Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000572662
Ethics application status
Approved
Date submitted
29/04/2014
Date registered
29/05/2014
Date last updated
15/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The development of a successful group-based lifestyle modification program for chronic disease, such as type 2 diabetes.
Scientific title
The impact of the "Bond Diabetes Intervention", a group-based patient directed lifestyle modification program for newly diagnosed type 2 diabetes patients, on diabetes knowledge and self-care activities.
Secondary ID [1] 284491 0
Nil
Universal Trial Number (UTN)
U1111-1156-0962
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 291741 0
Condition category
Condition code
Metabolic and Endocrine 292109 292109 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
- Intervention A: Patient directed group education program (discussion based) consists of one 2 hour session weekly for 6 weeks (patient directed with some prompts if patients go completely off topic). Patients will be encouraged to discuss topics relating to their diabetes such as how they feel about their diagnosis, their diet and physical activity, hypoglycaemia, and self care activities. Intervention A will be facilitated by an accredited practising dietitian (APD) (the primary researcher). The focus will be on discussion based activities, goal setting and patient-centered care.
Intervention code [1] 289249 0
Lifestyle
Intervention code [2] 289250 0
Behaviour
Comparator / control treatment
Participants were only recruited to the Bond Diabetes Intervention group. There was no control or comparison group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291993 0
Change in Diabetes Knowledge (measured using the Michigan Diabetes Research and Training Centre diabetes knowledge test)
Timepoint [1] 291993 0
Measures will be taken at baseline (at an initial assessment); following the completion of the intervention (6 weeks post initial assessment) and a follow-up measure will be taken 12 weeks after the initial assessment.
Primary outcome [2] 291994 0
Change in Diabetes Self-Care Activities (using the Summary of Diabetes Self-Care Activities questionnaire)
Timepoint [2] 291994 0
Measures will be taken at baseline (at an initial assessment); following the completion of the intervention (6 weeks post initial assessment) and a follow-up measure will be taken 12 weeks after the initial assessment.
Primary outcome [3] 291995 0
Change in General Nutrition Knowledge (using the General Nutrition Knowledge questionnaire)
Timepoint [3] 291995 0
Measures will be taken at baseline (at an initial assessment); following the completion of the intervention (6 weeks post initial assessment) and a follow-up measure will be taken 12 weeks after the initial assessment.
Secondary outcome [1] 307975 0
Change in Diabetes Self-Efficacy (using the Diabetes Management Self-Efficacy Scale)
Timepoint [1] 307975 0
Measures will be taken at baseline (at an initial assessment); following the completion of the intervention (6 weeks post initial assessment) and a follow-up measure will be taken 12 weeks after the initial assessment.
Secondary outcome [2] 307976 0
Change in Diabetes Related Quality of Life (using the Audit of Diabetes-Dependent Quality of Life questionnaire)
Timepoint [2] 307976 0
Measures will be taken at baseline (at an initial assessment); following the completion of the intervention (6 weeks post initial assessment) and a follow-up measure will be taken 12 weeks after the initial assessment.
Secondary outcome [3] 307977 0
Changes in anthropometric measures (weight, waist circumference, body mass index, and blood pressure)
Timepoint [3] 307977 0
Measures will be taken at baseline (at an initial assessment); following the completion of the intervention (6 weeks post initial assessment) and a follow-up measure will be taken 12 weeks after the initial assessment.

Eligibility
Key inclusion criteria
Participants will be persons over the age of 18 years who have been diagnosed with type 2 diabetes mellitus (T2DM). The participants will need to either be newly diagnosed or not previously educated in a group setting.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they have a reduced cognitive ability, are unable to attend group sessions, or have an insufficient understanding of English.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No allocation concealment was completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No randomised occurred.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Changes over time will be analysed using paired t-tests and Wilcoxon signed rank tests. P<0.05 will be considered to be statistically significant.
The qualitative interviews, which are based upon a series of open ended questions, will be transcribed verbatim by the student researcher. The transcribed text will be read several times and discussed by the research team. Data analysis will be completed manually and independently by all three researchers who will systematically code the data using inductive coding to label the data regardless of previous theory. The data will then be analysed using thematic content analysis and seeking patterning of responses. The analytical themes will be derived on the basis of the analysis. The data obtained from these interviews will be grouped and the similarities and differences between the groups will be assessed. This research is of a descriptive nature, and an interpretive approach will be used in the data analysis.
Sample size calculations (using figures from previous published research) indicate that 22 participants are required to achieve statistical significance. It is assumed that retention of group participants will be below 100%, hence the aim of recruiting 30 participants per group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/05/2014
Actual
12/05/2014
Date of last participant enrolment
Anticipated
Actual
26/08/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 8032 0
4226 - Robina

Funding & Sponsors
Funding source category [1] 289146 0
University
Name [1] 289146 0
Bond University
Country [1] 289146 0
Australia
Primary sponsor type
University
Name
Bond University
Address
2 Promethean Way, Robina, 4226, QLD
Country
Australia
Secondary sponsor category [1] 287810 0
None
Name [1] 287810 0
Address [1] 287810 0
Country [1] 287810 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290919 0
Bond University Research Ethics Committee
Ethics committee address [1] 290919 0
Office of Research Services
Building 1C, Level 4
Bond University QLD 4229
Ethics committee country [1] 290919 0
Australia
Date submitted for ethics approval [1] 290919 0
Approval date [1] 290919 0
16/04/2014
Ethics approval number [1] 290919 0
RO1815

Summary
Brief summary
This intervention study will evaluate a discussion-based, patient directed group education program for the management of newly diagnosed type 2 diabetes. The potential benefits of this research for the researchers and other health professionals in the field, include an improved understanding of how best to educate type 2 diabetes patients in a group setting. Additionally, the impact of group interactions and patient-directed or patient-centred care will be assessed. The potential benefits for the participants include an improved understanding of type 2 diabetes, lifestyle improvements, and improvements in self-management behaviours. Participants will have the opportunity to ask any questions to the health professionals facilitating the groups, and to discuss any issues they have relating to their diabetes with both peers and health professionals.
Trial website
Trial related presentations / publications
No citations to provide.
Public notes

Contacts
Principal investigator
Name 47942 0
Prof Roger Hughes
Address 47942 0
Bond University
Bond Institute for Health and Sport
2 Promethean Way
Robina
4226
QLD
Country 47942 0
Australia
Phone 47942 0
+61755955544
Fax 47942 0
Email 47942 0
[email protected]
Contact person for public queries
Name 47943 0
Miss Kate Odgers-Jewell
Address 47943 0
Bond University
Bond Institute for Health and Sport
2 Promethean Way
Robina
4226
QLD
Country 47943 0
Australia
Phone 47943 0
+61755953037
Fax 47943 0
Email 47943 0
[email protected]
Contact person for scientific queries
Name 47944 0
Miss Kate Odgers-Jewell
Address 47944 0
Bond University
Bond Institute for Health and Sport
2 Promethean Way
Robina
4226
QLD
Country 47944 0
Australia
Phone 47944 0
+61755953037
Fax 47944 0
Email 47944 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.