Effectiveness of a mobile preconception lifestyle programme in couples undergoing in vitro fertilisation (IVF): the protocol for the PreLiFe randomised controlled trial (PreLiFe-RCT)
Introduction Infertility and in vitro fertilisation (IVF; with or without intracytoplasmic sperm injection) result in considerable emotional and financial burden. Increasing evidence suggests that lifestyle factors, including diet, physical activity and personal well-being, are associated with IVF-s...
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BMJ Publishing Group
2019-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/7/e029665.full |
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| author | Tessy Boedt Eline Dancet Sharon Lie Fong Karen Peeraer Diane De Neubourg Sofie Pelckmans Arne van de Vijver Jan Seghers Katleen Van der Gucht Ben Van Calster Carl Spiessens Christophe Matthys |
| author_facet | Tessy Boedt Eline Dancet Sharon Lie Fong Karen Peeraer Diane De Neubourg Sofie Pelckmans Arne van de Vijver Jan Seghers Katleen Van der Gucht Ben Van Calster Carl Spiessens Christophe Matthys |
| author_sort | Tessy Boedt |
| collection | DOAJ |
| description | Introduction Infertility and in vitro fertilisation (IVF; with or without intracytoplasmic sperm injection) result in considerable emotional and financial burden. Increasing evidence suggests that lifestyle factors, including diet, physical activity and personal well-being, are associated with IVF-success rates. Currently, IVF is not routinely combined with a lifestyle programme. The preconception lifestyle (PreLiFe) randomised controlled trial (RCT) assesses the effects of a new mobile PreLiFe programme in couples undergoing IVF.Methods and analysis A multicentre RCT including 460 heterosexual couples starting IVF in Belgian fertility clinics. IVF couples are randomised between an attention control group or the PreLiFe programme for a period of 12 months or until an ongoing pregnancy is confirmed by ultrasound. The attention control programme includes a mobile application with treatment information (ie, appointments and medication instructions) in addition to standard care. The PreLiFe programme includes a mobile application with the same treatment information in combination with a lifestyle programme. This new lifestyle programme includes tailored advice and skills training on diet, physical activity and mindfulness in combination with text messages and telephone interaction with a healthcare professional trained in motivational interviewing. The primary outcome of this RCT is the cumulative ongoing pregnancy rate within 12 months after randomisation. Secondary outcomes include changes in diet, physical activity, emotional distress, body mass index, waist circumference, quality of life and other reproductive outcomes including IVF discontinuation, clinical pregnancy rate and time to pregnancy. Additionally, partner support and the feasibility (use and acceptability) of the PreLiFe programme will be evaluated in the intervention group. Analysis will be according to intention to treat.Ethics and dissemination This study has been approved by the Medical Ethical Committee of the Leuven University Hospital (Belgium) and the other recruiting clinics. The findings of this RCT will be disseminated through presentations at international scientific meetings and peer-reviewed publications.Trial registration number NCT03790449; Pre-results. |
| format | Article |
| id | doaj-art-ac121f6f52b7475baae540b70fdd6ce8 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-ac121f6f52b7475baae540b70fdd6ce82025-08-20T02:07:12ZengBMJ Publishing GroupBMJ Open2044-60552019-07-019710.1136/bmjopen-2019-029665Effectiveness of a mobile preconception lifestyle programme in couples undergoing in vitro fertilisation (IVF): the protocol for the PreLiFe randomised controlled trial (PreLiFe-RCT)Tessy Boedt0Eline Dancet1Sharon Lie Fong2Karen Peeraer3Diane De Neubourg4Sofie Pelckmans5Arne van de Vijver6Jan Seghers7Katleen Van der Gucht8Ben Van Calster9Carl Spiessens10Christophe Matthys11Leuven Mindfulness Centre, KU Leuven, Leuven, BelgiumLeuven University Fertility Centre, Katholieke Universiteit Leuven UZ Leuven, Leuven, Belgium2 Leuven University Fertility Centre, University Hospitals Leuven, Leuven, BelgiumLeuven University Fertility Centre, University Hospital Leuven, Leuven, BelgiumCentre for Reproductive Medicine, Antwerp University Hospital, Edegem, Belgium5 Department of Obstetrics and Gynaecology, Imelda Hospital