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Trial registered on ANZCTR
Registration number
ACTRN12624001052527
Ethics application status
Approved
Date submitted
5/08/2024
Date registered
29/08/2024
Date last updated
29/08/2024
Date data sharing statement initially provided
29/08/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Mobile texting health related messages, including medical, diet, exercise, and psychological support follow-up people with Type 2 diabetes mellitus for 12 months
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Scientific title
Evaluating the effect of integrated health mobile text messaging people with Type 2 Diabetes Mellitus for 12 months
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Secondary ID [1]
312357
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Nil Known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes mellitus
334137
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Condition category
Condition code
Metabolic and Endocrine
330812
330812
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Provide integrated health information via mobile text messaging method to people with type 2 diabetes mellitus for 12 months
- text messages content: strategies for glycaemic control, prevention of developing diabetes complications
- text messages delivers as text
- text messages will be sent 4 times a week for the initial 3 months of the study, then it will reduce to 3 times a week for the next 6 months and will further reduce to twice and once a week for the remaining 3 months
- text messages was prepared and reviewed by endocrinologist, GP, dietitian, diabetes educator, nurse specialing in diabetes, clinial physiotherapist and research staff.
- strategies used to monitor adherence to the interventio: study specific questinnaire asking participants if they read the text messages
example 1
Dear participants, we understand eating out is an important part of your lives and meets your social needs. However, sometimes it can be challenging to remain eat healthy when dining out.
Please check the following link for some healthy eating tips.
https://www.ndss.com.au/wp-content/uploads/fact-sheets/fact-sheet-eating-out.pdf
example 2
Dear participants, for a simple but delicious heatlhy sandwiches:
* choose grainy bread
* add extra salad fillings
* spread the bread with avocado
* choose reduced fat cheese or mayonnaise
* choose lean meats (chicken breast, tuna, salmon, felafel)
https://www.betterhealth.vic.gov.au/health/healthyliving/healthy-cooking-tips
example 3
Dear participant, type 2 diabetes is the most common diabetes where there is too much glucose in the blood. When you eat food that contain carbohydrates e.g. bread, rice, fruit, the glucose or sugar can only enter the body’s cell when the ‘doors’ are opened by enough insulin (a hormone produced by your pancreas). Unfortunately, due to your condition, your insulin’s level has been reduced or not working well, so it takes longer for carbohydrate foods become energy to meet your body’s needs, just like your car needs petrol. So the glucose stays in the blood longer which results in high blood glucose levels.
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Intervention code [1]
328854
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Treatment: Other
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Comparator / control treatment
control group - do not receive any integrated health information via mobile text messaging, they will just receive their usual health intervention from their own health professionals.
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in glycaemic control after intervention group receive their integrated health mobile text messages for 12 months.
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Assessment method [1]
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HbA1c level from blood test
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Timepoint [1]
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baseline, and at 6(primary endpoint) and 12 months post-commencement of intervention.
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Secondary outcome [1]
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Change in lipid profile
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Assessment method [1]
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blood tests - lipid profile
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Timepoint [1]
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baseline, and at 6 and 12 months post-commencement of intervention
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Secondary outcome [2]
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Change in blood pressure
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Assessment method [2]
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blood pressure measurement by using blood pressure monitor
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Timepoint [2]
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baseline, and at 6 and 12 months post-commencement of intervention.
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Secondary outcome [3]
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Change in weight status
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Assessment method [3]
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scale for weight measurement
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Timepoint [3]
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baseline, and at 6 and 12 months post-commencement of intervention.
