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Trial registered on ANZCTR


Registration number
ACTRN12620000615987
Ethics application status
Approved
Date submitted
2/03/2020
Date registered
27/05/2020
Date last updated
27/05/2020
Date data sharing statement initially provided
27/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
SMART MUMS WITH SMART PHONES 2 (SMs2)
Text messaging support for women after gestational diabetes
Scientific title
A multicentre, open label, active control, randomised controlled trial to determine the comparative effectiveness of a customised mobile phone text messaging intervention for women post-gestational diabetes, supported by data from activity monitors, compared to activity monitors alone, for improving the diabetes risk factors of weight, physical activity, and diet.
Secondary ID [1] 300461 0
NA
Universal Trial Number (UTN)
NA
Trial acronym
SMs2
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Gestational Diabetes Mellitus (GDM) 316128 0
Prevention of diabetes 316431 0
Condition category
Condition code
Metabolic and Endocrine 314419 314419 0 0
Diabetes
Reproductive Health and Childbirth 314834 314834 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention comprises a patient-centred lifestyle program via semi-personalised and customised mobile phone text messages, facilitated by the use of an activity monitor which is integrated with the texting through the use of activity data. The intervention commences after giving birth.

Participants with GDM will be recruited when attending hospital clinics. Three hospitals will participate in this multicentre study, namely Westmead, Blacktown, and Campbelltown Hospitals. Participants will be randomised in a 1:1 ratio to usual care plus activity monitor (active Control) or usual care plus integrated DHI (Intervention), comprising wrist worn activity monitor (Garmin Vivofit 4) and customised education and support delivered via text messaging, and followed for 6 months. The intervention is entirely administered by the customised text messaging program.

Text Messages: Following delivery, participants randomised to intervention will receive up to 4 messages a week, and this will continue until 6 months post-partum.
Messages will be sent at random times between 9 am and 5 pm during weekdays.

Content of Messages: The 4 messages each week will be related to i) physical activity (PA), ii) healthy eating iii) parenting, breast-feeding and infant health, iv) the activity monitor. The sequence of messages will be structured such that initial messages will focus more on issues relevant to early parenting, but over time the focus will shift more to long-term maternal healthy lifestyle. Early lifestyle messages will also promote adoption of healthy lifestyle behaviour, whilst later messages will concentrate on supporting maintenance of changes. The PA messages will be structured to gradually motivate the women to achieve at least 5 days of >10000 steps/day each week, and 30 minutes of at least moderate-intensity activity on most days. The dietary messages will support the Australian Dietary Guidelines and healthy eating to reduce weight and diabetes risk. Parenting and infant health messages will address issues such as breast-feeding, weaning, infant care, sleep, allergies and mental health support.

Message Customisation: Customisation will occur at 2 different levels. 1) Initial customisation will be on baseline variables including breast-feeding and cultural background. This will be based on characteristics recorded at baseline, but may be modified by a change in breastfeeding status 2) Activity specific customisation (below).

Customisation based on the Activity Monitor: Physical activity coaching will be individually customised through the activity monitor feeding data to the text messaging engine, so that the women will receive a weekly text message with adaptive step targets, encouragement, and reminders based on their activity monitor data, as successfully tested in our pilot study. For the first 10 weeks post-partum, the daily step target will be set at 3500. Using a rank order percentile algorithm, adaptive steps targets will be set weekly based on the step counts from the previous 2 weeks. An incremental daily step target will therefore be set each week based on the number of steps taken in the previous 2 weeks. The maximum target is 10,000 steps a day. Text messages will also remind women to synchronise their activity monitor if needed.

The upload of Garmin data will enable the adaptive step algorithm, but also provide data for the monitoring of step count and activity monitor use.
Intervention code [1] 316755 0
Treatment: Other
Intervention code [2] 316756 0
Lifestyle
Comparator / control treatment
All Active Control participants will receive usual care as required through their family doctor and community health services. They will be given an activity monitor but no other intervention nor messaging related to their activity monitor. They will receive a small number of messages over the 26 weeks related to the evaluations. They will also receive the “Life After GDM” booklet which is routinely sent to all women registered in the National Diabetes Services Scheme as having GDM by Diabetes Australia after their pregnancy. They will only receive a welcome text message, and administrative messages such as requests to complete surveys for the evaluation, but not the intervention messages.
Control group
Active

