
Crafti, N., Hackworth, N., & Moore, S. (2008). The dietary intake of people with pre-diabetes: a comparison of two self-report measures. International Journal of Psychology: abstracts of the XXIX International Congress of Psychology, Berlin, Germany, 20-25 July 2008, Vol. 43, no. 3-4 (Jun-Aug 2008), p. 89
Hackworth, N., Moore, S., Hardie, E.., Buzwell, S., Crafti, N, Critchley, C. & Kyrios, M. (2007). Biochemical, behavioural and psychosocial profile of people with pre-diabetes 42nd Annual Conference of the Australian Psychological Society, Brisbane.
Public notes

Contacts
Principal investigator
Name 30292 0
Address 30292 0
Country 30292 0
Phone 30292 0
Fax 30292 0
Email 30292 0
Contact person for public queries
Name 13539 0
Professor Susan Moore
Address 13539 0
Faculty of Life & Social Sciences
Swinburne University of Tehcnology
PO Box 218
Hawthorn, VIC, 3122
Country 13539 0
Australia
Phone 13539 0
+61 3 9214 5694
Fax 13539 0
Email 13539 0
smoore@swin.edu.au
Contact person for scientific queries
Name 4467 0
Professor Susan Moore
Address 4467 0
Faculty of Life & Social Sciences
Swinburne University of Tehcnology
PO Box 218
Hawthorn, VIC, 3122
Country 4467 0
Australia
Phone 4467 0
+61 3 9214 5694
Fax 4467 0
Email 4467 0
smoore@swin.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary