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Trial registered on ANZCTR


Registration number
ACTRN12617000408381
Ethics application status
Approved
Date submitted
16/03/2017
Date registered
21/03/2017
Date last updated
10/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of a Chinese diabetes education workshop named ‘Not Scared of Sugar’ among Cantonese-speaking Australians with type 2 diabetes
Scientific title
Evaluating the effect of a multi-session multidisciplinary Chinese diabetes education workshop named 'Not Scared of Sugar' on anthropometric measurements, self-care habits, and glycemic & lipid control among Cantonese-speaking Australians with type 2 diabetes: A pilot intervention study
Secondary ID [1] 291441 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 302477 0
Condition category
Condition code
Metabolic and Endocrine 302038 302038 0 0
Diabetes
Public Health 302073 302073 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants (Cantonese-speaking Australians with type 2 diabetes) will be provided with a 6-session diabetes group-education (5x fortnightly 2hour session plus a 2hour follow-up session at 6-month from session 1 = over 6 months for the whole program) delivered by a multidisciplinary diabetes team (dietitian, diabetes nurse educator, physiotherapist and podiatrist). The six sessions will be delivered in Cantonese and culturally-tailored to the Chinese people's preferred learning style based on evidence. The group-education consists of diabetes self-management information provision and participation in activities like resistance training led by the physiotherapist (using appropriate theraband individually-determined by the physiotherapist with a simple risk assessment and optional opting out). A lesson plan (see below) has been developed collectively by the health professional team with consumer consultation, to ensure consistency and enhance cultural appropriateness. To encourage attendance of all sessions, patient-participants will be presented with a certificate of participation upon completion (at session 6).

To measure the effectiveness of the group diabetes education program, the following will be collected at session 1 (baseline), session 5 (8 week post-baseline) and session 6 (24-26 week post-baseline), and at 12 month follow-up: (1) height, weight, waist and blood pressure; (2) questionnaires regarding lifestyle habits, diabetes self-management behaviours, diabetes-related psychological distress, satisfaction with the education program; (3) blood test results (provided by participants' General Practitioner) for HbA1c and lipid profile.

Lesson plan (aligning with the AADE7 self-care behaviours):
Session 1: Pathophysiology of diabetes, annual cycle of care (facilitator who is the dietitian)
Session 2: Self-blood glucose monitoring & medications (diabetes nurse educator) and dietary management (dietitian)
Session 3: Dietary management (dietitian)
Session 4: Physical activity management & exercise (physiotherapist)
Session 5: Foot care (podiatrist) and diabetes related distress management (facilitator who is the dietitian)
Follow-up session: Progress discussion & management of relapse (facilitator who is the dietitian)
Intervention code [1] 297490 0
Lifestyle
Intervention code [2] 297543 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301464 0
Change in self-care behaviours (collected using the AADE7 questionnaire borrowed from the DAWN2 study - not validated)
Timepoint [1] 301464 0
At session 1 (baseline), session 6 (24-26-weeks from baseline) and at 12-month follow-up (52 weeks from baseline)
Primary outcome [2] 301465 0
Glycated haemoglobin (HbA1c) - requested from GPs
Timepoint [2] 301465 0
At session 1 (baseline), session 6 (24-26 weeks from baseline)
Primary outcome [3] 301466 0
Lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides) - requested from GPs
Timepoint [3] 301466 0
At session 1 (baseline), session 6 (24-26 weeks from baseline)
Secondary outcome [1] 332737 0
Body mass index (BMI) - this is a primary outcome
Timepoint [1] 332737 0
At session 1 (baseline), session 5 (8 weeks from baseline) and at session 6 (24-26 weeks from baseline)
Secondary outcome [2] 332738 0
Waist circumference - this is a primary outcome
Timepoint [2] 332738 0
At session 1 (baseline), session 5 (8 weeks from baseline) and at session 6 (24-26 weeks from baseline)
Secondary outcome [3] 332739 0
Blood pressure - this is a primary outcome
Timepoint [3] 332739 0
At session 1 (baseline), session 5 (8 weeks from baseline) and at session 6 (24-26 weeks from baseline)
Secondary outcome [4] 332740 0
Dietary variety (collected using the translated Food Variety Checklist developed by Nutrition Australia - not validated)
Timepoint [4] 332740 0
At session 1 (baseline), session 6 (24-26 weeks from baseline)
Secondary outcome [5] 332867 0
Emotional feelings related to diabetes (collected using Problem Areas in Diabetes questionnaire)
Timepoint [5] 332867 0
At session 1 (baseline), session 5 (8 weeks from baseline) and at session 6 (24-26 weeks from baseline)
Secondary outcome [6] 332868 0
Perceived wellbeing (measured by EQ-5D questionnaire)
Timepoint [6] 332868 0
At session 1 (baseline), session 5 (8 weeks from baseline), at session 6 (24-26 weeks from baseline), and at 12-month follow-up (52 weeks from baseline)
Secondary outcome [7] 332869 0
Patient satisfaction of diabetes education program (collected using the translated Patient Evaluation of Quality of Care questionnaire - validated)
Timepoint [7] 332869 0
At session 6 (24-26 weeks from baseline)
Secondary outcome [8] 332870 0
qualitative participant-observation data (collected by researcher documenting anonymous observation field-notes, capturing the behaviours of participants during the program, e.g. participants dozing off during discussion of foot care)
Timepoint [8] 332870 0
At the end of each session

