Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Monash University Human Research Ethics Committee
Room 111, Chancellery Building E
24 Sports Walk, Clayton Campus
Research Office
Monash University VIC 3800
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
This intervention study will test the effectiveness and explore appropriateness of a Chinese multi-session culturally-tailored diabetes group education program which is designed to carefully match with the Chinese people’s preferred learning style and include Chinese-specific strategies to motivate and sustain healthy behaviour change. The research will involve recruiting 50 Chinese Cantonese-speaking people with type 2 diabetes into this study. Participants will attend a 6-session group education program delivered in Cantonese by a dietitian, physiotherapist, podiatrist and diabetes nurse. The program will then be evaluated on its effectiveness and appropriateness via pre- and post-program anthropometric and biochemical measurements, questionnaires and qualitative participant-observation. This research is expected to provide new practice ideas to enhance diabetes education, especially for the culturally and linguistically diverse populations.
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
[email protected]
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
[email protected]
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
[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.