A target sample size of 60 women will be recruited to assess the feasibility and acceptability of the +Stay Active intervention for managing .
The intervention combines with a smartphone app designed to increase physical activity levels.
Participants will use a wrist accelerometer to monitor their physical activity before and after engaging with the app.
Primary outcomes include recruitment rates, retention, compliance, and participant engagement with the intervention.
Secondary outcomes focus on blood glucose control, self-reported and device-measured physical activity, and participant feedback on the app.
Insights gained will inform the design of a future randomized controlled trial.
Simplified
INTRODUCTION: Physical activity (PA) interventions have a promising role in the management of (GDM). Digital technologies can support PA at scale and remotely. The protocol describes a study designed to determine the feasibility and acceptability of a complex intervention; known as +Stay Active. +Stay Active combines with a bespoke behaviour change informed smartphone application (Stay-Active) to augment PA levels in women with GDM.
METHODS AND ANALYSIS: This is a non-randomised feasibility study using a mixed methods approach. Participants will be recruited from the GDM antenatal clinic at the Women Centre, John Radcliffe Hospital, Oxford. Following baseline assessments (visit 1) including self-reported and device determined PA assessment (wearing a wrist accelerometer), women will be invited to participate in an online motivational interview, then download and use the Stay-Active app (Android or iOS) (visit 2). Women will have access to Stay-Active until 36 weeks gestation, when engagement and PA levels will be reassessed (visit 3). The target sample size is 60 women. Primary outcomes are recruitment and retention rates, compliance and assessment of participant engagement and acceptability with the intervention. Secondary outcomes are assessment of blood glucose control, self-reported and device determined assessment of PA, usage and structured feedback of participant's attitudes to +Stay Active, assessment of health costs and description of maternal and neonatal outcomes. This study will provide key insights into this complex intervention regarding engagement in smartphone technology and the wearing of accelerometers. These data will inform the development of a randomised controlled trial with refinements to intervention implementation.
ETHICS AND DISSEMINATION: The study has received a favourable opinion from South Central-Hampshire B Research Ethics Committee; REC reference: 20/SC/0342. Written informed consent will be obtained from all participants. Findings will be disseminated through peer-reviewed journals, conferences and seminar presentations.
TRIAL REGISTRATION NUMBER: ISRCTN11366562.
Key numbers
60 women
Target Sample Size
Women with gestational diabetes will be recruited for the study.
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Competing interests: LHM, JEH, MM, YK, RS, NW and JB are supported by the NIHR Oxford Biomedical Research Centre. LHM is a part-time employee of EMIS Group plc. LT is a Non-Executive Director, part-time employee and shareholder of Sensyne Health plc. JEH is funded by a UKRI Future Leaders fellowship. The remaining authors have no disclosures of interest and there are no other conflicts to declare.