Outcomes
Primary outcome [1] 322763 0
The primary outcome of the study is the “Healthy Lifestyle Outcome” (HLO) composed of weight, dietary and PA outcomes. The HLO is met if 2 of the following 3 components are achieved:
A) Weight: reaching pregravid weight if pregravid BMI was <25 or losing 5% of pregravid weight if pregravid BMI was >=25, This will be self-reported.
B) Physical Activity: Whether Australian guidelines of 150 minutes of moderate intensity PA each week have been met. This is measured through the Active Australia Questionnaire.
C) Fruit & Vegetables: Whether 1 serve of fruit and 3 serves of vegetables are consumed per day and discretionary foods are consumed <=14 times a week. This is measured through a short diet survey, specifically designed for the study.
Timepoint [1] 322763 0
Evaluated at 6 and 12 months
Secondary outcome [1] 379630 0
Body Mass Index (BMI), based on height recorded during antenatal visits, and self-reported weight.
Timepoint [1] 379630 0
26 weeks, 52 weeks
Secondary outcome [2] 379631 0
Mean changes compared to baseline in weekly minutes of moderate and vigorous physical activity, measured by the self-completed Active Australia Questionnaire (AAQ)
Timepoint [2] 379631 0
26 weeks, 52 weeks
Secondary outcome [3] 379632 0
Whether Australian Dietary Guideline recommendations of consumption of >=2 serves of fruit, >=5 serves of vegetables and of discretionary foods <=14 times a week have been met; measured using the dietary questionnaire designed for the study/
Timepoint [3] 379632 0
26 weeks, 52 weeks
Secondary outcome [4] 379633 0
Duration and intensity of breast feeding measured by a customised breast feeding survey for this study.
Timepoint [4] 379633 0
4 weeks, 26 weeks, 52 weeks
Secondary outcome [5] 379634 0
Likelihood of postnatal depression as assessed by the Edinburgh Postnatal Depression Scale (EPDS)
Timepoint [5] 379634 0
26 weeks, 52 weeks
Secondary outcome [6] 379636 0
Sustainability of Garmin Vivofit4 activity monitor use, i.e. whether women continue to use their activity monitors as determined from data uploads when activity monitors are synchronised with mobile phones
Timepoint [6] 379636 0
4 weeks, 12 weeks, 26 weeks, 52 weeks
Secondary outcome [7] 379637 0
Step count based on data from the activity monitor
Timepoint [7] 379637 0
4 weeks, 12 weeks, 26 weeks, 52 weeks
Secondary outcome [8] 379638 0
Whether a post-partum GTT has been performed by 12 weeks as per Australian guidelines. This will be determined by self-report and pathology reports.
Timepoint [8] 379638 0
12 weeks
Secondary outcome [9] 379641 0
The incidence of dysglycaemia at 12 months. This is defined as the presence of any of the following:
a) Impaired Fasting Glucose (IFG), diagnosed on the basis of a fasting glucose level >=6.1 mmol/L
b) Impaired Glucose Tolerance (IGT), diagnosed on a 2 hour glucose level of 7.8-11.0 mmol/L on a 75g oral GTT
c) Prediabetes, diagnosed by the American Diabetes Association criteria of HbA1c 39-47 mmol/mol (5.7-6.4%)
d) Diabetes, diagnosed by standard criteria of fasting glucose >=7.0 mmol/L, or 2 hour glucose >=11.1 mmol/L on a GTT, or HbA1c >=48 mmol/mol (6.5%)

Timepoint [9] 379641 0
52 weeks
Secondary outcome [10] 381110 0
Sleep duration based on data from activity monitor
Timepoint [10] 381110 0
4 weeks, 12 weeks, 26 weeks, 52 weeks
Secondary outcome [11] 381272 0
Sleep quality as determined from the activity monitor
Timepoint [11] 381272 0
4 weeks, 12 weeks, 26 weeks, 52 weeks

Eligibility
Key inclusion criteria
1) have GDM diagnosed on the basis of local glucose tolerance test (GTT) criteria
2) own a smart phone with internet access
3) age >18 years
4) have adequate English literacy to read text messages
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1) already using an activity monitor
2) has pre-existing diabetes
3) has a GTT result in the “diabetes mellitus in pregnancy” range in the first 20 weeks of pregnancy (fasting glucose >=7.0 mmol/L or 2 hour glucose >=11.1 mmol/L)
4) on medications which affect glucose metabolism
5) twin pregnancy
6) significant fetal disorder likely to require increased care in first 6 months post-partum (eg major malformation, major inheritable disorder)
7) planning a pregnancy in next 6 months
8) planning to spend >1 month overseas within 6 months post-partum
9) unable to walk regularly due to physical limitations

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)
Allocation concealment will be achieved by central randomisation using computer random number generation to Intervention and Control on a 1:1 basis, stratified by site, BMI and ethnic background. The study team member who determined if a subject was eligible for inclusion in the trial will be unaware, when this decision iss made, to which group the subject would be allocated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised to Intervention (text messages and activity monitor) or Active Control (activity monitor only). Randomisation by computer random number generation to Intervention and Control on a 1:1 basis will occur, stratified by site, BMI and ethnic background.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The secure web-based Research Electronic Data Capture (REDCap) web application will be used for participant registration and data collection. Study staff will enter subject details into a REDCap form that will be accessible by study staff with username and password. Each subject will be assigned a unique study ID.

