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 inBMJ open Vol. 12; no. 9; p. e062525
Main Authors Smith, Ralph, Kenworthy, Yvonne, Astbury, Nerys M, Birks, Jacqueline, Bateman, Paul, Dyson, Pamela, Hirst, Jane E, Jebb, Susan A, Michalopoulou, Moscho, Pulsford, Richard, Roman, Cristian, Santos, Mauro, Tarassenko, Lionel, Wango, Nicola, Wire, Amy, MacKillop, Lucy H
Format Journal Article
LanguageEnglish
Published England 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.
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
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BackLink https://www.ncbi.nlm.nih.gov/pubmed/36171028$$D View this record in MEDLINE/PubMed
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Issue 9
Keywords PUBLIC HEALTH
Diabetes in pregnancy
Information technology
Maternal medicine
Language English
License This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
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  ident: 2022112903201307000_12.9.e062525.1
  article-title: The world Health organization (who) versus the International association of diabetes and pregnancy Study Group (IADPSG) diagnostic criteria of gestational diabetes mellitus (GDM) and their associated maternal and neonatal outcomes
  publication-title: Horm Mol Biol Clin Investig
– ident: 2022112903201307000_12.9.e062525.32
  doi: 10.1249/MSS.0000000000000289
– ident: 2022112903201307000_12.9.e062525.2
  doi: 10.1056/NEJMoa0707943
– ident: 2022112903201307000_12.9.e062525.35
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– ident: 2022112903201307000_12.9.e062525.34
  doi: 10.1136/bjsports-2018-100056
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  doi: 10.1186/s12966-016-0454-y
– ident: 2022112903201307000_12.9.e062525.28
  doi: 10.1177/1932296814556506
– volume: 8
  start-page: CD012327
  year: 2018
  ident: 2022112903201307000_12.9.e062525.7
  article-title: Treatments for women with gestational diabetes mellitus: an overview of Cochrane systematic reviews
  publication-title: Cochrane Database Syst Rev
– ident: 2022112903201307000_12.9.e062525.40
  doi: 10.1016/j.pec.2008.11.002
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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
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https://pubmed.ncbi.nlm.nih.gov/PMC9528591
https://doaj.org/article/b1bb117381fe44c785eae4c6239dc292
Volume 12
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