BABYSTEPS
A randomised controlled trial to investigate the effect of a structured education programme on women who have had gestational diabetes and are at risk of developing type 2 diabetes.
study title
Background
Gestational diabetes is a type of diabetes that arises during pregnancy. It is associated with poor health outcomes in both mother and child and at least a seven-fold increase in risk of developing type 2 diabetes within 10 years. Lifestyle interventions have been shown to reduce the risk of incident type 2 diabetes in adults with impaired glucose tolerance, including in women with a history of gestational diabetes.
Study Aims
The aim of the study was to implement and evaluate a group structured education programme and accompanying online mobile web app that met the social and cultural needs of women with a history of gestational diabetes and to evaluate the programme in terms of its impact on physical activity.
Study Summary
The study was a two-group (1:1), parallel randomised controlled trial of women who had had gestational diabetes during any pregnancy up to 60 months prior to the point of recruitment and are therefore at risk of developing type 2 diabetes. It was conducted in two sites in the UK - University Hospitals of Leicester NHS Trust and George Eliot Hospital NHS Trust. Women aged 18 or over, willing and able to attend the clinic and education sessions and able to speak and read English sufficiently to give informed consent and follow the education programme were eligible to take part.
Study Progress
293 women (35.1±5.1 years; 40% ethnic minority) were recruited to the study. A paper describing the results is currently under review.
Funding and Sponsorship
The project was jointly funded by the National Institute for Health Research (NIHR), Collaboration for Leadership in Applied Health Research and Care (CLAHRC) East Midlands, now recommissioned as the NIHR Applied Research Collaboration East Midlands (ARC EM) and the NIHR CLAHRC West Midlands. There was additional funding from the East Midlands Academic Health Science Network (EMAHSN). The study was sponsored by the University of Leicester.
Study Publications
Sukumar N, Dallosso H, Saravanan P, Yates T, Telling C, Shorthose K, Northern A, Schreder S, Brough C, Gray LJ, Davies M, Khunti K Baby Steps – a structured group education programme with accompanying mobile web application designed to promote physical activity in women with a history of gestational diabetes: study protocol for a randomised controlled trial. Trials. 2018;19:682. https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-3067-8
Ekezie W, Dallosso H, Saravanan P, Khunti K and Hadjiconstantinou M Experiences of using a digital type 2 diabetes prevention application designed to support women with previous gestational diabetes. BMC Health Services Research, 2021, 21:772
https://doi.org/10.1186/s12913-021-06791-9
Research Team
Principal Investigators: Prof Kamlesh Khunti and Prof Saravanan Ponnusamy
Project Managers: Patrick Highton (ph204@leicester.ac.uk)
ISRCTN Registry ISRCTN 17299860 https://doi.org/10.1186/ISRCTN17299860