Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000067471
Ethics application status
Approved
Date submitted
20/10/2015
Date registered
21/01/2016
Date last updated
14/01/2019
Date data sharing statement initially provided
14/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
SMART Phones for SMART Mums: a pilot interactive smart phone program for women following gestational diabetes
Scientific title
Efficacy of a pilot interactive smart phone program in improving adherence to healthcare guidelines following gestational diabetes.
Secondary ID [1] 287710 0
None
Universal Trial Number (UTN)
Trial acronym
SMART Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational Diabetes 296542 0
Condition category
Condition code
Metabolic and Endocrine 296804 296804 0 0
Diabetes
Reproductive Health and Childbirth 297549 297549 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will be recruited during a gestational diabetes pregnancy. However, the active intervention will commence from the time of discharge from hospital. Intervention subjects will be given guidelines to follow (standard post gestational diabetes booklet from Diabetes Australia), a Fitbit wrist band activity monitor (to be worn continuously), and a telephone lifestyle counselling session with a dietician (of no more than 1 hour duration) at 6-10 weeks post-partum. They will subsequently receive 3-4 semi-personalised and culturally sensitive SMS messages per week, to provide advice, motivation, information and support with a focus on addressing and overcoming known barriers to behaviour change. The SMS messages will be spaced 1-2 days apart. They will have the opportunity to have further contact with the lifestyle counsellor if required by telephone, SMS or email. Data from the activity monitor will be visible to the subject, but also downloaded centrally via the internet and thus accessible to the investigators. This will enable monitoring of physical activity which will also be fed back into the SMS messaging. The intervention goes for 6 months from the initial counselling session, in the post-partum period.
Intervention code [1] 293096 0
Lifestyle
Intervention code [2] 293097 0
Behaviour
Comparator / control treatment
Subjects randomized to Control will receive standard paper based advice regarding healthy lifestyle following gestational diabetes. They will be contacted at 12 weeks to remind them to have a glucose tolerance test, and to be encouraged to remain in the study for the full 8 months (6 months + additional 2 months to factor in the delay before lifestyle counselling in the intervention group).
Control group
Active

Outcomes
Primary outcome [1] 296401 0
The proportion of women in each group meeting physical activity recommendations. Measured by Fitbit activity monitor and the Active Australia Questionnaire.
Timepoint [1] 296401 0
6 months after lifestyle counselling session (8 months post-partum for controls)
Primary outcome [2] 296402 0
The proportion of women in each group attending their post-partum glucose tolerance testing within 12 weeks post-partum. Based on self-report and confirmation of the test result.
Timepoint [2] 296402 0
12 weeks
Primary outcome [3] 297105 0
The proportion of women in each group meeting dietary macronutrient recommendations for fat, fibre, and carbohydrate intake, as per the NHMRC's Australian Dietary Guidelines (2013). Measured by 24 hour food recall and food diary.
Timepoint [3] 297105 0
6 months after lifestyle counselling session (8 months post-partum for controls)
Secondary outcome [1] 318348 0
change in self-reported weight between each group
Timepoint [1] 318348 0
6 months after lifestyle counselling session (8 months post-partum for controls)
Secondary outcome [2] 318349 0
the proportion who breast feed based on self-report
Timepoint [2] 318349 0
6 months after lifestyle counselling session (8 months post-partum for controls)
Secondary outcome [3] 318352 0
The acceptability of the SMS messaging system, using a qualitative and semi-quantitative questionnaire designed for this study.
Timepoint [3] 318352 0
6 months after lifestyle counselling session (8 months post-partum for controls)
Secondary outcome [4] 320031 0
the duration of breast-feeding among women in each group, based on self-report
Timepoint [4] 320031 0
6 months after lifestyle counselling session (8 months post-partum for controls)

Eligibility
Key inclusion criteria
i) Have gestational diabetes
ii) own a smart mobile phone with SMS capability
iii) have internet access
iv) have sufficient skill in English language to read text messages
v) be physically capable of performing moderate intensity physical activity
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Having a comorbidity where moderate physical activity is inappropriate or not practical.
Have pre-existing diabetes
Already uses an activity monitor

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a pilot study. Primary analysis will be by intention to treat. Continuous variables will be analysed by analysis of variance or the Mann Whitney U test, and dichotomous variables by the chi square test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2016
Actual
14/04/2016
Date of last participant enrolment
Anticipated
31/03/2017
Actual
15/05/2017
Date of last data collection
Anticipated
30/03/2018
Actual
30/03/2018
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 4494 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 10687 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 292257 0
Charities/Societies/Foundations
Name [1] 292257 0
Australian Diabetes Society
Country [1] 292257 0
Australia
Primary sponsor type
Individual
Name
N Wah Cheung
Address
Dept of Diabetes & Endocrinology
Westmead Hospital
Cnr of Hawkesbury and Darcy Rds
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 290931 0
None
Name [1] 290931 0
None
Address [1] 290931 0
None
Country [1] 290931 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293722 0
Western Sydney LHD Human Research Ethics Committee
Ethics committee address [1] 293722 0
Ethics committee country [1] 293722 0
Australia
Date submitted for ethics approval [1] 293722 0
30/07/2015
Approval date [1] 293722 0
16/09/2015
Ethics approval number [1] 293722 0
(4316) AU RED HREC/15/WMEAD/244

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61094 0
Prof Ngai Wah Cheung
Address 61094 0
Dept of Diabetes & Endocrinology
Westmead Hospital
Cnr of Hawkesbury and Darcy Rds
Westmead, NSW 2145
Country 61094 0
Australia
Phone 61094 0
61 02 98456796
Fax 61094 0
Email 61094 0
[email protected]
Contact person for public queries
Name 61095 0
N Wah Cheung
Address 61095 0
Dept of Diabetes & Endocrinology
Westmead Hospital
Cnr of Hawkesbury and Darcy Rds
Westmead, NSW 2145
Country 61095 0
Australia
Phone 61095 0
61 02 98456796
Fax 61095 0
Email 61095 0
[email protected]
Contact person for scientific queries
Name 61096 0
N Wah Cheung
Address 61096 0
Dept of Diabetes & Endocrinology
Westmead Hospital
Cnr of Hawkesbury and Darcy Rds
Westmead, NSW 2145
Country 61096 0
Australia
Phone 61096 0
61 02 98456796
Fax 61096 0
Email 61096 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
confidentiality


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
SourceTitleYear of PublicationDOI
EmbaseA pilot randomised controlled trial of a text messaging intervention with customisation using linked data from wireless wearable activity monitors to improve risk factors following gestational diabetes.2019https://dx.doi.org/10.3390/nu11030590
N.B. These documents automatically identified may not have been verified by the study sponsor.