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Trial registered on ANZCTR


Registration number
ACTRN12617000416392
Ethics application status
Approved
Date submitted
7/12/2016
Date registered
23/03/2017
Date last updated
11/03/2019
Date data sharing statement initially provided
11/03/2019
Date results information initially provided
11/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Text message program to improve the health of people with type 2 diabetes.
Scientific title
The effectiveness of a text message intervention on lifestyle risk factor modification and diabetes self-management compared to usual care for people with type 2 diabetes: a randomised controlled trial.
Secondary ID [1] 290551 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 300995 0
Condition category
Condition code
Metabolic and Endocrine 300790 300790 0 0
Diabetes
Public Health 300791 300791 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive mobile phone text messages for 6 months. For Phase 1 (the first 3 months), participants in the intervention group will receive a text message every day at a random time between 8 am and 5 pm. The text messages will provide information, motivation and support on physical activity, nutrition, weight, and diabetes self-management. Participants who smoke tobacco or take medication for diabetes (ie tablets or insulin) will also receive an additional message on smoking and medication adherence each fortnight. For Phase 2 (4th to 6th month) participants will receive the text messages four times per week. Participants who smoke tobacco or take medication for diabetes (ie tablets or insulin) will also receive an additional message on smoking and medication adherence each month. The information in the text messages is based on validated guidelines for people with type 2 diabetes, advice from academic and clinical experts, and the published literature. The delivery of the text messages will be unidirectional. The messaging software will provide a report on the delivery of messages to participants.
Intervention code [1] 296415 0
Behaviour
Intervention code [2] 296416 0
Treatment: Other
Comparator / control treatment
The control group will receive usual care; this will generally include standard advice and treatment from their doctor, diabetes specialists or other health professionals. Participants may also receive resources and services from their local diabetes service; and state and national organisations for people with type 2 diabetes.
Control group
Active

Outcomes
Primary outcome [1] 300207 0
HbA1c as measured by blood test.
Timepoint [1] 300207 0
Baseline, 3 months and 6 months.
Secondary outcome [1] 329351 0
Body mass index will be collected on pathology request forms and via self-report on the questionnaire.
Timepoint [1] 329351 0
Baseline, 3 months and 6 months.
Secondary outcome [2] 329353 0
Physical activity will be measured using the two-question (2Q) assessment.
Timepoint [2] 329353 0
Baseline, 3 months and 6 months.
Secondary outcome [3] 329356 0
Nutrition will be measured by some questions from the NSW Population Health Survey and a question developed specifically for this study.
Timepoint [3] 329356 0
Baseline, 3 months and 6 months.
Secondary outcome [4] 329357 0
Smoking will be measured using a question from the WHO STEPS Instrument and a question developed specifically for this study.
Timepoint [4] 329357 0
Baseline, 3 months and 6 months.
Secondary outcome [5] 329364 0
Quality of life will be measured using the Short Form 12-item health survey (SF12v2)
Timepoint [5] 329364 0
Baseline, 3 months and 6 months.
Secondary outcome [6] 329365 0
Nutrition self-efficacy will be measured using a question developed specifically for this study.
Timepoint [6] 329365 0
Baseline, 3 months and 6 months.
Secondary outcome [7] 329366 0
Physical activity self-efficacy will be measured using a question developed specifically for this study.
Timepoint [7] 329366 0
Baseline, 3 months and 6 months.
Secondary outcome [8] 329368 0
Medication adherence will be measured using a question developed specifically for this study.
Timepoint [8] 329368 0
Baseline, 3 months and 6 months.
Secondary outcome [9] 332278 0
Total cholesterol will be collected via pathology requests.
Timepoint [9] 332278 0
Baseline, 3 months and 6 months.
Secondary outcome [10] 332279 0
Low density lipoprotein cholesterol will be collected via pathology requests.
Timepoint [10] 332279 0
Baseline, 3 months and 6 months.
Secondary outcome [11] 332280 0
High density lipoprotein cholesterol will be collected via pathology requests.
Timepoint [11] 332280 0
Baseline, 3 months and 6 months.
Secondary outcome [12] 332281 0
Triglycerides will be collected via pathology requests.
Timepoint [12] 332281 0
Baseline, 3 months and 6 months.
Secondary outcome [13] 332284 0
Diabetes management self-efficacy will be measured using a question developed specifically for this study.
Timepoint [13] 332284 0
Baseline, 3 months and 6 months.