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Secondary outcome [4]
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qualitative evaluation of the following aspects:
- understanding of the text messages
- overall satisfaction with text messages
- acceptability of intervention
- quality of life
- health conditions
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Assessment method [4]
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evaluation form of post study (specifically designed for this study)
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Timepoint [4]
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at 12 months post commencement of intervention
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Eligibility
Key inclusion criteria
Type 2 diabetes mellitus
diet control or take oral hypoglycaemics (single, dual or triple) at a stable dose, medically stable
age 18-70 years old, a wide range of ethnic backgrounds
fluent in English
have mobile access to SMS text messages
exercise tolerant (nil restriction), note: exercise may need to be ceased when in particular medical conditions/operation
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Type 1 diabetes, type 2 diabetes uses insulin, pre-diabetes, gestational diabetes, other forms of diabetes
multiple comorbidities (Chronic kidney disease, Congestive heart failure & other advanced/severe/unstable Cardiovascular diseases)
receive chemo/radiotherapies, receive palliative care
planning for major surgery or medically unstable
unstable diabetes medication (initial adjustment period after newly diagnosed DM)
Polyphyarmacy of regular medications or drugs interact with some nutrients e.g. warfarin, K sparing, ACEi
exercises restriction (poor exercise tolerance, motor dysfunction, MI 4 weeks before the study, cerebrovascular diseases, severe osteoporosis, other potential conditions, if unsure - will need GP to conduct a pre-exercise assessment)
limited English proficiency (reading & speaking
age <18 or >70 years
planning for pregnancy, pregnancy
special dietary needs e..g gluten-free diet, low FODMAP diet
on any weight loss program
unstable psychological states/mental illness
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation is not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
3/10/2024
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Actual
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Date of last participant enrolment
Anticipated
6/02/2025
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Actual
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Date of last data collection
Anticipated
14/03/2026
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Actual
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Sample size
Target
150
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Li Li Dai Emmanuel Nutricare Plus (trading name)
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
Other
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Name
Emmanuel Nutricare Plus
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
318978
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Country [1]
318978
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Oceania University of Medicine
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Ethics committee address [1]
315532
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cao@oum.edu.ws
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Ethics committee country [1]
315532
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Australia
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Date submitted for ethics approval [1]
315532
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19/04/2023
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Approval date [1]
315532
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23/05/2024
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Ethics approval number [1]
315532
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OUMHREC23_008
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Summary
Brief summary
The purposes of this study is to 1. Determine if integrated health mobile text messages (unidirectional), including medical, diet, exercises, and psychological support follow-up people with Type 2 diabetes for 12 months, can improve their glycaemic control at 6 and 12 months. 2. Determine if participants’ lipid profiles, blood pressure, and weight status (BMI) can also be improved at 6 and 12 months We hypothesize that there will be improved HbA1c, lipid profiles, blood pressure, and weight status (BMI) in 6 months and a further improvement in 12 months; there will be a high acceptance rate or high satisfaction levels about this research from participants.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mrs Li Li Dai
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Address
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Pendle Hill Family Medical Centre 129-131 Pendle Way, Pendle Hill New South Wales 2145, Australia
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Country
134990
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Australia
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Phone
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+61 401315218
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Fax
134990
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Email
134990
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[email protected]
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Contact person for public queries
Name
134991
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Li Li Dai
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Address
134991
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Pendle Hill Family Medical Centre 129-131 Pendle Way, Pendle Hill New South Wales 2145, Australia
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Country
134991
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Australia
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Phone
134991
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+61 401315218
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Fax
134991
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Email
134991
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[email protected]
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Contact person for scientific queries
Name
134992
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Li Li Dai
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Address
134992
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Pendle Hill Family Medical Centre 129-131 Pendle Way, Pendle Hill New South Wales 2145, Australia
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Country
134992
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Australia
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Phone
134992
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+61 401315218
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Fax
134992
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Email
134992
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
24069
Ethical approval
387983-(Uploaded-18-06-2024-14-43-20)-HREC23_008 Li Li Dai_Approval Letter.pdf
24070
Other
letter of support
387983-(Uploaded-18-06-2024-14-45-48)-LetterofSupport_Lili Dai.pdf
24071
Study protocol
387983-(Uploaded-18-06-2024-14-46-25)-Research prospectus.pdf
24072
Other
letter of support
387983-(Uploaded-08-07-2024-12-49-59)-consent letter main street.pdf
24073
Other
letter of support
387983-(Uploaded-08-07-2024-12-51-11)-Granville research consent letter.pdf
24074
Other
letter of support
387983-(Uploaded-08-07-2024-12-54-41)-Li Li Consent Letter from Pendle Hill.pdf
24075
Informed consent form
387983-(Uploaded-08-07-2024-13-17-07)-participants consent form.pdf
24076
Other
letter of support
387983-(Uploaded-01-08-2024-16-59-02)-Main st letter to Louisa.pdf
24077
Other
letter of support
387983-(Uploaded-05-08-2024-17-57-43)-Signed consent letter.RMC Melbourne.pdf
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.
Download to PDF