Exploring the Bump2Baby and Me trial
The journey through pregnancy and motherhood can be an incredible and transformative experience for women. However, it can also bring about big life changes and various challenges, particularly for those who develop pregnancy related conditions like gestational diabetes. Understanding experiences and how lifestyle can change during this time is essential in order to provide comprehensive support for women. As the Bump2Baby and Me randomised controlled trial (RCT) covers an 18-month period, from pregnancy to postpartum, we are well-placed to explore different factors during pregnancy and postpartum. This blog will delve into the details of what information is collected in the trial, its timeline, and the valuable outcomes it aims to achieve.
The Bump2Baby and Me RCT (also referred to as the study) involves 865 pregnant women who are at a higher risk of developing gestational diabetes during their pregnancy, identified through the Monash GDM Risk Screening tool. These women were recruited from Dublin (Ireland), Granada (Spain), Bristol (UK), and Melbourne (Australia). Interested women were then randomly assigned to either usual care or usual care plus the Bump2Baby and Me mHealth Coaching Programme. Women joined the trial around 14 weeks’ gestation, ensuring early engagement.
The trial intervention
The core of the project and the intervention being tested is the Bump2Baby and Me mHealth Coaching Programme, delivered through a user-friendly phone app. This innovative platform with live health coaches offers continuous support, guidance, and valuable resources to women throughout their pregnancy journey and the first year of their child’s life. The Programme is designed to empower women, providing them with the knowledge and tools to make informed decisions about their health and well-being.
Trial timeline and information collected
The Bump2Baby and Me project began in January 2020 and is set to conclude in December 2024. The first year was dedicated to preparation and setup of the trial which then began in 2021 across the four countries. Recruitment of participants took place between February 2021 and April 2022. The last baby was born in September 2022 and the final 12-month visit will be in September 2023.
Data collection occurs at multiple time points to comprehensively assess various aspects of maternal and infant health. These time points include the start of pregnancy, during pregnancy, at birth, then at 3, 6, 9, and 12 months’ postpartum.
The collected data encompasses a wide range of outcome measures, including
- gestational weight gain;
- maternal blood pressure;
- maternal and infant physical activity;
- maternal and infant sleep;
- maternal psychological health;
- maternal and infant diet;
- metabolic markers such as blood sugar;
- newborn and infant anthropometry (body proportions and measurements);
- breastfeeding patterns;
- infant neurological development.
As the study progresses with all participants well into the postpartum stage, participants continue to engage with the trial and provide important data. Regular weight recordings are collected by participants using digital scales provided to monitor postpartum weight. Maternal psychological health and wellbeing is recorded every three months along with sleep quality. Infant feeding and breastfeeding is assessed through questionnaires that inquire about the history and experience of feeding, pumping, and timing over the three month intervals. Mothers also report measurements of infant weight, length, and head circumference, providing valuable insights into the growth and development of their infants.
12-Month Postpartum Assessment
At the pivotal 12-month postpartum mark, participants and their infants attend a final study visit. This visit allows for comprehensive measurements, including the assessment of infant length, weight, and head circumference using calibrated tools. Additionally, maternal height, weight, and blood pressure are recorded, and a blood sample taken. Participants are also requested to complete additional questionnaires online in the week leading up to the appointment, further contributing to the valuable data collection and evaluation process.
The Bump2Baby and Me mHealth Coaching Programme is an innovative and promising initiative aimed at revolutionising maternal health and well-being. By empowering women with knowledge, support, and guidance through pregnancy and postpartum, the project seeks to improve numerous outcomes related to gestational diabetes, weight management, sleep, psychological health, diet, and infant development.
The comprehensive data collection process, encompassing various time points and outcome measures, will provide invaluable insights into the effectiveness and impact of this intervention. With its global reach and cross-cultural design, the Bump2Baby and Me project has the potential to pave the way for personalised and accessible mHealth solutions, ultimately enhancing the journey of pregnancy and motherhood for countless women worldwide and improving the future health of them and their children.