Eligibility
Key inclusion criteria
- Cantonese-speaking Australians with type 2 diabetes
- lives in Melbourne
- 18 and above years of age
- has a General Practitioner (GP) in Melbourne
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- does not have type 2 diabetes
- does not speak Cantonese
- currently pregnant
- mentally unstable to attend group education with other patients
- unable to commit to the entire 6-session program
- do not have a General Practitioner (GP) in Melbourne

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)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Pre-post intervention study design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a pilot study - no statistical calculation was done to determine sample size. The sample of 50 was decided based on practicality constraints with the funding.

Data will be assessed for normality using the Shapiro-Wilk test. Significant (P<0.05) changes in pre- versus post intervention outcomes will be determined using paired t-tests (2 time-points) and repeated-measures ANOVA (>2 time points), or their non-parametric equivalent.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
Other reasons
Time constraint
Date of first participant enrolment
Anticipated
Actual
12/03/2017
Date of last participant enrolment
Anticipated
Actual
8/09/2017
Date of last data collection
Anticipated
5/10/2018
Actual
Sample size
Target
50
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 15590 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 295908 0
Charities/Societies/Foundations
Name [1] 295908 0
Australian Diabetes Educators Association Diabetes Research Foundation
Country [1] 295908 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Level 1, 264 Ferntree Gully Road,
Notting Hill VIC 3168
Country
Australia
Secondary sponsor category [1] 294782 0
Other
Name [1] 294782 0
Carrington Health
Address [1] 294782 0
Level 2, 43 Carrington Road
Box Hill, VIC 3128
Country [1] 294782 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297189 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 297189 0
Ethics committee country [1] 297189 0
Australia
Date submitted for ethics approval [1] 297189 0
21/02/2017
Approval date [1] 297189 0
10/03/2017
Ethics approval number [1] 297189 0
2017-7872

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1581 1581 0 0
/AnzctrAttachments/372555-2017-7872 Certificate of Approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 73278 0
Dr Tammie ST Choi
Address 73278 0
Monash University
Department of Nutrition, Dietetics and Food
Level 1, 264 Ferntree Gully Road,
Notting Hill, VIC 3168.
Country 73278 0
Australia
Phone 73278 0
+61468302415
Fax 73278 0
Email 73278 0
tammie.choi@monash.edu
Contact person for public queries
Name 73279 0
Tammie ST Choi
Address 73279 0
Monash University
Department of Nutrition, Dietetics and Food
Level 1, 264 Ferntree Gully Road,
Notting Hill, VIC 3168.
Country 73279 0
Australia
Phone 73279 0
+61468302415
Fax 73279 0
Email 73279 0
tammie.choi@monash.edu
Contact person for scientific queries
Name 73280 0
Tammie ST Choi
Address 73280 0
Monash University
Department of Nutrition, Dietetics and Food
Level 1, 264 Ferntree Gully Road,
Notting Hill, VIC 3168.
Country 73280 0
Australia
Phone 73280 0
+61468302415
Fax 73280 0
Email 73280 0
tammie.choi@monash.edu

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.