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
IntroductionPhysical activity (PA) interventions have a promising role in the management of gestational diabetes mellitus (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...
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Published in | BMJ open Vol. 12; no. 9; p. e062525 |
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Main Authors | , , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
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British Medical Journal Publishing Group
28.09.2022
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Abstract | IntroductionPhysical activity (PA) interventions have a promising role in the management of gestational diabetes mellitus (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 motivational interviewing with a bespoke behaviour change informed smartphone application (Stay-Active) to augment PA levels in women with GDM.Methods and analysisThis 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 disseminationThe 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 numberISRCTN11366562. |
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AbstractList | Physical activity (PA) interventions have a promising role in the management of gestational diabetes mellitus (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 motivational interviewing with a bespoke behaviour change informed smartphone application (Stay-Active) to augment PA levels in women with GDM.INTRODUCTIONPhysical activity (PA) interventions have a promising role in the management of gestational diabetes mellitus (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 motivational interviewing with a bespoke behaviour change informed smartphone application (Stay-Active) to augment PA levels in women with GDM.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.METHODS AND ANALYSISThis 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.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.ETHICS AND DISSEMINATIONThe 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.ISRCTN11366562.TRIAL REGISTRATION NUMBERISRCTN11366562. IntroductionPhysical activity (PA) interventions have a promising role in the management of gestational diabetes mellitus (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 motivational interviewing with a bespoke behaviour change informed smartphone application (Stay-Active) to augment PA levels in women with GDM.Methods and analysisThis 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 disseminationThe 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 numberISRCTN11366562. Physical activity (PA) interventions have a promising role in the management of gestational diabetes mellitus (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 motivational interviewing with a bespoke behaviour change informed smartphone application (Stay-Active) to augment PA levels in women with GDM. 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. 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. ISRCTN11366562. Introduction Physical activity (PA) interventions have a promising role in the management of gestational diabetes mellitus (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 motivational interviewing 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. |
Author | Hirst, Jane E Wango, Nicola Michalopoulou, Moscho Dyson, Pamela Roman, Cristian MacKillop, Lucy H Jebb, Susan A Wire, Amy Smith, Ralph Santos, Mauro Pulsford, Richard Tarassenko, Lionel Bateman, Paul Astbury, Nerys M Birks, Jacqueline Kenworthy, Yvonne |
AuthorAffiliation | 2 Oxford Cardiovascular Clinical Research Facility , University of Oxford , Oxford , Oxfordshire , UK 5 Oxford Centre for Diabetes, Endocrinology and Metabolism , University of Oxford , Oxford , UK 7 Women Centre , Oxford University Hospitals NHS Foundation Trust , Oxford , Oxfordshire , UK 3 Nuffield Department of Primary Care Health Sciences , Univeristy of Oxford , Oxford , UK 1 Sport and Exercise Medicine, Rheumatology , Oxford University Hospitals NHS Foundation Trust , Oxford , UK 4 Centre for Statistics in Medicine , University of Oxford , Oxford , UK 9 Institute of Biomedical Engineering, Department of Engineering Science , University of Oxford , Oxford , Oxfordshire , UK 6 Nuffield Department of Women’s and Reproductive Health , University of Oxford , Oxford , UK 10 Patient representative , Oxford University Hospitals NHS Foundation Trust , Oxford , Oxfordshire , UK 8 College of Life and Environmental Sciences , University of Exeter , Exeter , UK |
AuthorAffiliation_xml | – name: 9 Institute of Biomedical Engineering, Department of Engineering Science , University of Oxford , Oxford , Oxfordshire , UK – name: 10 Patient representative , Oxford University Hospitals NHS Foundation Trust , Oxford , Oxfordshire , UK – name: 4 Centre for Statistics in Medicine , University of Oxford , Oxford , UK – name: 8 College of Life and Environmental Sciences , University of Exeter , Exeter , UK – name: 5 Oxford Centre for Diabetes, Endocrinology and Metabolism , University of Oxford , Oxford , UK – name: 6 Nuffield Department of Women’s and Reproductive Health , University of Oxford , Oxford , UK – name: 1 Sport and Exercise Medicine, Rheumatology , Oxford University Hospitals NHS Foundation Trust , Oxford , UK – name: 2 Oxford Cardiovascular Clinical Research Facility , University of Oxford , Oxford , Oxfordshire , UK – name: 3 Nuffield Department of Primary Care Health Sciences , Univeristy of Oxford , Oxford , UK – name: 7 Women Centre , Oxford University Hospitals NHS Foundation Trust , Oxford , Oxfordshire , UK |
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Snippet | IntroductionPhysical activity (PA) interventions have a promising role in the management of gestational diabetes mellitus (GDM). Digital technologies can... Physical activity (PA) interventions have a promising role in the management of gestational diabetes mellitus (GDM). Digital technologies can support PA at... Introduction Physical activity (PA) interventions have a promising role in the management of gestational diabetes mellitus (GDM). Digital technologies can... |
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StartPage | e062525 |
SubjectTerms | Diabetes in pregnancy Diabetes, Gestational - therapy Exercise Feasibility Studies Feedback Female Gestational diabetes Glucose Goal setting Humans Infant, Newborn Information technology Intervention Interviews Maternal medicine Midwifery Mobile Applications Obstetrics and Gynaecology Physical fitness Pregnancy PUBLIC HEALTH Questionnaires Smartphone Smartphones Womens health |
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Title | 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 |
URI | https://bmjopen.bmj.com/content/12/9/e062525.full https://www.ncbi.nlm.nih.gov/pubmed/36171028 https://www.proquest.com/docview/2723721438 https://www.proquest.com/docview/2719420122 https://pubmed.ncbi.nlm.nih.gov/PMC9528591 https://doaj.org/article/b1bb117381fe44c785eae4c6239dc292 |
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