Following delivery, the local study coordinator will enter the date of delivery and revise eligibility. In the event of stillbirth, or a major maternal or fetal/neonatal complication whereupon the receipt of text messages would be inappropriate, no text messages will be sent and the participant will be discontinued from the study.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The primary analysis will be a multivariate log-binomial regression on the HLO at 6 months and the relative risk will be reported with a 95% confidence interval. Secondary outcomes will be analysed using log-binomial regression for binary outcomes and linear regression analysis for continuous variables. Heterogeneity analyses will examine the effectiveness of the intervention in different prespecified subgroups, such as age groups.

Recruitment
Recruitment status
Not yet 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
Recruitment hospital [1] 15778 0
Westmead Hospital - Westmead
Recruitment hospital [2] 15779 0
Blacktown Hospital - Blacktown
Recruitment hospital [3] 15780 0
Campbelltown Hospital - Campbelltown
Recruitment postcode(s) [1] 29213 0
2145 - Westmead
Recruitment postcode(s) [2] 29214 0
2148 - Blacktown
Recruitment postcode(s) [3] 29215 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 304875 0
Government body
Name [1] 304875 0
The Medical Research Futures Fund
Address [1] 304875 0
Department of Health
GPO Box 9848
Canberra ACT 2601
Australia
Country [1] 304875 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney, NSW, 2006
Country
Australia
Secondary sponsor category [1] 305214 0
None
Name [1] 305214 0
Address [1] 305214 0
Country [1] 305214 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305284 0
Western Sydney Local Health District Human Research Ethics Committee.
Ethics committee address [1] 305284 0
Western Sydney Local Health District Human Research Ethics Committee,
Westmead Hospital
Research and Education Network
Westmead NSW 2145
Ethics committee country [1] 305284 0
Australia
Date submitted for ethics approval [1] 305284 0
10/10/2019
Approval date [1] 305284 0
07/02/2020
Ethics approval number [1] 305284 0
2019/ETH13240

Summary
Brief summary
To evaluate in a randomised comparative effectiveness trial, whether a structured lifestyle modification program for women immediately after a GDM pregnancy, delivered via customised text messages and further individualised using data from activity monitors, improves diabetes risk factors, namely weight, physical activity (PA) and diet.
A diabetes prevention program of lifestyle modification delivered to mothers post-GDM pregnancy via customised mobile phone text messages and customised to diabetes risk factors as well as additional incoming data during the program from activity monitors, will promote the adoption of a healthier lifestyle and improve weight management.
Healthy lifestyle programs developed in intervention studies have generally been resource intensive and would not be easily accessible for many women at this stage of their lives. Our trial aims to use technology to establish a healthy lifestyle program which is affordable, sustainable and potentially transferable to health services. Successful widespread implementation of the program may have profound public health implications and impact on maternal health and the population prevalence of diabetes. Our targeted lifestyle program can be conducted at relatively little expense, but if dysglycaemia can be prevented or delayed, it may result in significant reductions in morbidity and cost savings to the health system.
Trial website
Trial related presentations / publications
Public notes
Publication arising from preceding pilot study: Cheung NW et al. A 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. Nutrients 2019; 11: 590.

Contacts
Principal investigator
Name 99882 0
Prof N Wah Cheung
Address 99882 0
Department of Diabetes & Endocrinology, Westmead Hospital, Westmead NSW 2145

Country 99882 0
Australia
Phone 99882 0
+61 02 98456796
Fax 99882 0
+61 02 96355691
Email 99882 0
wah.cheung@sydney.edu.au
Contact person for public queries
Name 99883 0
Prof N Wah Cheung
Address 99883 0
Department of Diabetes & Endocrinology, Westmead Hospital, Westmead NSW 2145
Country 99883 0
Australia
Phone 99883 0
+61 02 98456796
Fax 99883 0
+61 02 96355691
Email 99883 0
wah.cheung@sydney.edu.au
Contact person for scientific queries
Name 99884 0
Prof N Wah Cheung
Address 99884 0
Department of Diabetes & Endocrinology, Westmead Hospital, Westmead NSW 2145

Country 99884 0
Australia
Phone 99884 0
+61 02 98456796
Fax 99884 0
+61 02 96355691
Email 99884 0
wah.cheung@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Permission not been granted by ethics and governance
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 6786 0
Ethical approval
Citation [1] 6786 0
Link [1] 6786 0
Email [1] 6786 0
Other [1] 6786 0
Summary results
No Results