Trial Review

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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
Scientific title
Evaluating the effect of integrated health mobile text messaging people with Type 2 Diabetes Mellitus for 12 months
Secondary ID [1] 312357 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes mellitus 334137 0
Condition category
Condition code
Metabolic and Endocrine 330812 330812 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 328854 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 338573 0
Change in glycaemic control after intervention group receive their integrated health mobile text messages for 12 months.
Timepoint [1] 338573 0
baseline, and at 6(primary endpoint) and 12 months post-commencement of intervention.
Secondary outcome [1] 436488 0
Change in lipid profile
Timepoint [1] 436488 0
baseline, and at 6 and 12 months post-commencement of intervention
Secondary outcome [2] 438862 0
Change in blood pressure
Timepoint [2] 438862 0
baseline, and at 6 and 12 months post-commencement of intervention.
Secondary outcome [3] 438863 0
Change in weight status
Timepoint [3] 438863 0
baseline, and at 6 and 12 months post-commencement of intervention.
Secondary outcome [4] 438864 0
qualitative evaluation of the following aspects:
- understanding of the text messages
- overall satisfaction with text messages
- acceptability of intervention
- quality of life
- health conditions
Timepoint [4] 438864 0
at 12 months post commencement of intervention

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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation is not concealed
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)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/10/2024
Actual
Date of last participant enrolment
Anticipated
6/02/2025
Actual
Date of last data collection
Anticipated
14/03/2026
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC

Funding & Sponsors
Funding source category [1] 316764 0
Self funded/Unfunded
Name [1] 316764 0
Li Li Dai Emmanuel Nutricare Plus (trading name)
Country [1] 316764 0
Australia
Primary sponsor type
Other
Name
Emmanuel Nutricare Plus
Address
Country
Australia
Secondary sponsor category [1] 318978 0
None
Name [1] 318978 0
Address [1] 318978 0
Country [1] 318978 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315532 0
Oceania University of Medicine
Ethics committee address [1] 315532 0
[email protected]
Ethics committee country [1] 315532 0
Australia
Date submitted for ethics approval [1] 315532 0
19/04/2023
Approval date [1] 315532 0
23/05/2024
Ethics approval number [1] 315532 0
OUMHREC23_008

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134990 0
Mrs Li Li Dai
Address 134990 0
Pendle Hill Family Medical Centre 129-131 Pendle Way, Pendle Hill New South Wales 2145, Australia
Country 134990 0
Australia
Phone 134990 0
+61 401315218
Fax 134990 0
Email 134990 0
[email protected]
Contact person for public queries
Name 134991 0
Li Li Dai
Address 134991 0
Pendle Hill Family Medical Centre 129-131 Pendle Way, Pendle Hill New South Wales 2145, Australia
Country 134991 0
Australia
Phone 134991 0
+61 401315218
Fax 134991 0
Email 134991 0
[email protected]
Contact person for scientific queries
Name 134992 0
Li Li Dai
Address 134992 0
Pendle Hill Family Medical Centre 129-131 Pendle Way, Pendle Hill New South Wales 2145, Australia
Country 134992 0
Australia
Phone 134992 0
+61 401315218
Fax 134992 0
Email 134992 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24069Ethical approval    387983-(Uploaded-18-06-2024-14-43-20)-HREC23_008 Li Li Dai_Approval Letter.pdf
24070Other    letter of support 387983-(Uploaded-18-06-2024-14-45-48)-LetterofSupport_Lili Dai.pdf
24071Study protocol    387983-(Uploaded-18-06-2024-14-46-25)-Research prospectus.pdf
24072Other    letter of support 387983-(Uploaded-08-07-2024-12-49-59)-consent letter main street.pdf
24073Other    letter of support 387983-(Uploaded-08-07-2024-12-51-11)-Granville research consent letter.pdf
24074Other    letter of support 387983-(Uploaded-08-07-2024-12-54-41)-Li Li Consent Letter from Pendle Hill.pdf
24075Informed consent form    387983-(Uploaded-08-07-2024-13-17-07)-participants consent form.pdf
24076Other    letter of support 387983-(Uploaded-01-08-2024-16-59-02)-Main st letter to Louisa.pdf
24077Other    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
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