Eligibility
Key inclusion criteria
People 18 years and older who have a mobile phone
People with type 2 diabetes (HbA1c7.0% or above)
People who can read and speak English
People who have received medical clearance from their doctor
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who are pregnant.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 294989 0
Government body
Name [1] 294989 0
Translational Research Grants Scheme, NSW Ministry of Health
Address [1] 294989 0
NSW Ministry of Health
73 Miller Street,
North Sydney NSW 2060
Country [1] 294989 0
Australia
Primary sponsor type
Individual
Name
Dr Susan Furber
Address
Illawarra Shoalhaven Local Health District
Locked Bag 9
Wollongong NSW 2500
Country
Australia
Secondary sponsor category [1] 293809 0
None
Name [1] 293809 0
Address [1] 293809 0
Country [1] 293809 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296344 0
Joint University of Wollongong and Illawarra Shoalhaven Local Health District Medical Human Research Ethics Committee (EC00150)
Ethics committee address [1] 296344 0
Ethics Unit, Research Services Office
Building 20, Level 1
University of Wollongong
Northfields Ave
Wollongong NSW 2522
Ethics committee country [1] 296344 0
Australia
Date submitted for ethics approval [1] 296344 0
12/09/2016
Approval date [1] 296344 0
25/10/2016
Ethics approval number [1] 296344 0
HE16/343

Summary
Brief summary
The aim of this study is to determine the effectiveness of a text message intervention on lifestyle risk factor modification and diabetes self-management for people with type 2 diabetes.
A pragmatic randomised controlled trial will be conducted in New South Wales. The intervention group will receive mobile phone text messages for 6 months; the messages will provide information, motivation and support on physical activity, nutrition, weight, smoking cessation and diabetes self-management. The control group will receive usual care.
The primary outcome measure will be HbA1c; secondary measures will include physical activity, nutrition, body mass index, blood lipids, and medication adherence.
A sample of 340 will be needed in the trial. People will be recruited through various sources such as the Illawarra Shoalhaven Local Health District (Ambulatory and Primary Health Care, hospitals & the Diabetes Service), general practices, local newspapers, pharmacists, podiatrists, and Diabetes NSW.
People will be eligible to participate if they: have type 2 diabetes (HbA1c 7.0% or above); have a mobile phone; are 18 years or older; able to read and speak English; and have medical clearance from their doctor. Exclusion criterion will be pregnancy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70510 0
Dr Susan Furber
Address 70510 0
Illawarra Shoalhaven Local Health District
Locked Bag 9
Wollongong NSW 2500
Country 70510 0
Australia
Phone 70510 0
+61 2 42216729
Fax 70510 0
Email 70510 0
susan.furber@health.nsw.gov.au
Contact person for public queries
Name 70511 0
Ms Karen Waller
Address 70511 0
Illawarra Shoalhaven Local Health District
Locked Bag 9
Wollongong NSW 2500
Country 70511 0
Australia
Phone 70511 0
+61 2 42216723
Fax 70511 0
Email 70511 0
karen.waller@health.nsw.gov.au
Contact person for scientific queries
Name 70512 0
Dr Susan Furber
Address 70512 0
Illawarra Shoalhaven Local Health District
Locked Bag 9
Wollongong NSW 2500
Country 70512 0
Australia
Phone 70512 0
+61 2 42216729
Fax 70512 0
Email 70512 0
susan.furber@health.nsw.gov.au

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?
Ethical approval
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary