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. 2018 Dec 12;19(1):682.
doi: 10.1186/s13063-018-3067-8.

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

Nithya Sukumar  1   2 , Helen Dallosso  3 , Ponnusamy Saravanan  1   2 , Tom Yates  4   5 , Carol Telling  3 , Karen Shorthose  6 , Alison Northern  3 , Sally Schreder  3 , Christopher Brough  3 , Laura J Gray  7 , Melanie J Davies  4   5 , Kamlesh Khunti  8   9
Affiliations

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

Nithya Sukumar et al. Trials. .

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.

Keywords: Diabetes prevention; Gestational diabetes; Patient education; Randomised controlled trial; Self-management.

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Conflict of interest statement

Ethics approval and consent to participate

The trial is sponsored by the University of Leicester (sponsor representative is Dr. Michelle Mueller; uolsponsor@le.ac.uk). Ethical approval was granted on 11 March 2017 by the East Midlands Derby Research Ethics Committee (16/EM/0488) and the Health Research Authority. Written informed consent is provided by the participant before any study data are collected.

Consent for publication

The manuscript does not contain any person’s individual data in any form.

Competing interests

KK, MJD and TY were members of the NICE Public Health Guideline (PH38) Type 2 diabetes: prevention in people at high risk. Other authors declared no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Consort flow diagram
Fig. 2
Fig. 2
Schedule of enrolment, interventions and assessments as per SPIRIT 2013
See this image and copyright information in PMC

References

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