Bump2Baby and Me: protocol for a randomised trial of mHealth coaching for healthy gestational weight gain and improved postnatal outcomes in high-risk women and their children
Abstract Background Gestational diabetes (GDM) impacts 8–18% of pregnancies and greatly increases both maternal and child risk of developing non-communicable diseases such as type 2 diabetes and obesity. Whilst lifestyle interventions in pregnancy and postpartum reduce this risk, a research translat...
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| Format: | Article |
| Language: | English |
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BMC
2021-12-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-021-05892-4 |
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| author | Sharleen L. O’Reilly Christy Burden Cristina Campoy Fionnuala M. McAuliffe Helena Teede Jesper Andresen Karen J. Campbell Aisling A. Geraghty Cheryce L. Harrison Rachel Laws Jane E. Norman Helle T. Maindal Karsten Vrangbæk Ricardo Segurado Vincent L. Versace Timothy C. Skinner on behalf of the IMPACT DIABETES B2B Collaboration Group |
| author_facet | Sharleen L. O’Reilly Christy Burden Cristina Campoy Fionnuala M. McAuliffe Helena Teede Jesper Andresen Karen J. Campbell Aisling A. Geraghty Cheryce L. Harrison Rachel Laws Jane E. Norman Helle T. Maindal Karsten Vrangbæk Ricardo Segurado Vincent L. Versace Timothy C. Skinner on behalf of the IMPACT DIABETES B2B Collaboration Group |
| author_sort | Sharleen L. O’Reilly |
| collection | DOAJ |
| description | Abstract Background Gestational diabetes (GDM) impacts 8–18% of pregnancies and greatly increases both maternal and child risk of developing non-communicable diseases such as type 2 diabetes and obesity. Whilst lifestyle interventions in pregnancy and postpartum reduce this risk, a research translation gap remains around delivering implementable interventions with adequate population penetration and participation. Impact Diabetes Bump2Baby is an implementation project of an evidence-based system of care for the prevention of overweight and obesity. Bump2Baby and Me is the multicentre randomised controlled trial investigating the effectiveness of a mHealth coaching programme in pregnancy and postpartum for women at high risk of developing GDM. Methods Eight hundred women will be recruited in early pregnancy from 4 clinical sites within Ireland, the UK, Spain, and Australia. Women will be screened for eligibility using the validated Monash GDM screening tool. Participants will be enrolled from 12 to 24 weeks’ gestation and randomised on a 1:1 basis into the intervention or control arm. Alongside usual care, the intervention involves mHealth coaching via a smartphone application, which uses a combination of synchronous and asynchronous video and text messaging, and allows for personalised support and goal setting with a trained health coach. The control arm receives usual care. All women and their children will be followed from early pregnancy until 12 months postpartum. The primary outcome will be a difference in maternal body mass index (BMI) of 0.8 kg/m2 at 12 months postpartum. Secondary maternal and infant outcomes include the development of GDM, gestational weight gain, pregnancy outcomes, improvements in diet, physical activity, sleep, and neonatal weight and infant growth patterns. The 5-year project is funded by the EU Commission Horizon 2020 and the Australian National Health and Medical Research Council. Ethical approval has been received. Discussion Previous interventions have not moved beyond tightly controlled efficacy trials into routine service delivery. This project aims to provide evidence-based, sustainable support that could be incorporated into usual care for women during pregnancy and postpartum. This study will contribute evidence to inform the early prevention of non-communicable diseases like obesity and diabetes in mothers and the next generation. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12620001240932 . Registered on 19 November 2020 |
| first_indexed | 2024-12-18T04:12:58Z |
| format | Article |
| id | doaj.art-1fffcb59f34b4ae182362890bdf44bd1 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-18T04:12:58Z |
| publishDate | 2021-12-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-1fffcb59f34b4ae182362890bdf44bd12022-12-21T21:21:25ZengBMCTrials1745-62152021-12-0122111510.1186/s13063-021-05892-4Bump2Baby and Me: protocol for a randomised trial of mHealth coaching for healthy gestational weight gain and improved postnatal outcomes in high-risk women and their childrenSharleen L. O’Reilly0Christy Burden1Cristina Campoy2Fionnuala M. McAuliffe3Helena Teede4Jesper Andresen5Karen J. Campbell6Aisling A. Geraghty7Cheryce L. Harrison8Rachel Laws9Jane E. Norman10Helle T. Maindal11Karsten Vrangbæk12Ricardo Segurado13Vincent L. Versace14Timothy C. Skinner15on behalf of the IMPACT DIABETES B2B Collaboration GroupSchool of Agriculture and Food Science, University College DublinFaculty of Health Sciences, University of BristolDepartment of Paediatrics, School of Medicine, University of GranadaUCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity HospitalMonash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, ClaytonLIVA HealthcareInstitute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University