None listed
Conditions
Brief summary
OptimalMe is a digitally enabled antenatal lifestyle intervention being implemented across one large Australian public health service, comprising three hospitals, to optimise gestational weight gain and related health outcomes. Using a stepped-wedge hybrid Type III design, the primary evaluation outcome includes implementation reach, fidelity, adoption, and cost-effectiveness. Secondary outcomes include gestational weight gain and routinely collected maternal–neonatal outcomes. All pregnant women >18 years, carrying a singleton pregnancy and not receiving specialist high-risk pregnancy care will receive access to a digital healthy lifestyle website (opt-in and self-selecting), with higher-risk women additionally receiving three structured telehealth coaching sessions of 30 minutes duration (opt-out as per routine care). Findings will provide real-world evidence on the feasibility and scalability of embedding digital lifestyle support into routine antenatal care for broad, public health benefit.
Interventions
The OptimalMe program is a quality assurance initiative that will be implemented as part of routine antenatal care. All women booking for maternity care within the health service will be offered access to a digital platform, OptimalMe. OptimalMe provides evidence-based information (i.e. pregnancy health information factsheets for common conditions, concerns or outcomes - including but not limited to: heartburn and reflux, constipation, fibre intake, gestational diabetes, hypertensive disorders, caesarean delivery, preparing for labour, anxiety and depression, feeding your baby) and tools related to healthy eating (i.e. tools to assess dietary intake with feedback provided against National Dietary guidelines for pregnancy, healthy eating and food safety guides for pregnancy), physical activity (i.e. tools that capture physical activity levels with feedback provided against National Physical Activity guidelines for pregnancy), gestational weight gain monitoring (i.e. a gestational weight gain calculator and interactive graph), goal setting activities, and self-monitoring (i.e. a symptom tracker and baby development and stages tracker) throughout pregnancy. The platform is designed to support self-management and behaviour change during pregnancy and can be accessed remotely by participants in their own home or preferred setting. Any woman who is over the age of 18 and carrying a singleton pregnancy can access the website and those that self-select as not meeting these criteria will be redirected to standard care resources. There is no requirement on the frequency of use of the website and in line with standard care, although women will be encouraged to use the website, it is not compulsory. In addition to the website offering, all women considered at higher risk, defined as women with a body mass index equal to or higher than 25.00kg/m2, aged over 18 years and carrying a singleton pregnancy and not experiencing a condition or complication preventing receipt of coaching (i.e. under the care of the Adolescent, Drug and Psychological Pregnancy Team or Maternal-Fetal Medicine team for complex, very high risk pregnancies), will receive three health coaching sessions, in line with our previous antenatal clinical implementation (ACTRN1262000098598). Individual health coaching sessions are opt-out and hence considered as part of routine care. Sessions will be delivered virtually via telehealth by trained allied health professionals experienced in lifestyle behaviour change support approximately 6–8 weeks apart commencing between 12-15 weeks gestation. Each session is approximately 30 minutes in duration and is integrated into routine antenatal care. The health coaching component focuses on providing standard healthy lifestyle information related to pregnancy (i.e. Dietary and Physical Activity guidelines for pregnancy, gestational weight gain recommendations) and behaviour change strategies including goal setting, action planning, problem solving, relapse prevention, and self-management skills. The intervention is informed by recommendations including National Academy of Medicine guidelines for gestational weight gain, the Australian Pregnancy Care Guidelines, the Australian Dietary Guidelines (pregnancy and breastfeeding), and the Australian Physical Activity guidelines (pregnancy). Pregnant individuals are encouraged to self-monitor behaviours and gestational weight gain through the digital platform and coaching sessions. Adherence is monitored through platform engagement and clinical attendance audits. Women are typically booked for their first maternity care appointment between 10-15 weeks gestation and the intervention will continue from this point (i.e. when offered access to the OptimalMe website) through to birth (i.e. approximately 30 weeks duration). The design is an implementation, quality assurance initiative whereby implementation occurs at the level of the hospital site within the health service. There are three hospital sites and sequential step-wise rollout will occur according to the level of acuity at each hospital - from the lowest risk hospital site to the highest risk, tertiary hospital to minimise contamination (i.e. patients typically transferred from lower risk to higher risk care, if required). Using the minimal criteria above, all eligible women will be offered access to the website (uptake optional) and will receive health coaching (opt-out consent).
Sponsors
Study design
Eligibility
Inclusion criteria
This implementation initiative has minimal exclusion criteria, including women under the age of 18 and/or carrying a multiple pregnancy. All eligible pregnant women will receive access to the OptimalMe digital platform during the implementation phase, according to site-specific rollout dates. In addition, women with a body mass index (BMI) of 25 kg/m² or greater will telehealth health coaching sessions as part of an opt-out consent process.
Exclusion criteria
Women will be excluded if they have multiple pregnancies (e.g. twins or higher-order gestations). In addition, eligibility for the health coaching component is restricted to women with a BMI =25 kg/m²; therefore, women with a BMI <25 kg/m² will be excluded from this component but are still be eligible to access the OptimalMe digital platform as part of routine implementation. Finally, women that have a high-risk medical conditions that require specialised obstetric or medical management during pregnancy involving transfer to a high risk tertiary hospital site will be discharged from health coaching.