Bonheiden, Bonheiden, Belgium6 Department of Obstetrics and Gynaecology, General Hospital Sint Jan Bruges-Ostend, Brugge, Belgium7 Department of Movement Sciences, KU Leuven, Leuven, BelgiumLeuven Mindfulness Centre, KU Leuven, Leuven, BelgiumDepartment of Biomedical Data Sciences, Leiden University Medical Centre, Leiden, NetherlandsDepartment of Development and Regeneration, KU Leuven, Leuven, BelgiumDepartment of Chronic Diseases and Metabolism, KU Leuven, Leuven, BelgiumIntroduction Infertility and in vitro fertilisation (IVF; with or without intracytoplasmic sperm injection) result in considerable emotional and financial burden. Increasing evidence suggests that lifestyle factors, including diet, physical activity and personal well-being, are associated with IVF-success rates. Currently, IVF is not routinely combined with a lifestyle programme. The preconception lifestyle (PreLiFe) randomised controlled trial (RCT) assesses the effects of a new mobile PreLiFe programme in couples undergoing IVF.Methods and analysis A multicentre RCT including 460 heterosexual couples starting IVF in Belgian fertility clinics. IVF couples are randomised between an attention control group or the PreLiFe programme for a period of 12 months or until an ongoing pregnancy is confirmed by ultrasound. The attention control programme includes a mobile application with treatment information (ie, appointments and medication instructions) in addition to standard care. The PreLiFe programme includes a mobile application with the same treatment information in combination with a lifestyle programme. This new lifestyle programme includes tailored advice and skills training on diet, physical activity and mindfulness in combination with text messages and telephone interaction with a healthcare professional trained in motivational interviewing. The primary outcome of this RCT is the cumulative ongoing pregnancy rate within 12 months after randomisation. Secondary outcomes include changes in diet, physical activity, emotional distress, body mass index, waist circumference, quality of life and other reproductive outcomes including IVF discontinuation, clinical pregnancy rate and time to pregnancy. Additionally, partner support and the feasibility (use and acceptability) of the PreLiFe programme will be evaluated in the intervention group. Analysis will be according to intention to treat.Ethics and dissemination This study has been approved by the Medical Ethical Committee of the Leuven University Hospital (Belgium) and the other recruiting clinics. The findings of this RCT will be disseminated through presentations at international scientific meetings and peer-reviewed publications.Trial registration number NCT03790449; Pre-results.https://bmjopen.bmj.com/content/9/7/e029665.full |
| spellingShingle | Tessy Boedt Eline Dancet Sharon Lie Fong Karen Peeraer Diane De Neubourg Sofie Pelckmans Arne van de Vijver Jan Seghers Katleen Van der Gucht Ben Van Calster Carl Spiessens Christophe Matthys Effectiveness of a mobile preconception lifestyle programme in couples undergoing in vitro fertilisation (IVF): the protocol for the PreLiFe randomised controlled trial (PreLiFe-RCT) BMJ Open |
| title | Effectiveness of a mobile preconception lifestyle programme in couples undergoing in vitro fertilisation (IVF): the protocol for the PreLiFe randomised controlled trial (PreLiFe-RCT) |
| title_full | Effectiveness of a mobile preconception lifestyle programme in couples undergoing in vitro fertilisation (IVF): the protocol for the PreLiFe randomised controlled trial (PreLiFe-RCT) |
| title_fullStr | Effectiveness of a mobile preconception lifestyle programme in couples undergoing in vitro fertilisation (IVF): the protocol for the PreLiFe randomised controlled trial (PreLiFe-RCT) |
| title_full_unstemmed | Effectiveness of a mobile preconception lifestyle programme in couples undergoing in vitro fertilisation (IVF): the protocol for the PreLiFe randomised controlled trial (PreLiFe-RCT) |
| title_short | Effectiveness of a mobile preconception lifestyle programme in couples undergoing in vitro fertilisation (IVF): the protocol for the PreLiFe randomised controlled trial (PreLiFe-RCT) |
| title_sort | effectiveness of a mobile preconception lifestyle programme in couples undergoing in vitro fertilisation ivf the protocol for the prelife randomised controlled trial prelife rct |
| url | https://bmjopen.bmj.com/content/9/7/e029665.full |
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