GeelongSchool of Agriculture and Food Science, University College DublinMonash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, ClaytonInstitute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University GeelongFaculty of Health Sciences, University of BristolDepartment of Public Health, Section for Health Promotion and Health Services, Aarhus UniversityDepartment of Public Health, Center for Health Economics and Policy, University of CopenhagenSchool of Public Health, Physiotherapy, and Sports Science, University College DublinDeakin Rural Health, School of Medicine, Faculty of Health, Deakin UniversityInstitut for Psykologi, Center for Sundhed of Samfund, Københavns UniversitetAbstract Background Gestational diabetes (GDM) impacts 8–18% of pregnancies and greatly increases both maternal and child risk of developing non-communicable diseases such as type 2 diabetes and obesity. Whilst lifestyle interventions in pregnancy and postpartum reduce this risk, a research translation gap remains around delivering implementable interventions with adequate population penetration and participation. Impact Diabetes Bump2Baby is an implementation project of an evidence-based system of care for the prevention of overweight and obesity. Bump2Baby and Me is the multicentre randomised controlled trial investigating the effectiveness of a mHealth coaching programme in pregnancy and postpartum for women at high risk of developing GDM. Methods Eight hundred women will be recruited in early pregnancy from 4 clinical sites within Ireland, the UK, Spain, and Australia. Women will be screened for eligibility using the validated Monash GDM screening tool. Participants will be enrolled from 12 to 24 weeks’ gestation and randomised on a 1:1 basis into the intervention or control arm. Alongside usual care, the intervention involves mHealth coaching via a smartphone application, which uses a combination of synchronous and asynchronous video and text messaging, and allows for personalised support and goal setting with a trained health coach. The control arm receives usual care. All women and their children will be followed from early pregnancy until 12 months postpartum. The primary outcome will be a difference in maternal body mass index (BMI) of 0.8 kg/m2 at 12 months postpartum. Secondary maternal and infant outcomes include the development of GDM, gestational weight gain, pregnancy outcomes, improvements in diet, physical activity, sleep, and neonatal weight and infant growth patterns. The 5-year project is funded by the EU Commission Horizon 2020 and the Australian National Health and Medical Research Council. Ethical approval has been received. Discussion Previous interventions have not moved beyond tightly controlled efficacy trials into routine service delivery. This project aims to provide evidence-based, sustainable support that could be incorporated into usual care for women during pregnancy and postpartum. This study will contribute evidence to inform the early prevention of non-communicable diseases like obesity and diabetes in mothers and the next generation. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12620001240932 . Registered on 19 November 2020https://doi.org/10.1186/s13063-021-05892-4PregnancyGestational diabetesObesitymHealthImplementationPostpartum |
| spellingShingle | Sharleen L. O’Reilly Christy Burden Cristina Campoy Fionnuala M. McAuliffe Helena Teede Jesper Andresen Karen J. Campbell Aisling A. Geraghty Cheryce L. Harrison Rachel Laws Jane E. Norman Helle T. Maindal Karsten Vrangbæk Ricardo Segurado Vincent L. Versace Timothy C. Skinner on behalf of the IMPACT DIABETES B2B Collaboration Group Bump2Baby and Me: protocol for a randomised trial of mHealth coaching for healthy gestational weight gain and improved postnatal outcomes in high-risk women and their children Trials Pregnancy Gestational diabetes Obesity mHealth Implementation Postpartum |
| title | Bump2Baby and Me: protocol for a randomised trial of mHealth coaching for healthy gestational weight gain and improved postnatal outcomes in high-risk women and their children |
| title_full | Bump2Baby and Me: protocol for a randomised trial of mHealth coaching for healthy gestational weight gain and improved postnatal outcomes in high-risk women and their children |
| title_fullStr | Bump2Baby and Me: protocol for a randomised trial of mHealth coaching for healthy gestational weight gain and improved postnatal outcomes in high-risk women and their children |
| title_full_unstemmed | Bump2Baby and Me: protocol for a randomised trial of mHealth coaching for healthy gestational weight gain and improved postnatal outcomes in high-risk women and their children |
| title_short | Bump2Baby and Me: protocol for a randomised trial of mHealth coaching for healthy gestational weight gain and improved postnatal outcomes in high-risk women and their children |
| title_sort | bump2baby and me protocol for a randomised trial of mhealth coaching for healthy gestational weight gain and improved postnatal outcomes in high risk women and their children |
| topic | Pregnancy Gestational diabetes Obesity mHealth Implementation Postpartum |
| url | https://doi.org/10.1186/s13063-021-05892-4 |
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