The BABY STEPS study
Research type
Research Study
Full title
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.
IRAS ID
210608
Contact name
Kamlesh Khunti
Contact email
Sponsor organisation
University of Leicester
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Research Summary
Gestational diabetes is a type of diabetes that can develop during pregnancy. It poses a threat to mother and child; women with gestational diabetes are seven times more likely to develop type 2 diabetes within 10 years. Research shows that structured education programmes can improve cardiovascular disease risk profiles and thus be beneficial for a patient’s future health and for health care professionals. Therefore, the aim of the study is to implement and evaluate a structured education programme with additional support (wrist-worn activity monitor linked to an interactive website).The study will be a two-group, parallel randomised controlled trial of women who have had gestational diabetes in their most recent pregnancy. The women will be up to 36 months post birth at point of recruitment and will be at increased risk of developing type 2 diabetes. The study will compare two groups - the intervention group will attend the structured education programme and the control group will be sent an information leaflet.
Increased physical activity is the main outcome for this study, as an increase of around 30 minutes per day, is thought to be sufficient to reduce the onset of type 2 diabetes. A sample of 290 women will be sought across two sites: University Hospitals of Leicester and George Eliot Hospital. The intervention will last 12 months. To assess the effectiveness of the intervention data primary and secondary outcome data collected at baseline will be compared with follow-up data collected at 6 month and 12 month.
Summary of Results
Women with gestational diabetes have a seven-fold increase in risk of developing type 2 diabetes within 10 years and there is observational evidence suggesting that an active lifestyle is associated with a reduced risk of progression from gestational diabetes to type 2 diabetes. The aim of the study was to investigate whether a structured group education programme with an accompanying mobile web application can lead to improvements in objectively measured average daily physical activity at 12 months.The study was a randomised controlled trial. Women aged 18 years and over with a history of gestational diabetes in the previous five years, were recruited. They were randomised to either the control group (given an information leaflet) or the intervention group (invited to attend two group education sessions and provided with access to mobile web application). The intervention provided information in various formats about the importance of a healthy lifestyle, in particular the importance of being physically active. Participants wore an accelerometer for eight days at the beginning of the study and then again at 6 months and 12 months into the study. This provided data on whether physical activity changed in the two groups.
The study recruited to target with 293 women consenting to take part. Of these, 144 were randomised to the intervention arm and 149 to the control arm. The average age was 35 years and 40% of the participants were from an ethnic minority group. 116 (81%) of those in the intervention group attended the first session of the group programme, and 109 (76%) attended both sessions. The intervention group increased their physical activity by the equivalent of approximately 500 steps per day, but this difference was not statistically significant. There were significant improvements self-efficacy-for-exercise scores, anxiety levels and quality of life in the intervention group.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
16/EM/0488
Date of REC Opinion
30 Dec 2016
REC opinion
Further Information Favourable Opinion