Study protocol: use of a smartphone application to support the implementation of a complex physical activity intervention (+Stay Active) in women with gestational diabetes mellitus—protocol for a non-randomised feasibility study

Sep 28, 2022BMJ open

Using a smartphone app to help women with gestational diabetes follow a complex exercise program: plan for a non-randomized feasibility study

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Abstract

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.

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Key numbers

60 women
Target Sample Size
Women with gestational diabetes will be recruited for the study.

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