None listed
Conditions
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.
Interventions
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
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 breast-feeding but may be modified by a change in breastfeeding status, and 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.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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 to spend >1 month overseas within 6 months post-partum 8) unable to walk regularly due to physical limitations
Outcome results
None listed