Sukumar, Nithya, Dallosso, Helen, Saravanan, Ponnusamy, Yates, Tom, Telling, Carol, Shorthose, Karen, Northern, Alison, Schreder, Sally, Brough, Christopher, Gray, Laura J, Davies, Melanie J and Khunti, Kamlesh (2018) 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, 19 (1). 682. doi:10.1186/s13063-018-3067-8 ISSN 1745-6215.
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Abstract
Background
A diagnosis of gestational diabetes (GDM) is associated with an over sevenfold increase in the risk of developing type 2 diabetes (T2D), while among parous women with T2D, up to 30% have a history of GDM. Lifestyle interventions have been shown to reduce the risk of incident T2D in adults with impaired glucose tolerance, including in women with a history of GDM. The aim of this study is to establish whether a group self-management education programme, supported by a mobile web application, can improve levels of physical activity at 12 months in women who have had GDM.
Methods
The study is a randomised controlled trial with follow-up at 6 and 12 months. Primary outcome is change in objectively measured average daily physical activity at 12 months. Secondary outcomes include lipid profile, blood pressure, glycated haemoglobin, obesity, smoking and alcohol status, self-reported physical activity, anxiety, depression and quality of life. Participants are recruited from maternity and diabetes departments in hospital trusts in two sites in the UK. Women aged > 18 years, with a diagnosis of GDM during any pregnancy in the previous 60 months are eligible. Participants need to have a good understanding of written and verbal English, be able to give informed consent and have access to a smart-phone. Women who are pregnant or have type 1 or type 2 diabetes are not eligible. In total, 290 participants will be recruited and randomly assigned, with stratification for age and ethnicity, to either the control group, receiving usual care, or the intervention group who are invited to participate in the Baby Steps programme. This comprises a group education programme and access to a mobile web application which provides an education component and interacts with a wrist-worn activity monitor providing automated messages, setting challenges and encouraging motivation.
Discussion
If effective, the Baby Steps programme could be translated into a primary care-based intervention that women with GDM are referred to in the postnatal period. This could help them make lifestyle changes that could reduce their future risk of T2D.
Trial registration
ISRCTN, ISRCTN17299860. Registered on 5 April 2017.
| Item Type: | Journal Article |
|---|---|
| Subjects: | R Medicine > RG Gynecology and obstetrics |
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Population, Evidence & Technologies (PET) Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
| SWORD Depositor: | Library Publications Router |
| Library of Congress Subject Headings (LCSH): | Diabetes in pregnancy -- Prevention, Exercise -- Health aspects |
| Journal or Publication Title: | Trials |
| Publisher: | Biomed Central |
| ISSN: | 1745-6215 |
| Official Date: | 12 December 2018 |
| Dates: | Date Event 12 December 2018 Published 21 November 2018 Accepted |
| Volume: | 19 |
| Number: | 1 |
| Article Number: | 682 |
| DOI: | 10.1186/s13063-018-3067-8 |
| Status: | Peer Reviewed |
| Publication Status: | Published |
| Access rights to Published version: | Open Access (Creative Commons open licence) |
| Copyright Holders: | © The Author(s). 2018 |
| Date of first compliant deposit: | 6 February 2019 |
| Date of first compliant Open Access: | 7 February 2019 |
| RIOXX Funder/Project Grant: | Project/Grant ID RIOXX Funder Name Funder ID |
| Related URLs: | |
| URI: | https://wrap.warwick.ac.uk/112907/ |
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