Women, their Offspring and iMproving lifestyle for Better cardiovascular health of both (WOMB project): A protocol of the follow-up of a multicentre randomised controlled trial

Cornelieke Van De Beek; Annemieke Hoek; Rebecca C. Painter; Reinoud J.B.J. Gemke; Mireille N.M. Van Poppel; Anouk Geelen; Henk Groen; Ben Willem Mol; Tessa J. Roseboom

doi:10.1136/bmjopen-2017-016579

Women, their Offspring and iMproving lifestyle for Better cardiovascular health of both (WOMB project): A protocol of the follow-up of a multicentre randomised controlled trial

Cornelieke Van De Beek^* (Corresponding Author), Annemieke Hoek, Rebecca C. Painter, Reinoud J.B.J. Gemke, Mireille N.M. Van Poppel, Anouk Geelen, Henk Groen, Ben Willem Mol, Tessa J. Roseboom

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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Abstract

Introduction Women, their Offspring and iMproving lifestyle for Better cardiovascular health of both (WOMB) project is the follow-up of the LIFEstyle study, a randomised controlled trial in obese infertile women, and investigates the effects of a preconception lifestyle intervention on later health of women (WOMB women) and their children (WOMB kids). Methods and analysis Obese infertile women, aged between 18 and 39 years, were recruited in 23 Dutch fertility clinics between June 2009 and June 2012. The 284 women allocated to the intervention group received a 6-month structured lifestyle programme. The 280 women in the control group received infertility care as usual. 4 to 7 years after inclusion in the trial, all women (n=564) and children conceived during the trial (24 months after randomisation) (n=305 singletons and age 3-5 years) will be approached to participate in this follow-up study (starting in 2015). The main focus of outcome will be cardiovascular health, but the dataset comprises a wide range of physical and mental health measures, diet and physical activity measures, child growth and development measures, biological samples and genetic and epigenetic information. The follow-up assessment consists of three stages that take place between 2016 and 2018, and includes (online) questionnaires, accelerometry and physical and behavioural measurements in a mobile research vehicle. A subsample of 100 women and 100 children are planned for cardiac ultrasound measurements. Ethics and dissemination The protocol of this follow-up study is approved by the local medical ethics committee (University Medical Centre Groningen). Study findings of the WOMB project will be widely disseminated to the scientific community, healthcare professionals, policy makers, future parents and general public. Trial registration number The original LIFEstyle study is registered at The Netherlands Trial Registry (number 1530).

Original language	English
Article number	e016579
Pages (from-to)	1-8
Number of pages	8
Journal	BMJ Open
Volume	8
Issue number	1
Early online date	24 Jan 2018
DOIs	https://doi.org/10.1136/bmjopen-2017-016579
Publication status	Published - Jan 2018

Bibliographical note

The LIFEstyle study was supported by a grant from The Netherlands Organization for Health Research and Development (50-50110-96-518). The WOMB project is funded by the Dutch Heart Foundation (2013T085) and the European Commission (Horizon2020 project ‘DynaHealth’, 633595).

Data Availability Statement

The WOMBproject group is open to collaboration: in case
of data requests, additional analyses or collaborative studies, please contact the WOMB project coordinator(t.j.roseboom@amc.uva.nl).

Keywords

maternal medicine
preventive medicine
reproductive medicine

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Cite this

Van De Beek, C., Hoek, A., Painter, R. C., Gemke, R. J. B. J., Van Poppel, M. N. M., Geelen, A., Groen, H., Willem Mol, B., & Roseboom, T. J. (2018). Women, their Offspring and iMproving lifestyle for Better cardiovascular health of both (WOMB project): A protocol of the follow-up of a multicentre randomised controlled trial. BMJ Open, 8(1), 1-8. Article e016579. https://doi.org/10.1136/bmjopen-2017-016579

Women, their Offspring and iMproving lifestyle for Better cardiovascular health of both (WOMB project): A protocol of the follow-up of a multicentre randomised controlled trial. / Van De Beek, Cornelieke (Corresponding Author); Hoek, Annemieke; Painter, Rebecca C. et al.
In: BMJ Open, Vol. 8, No. 1, e016579, 01.2018, p. 1-8.

Research output: Contribution to journal › Article › peer-review

Van De Beek, C, Hoek, A, Painter, RC, Gemke, RJBJ, Van Poppel, MNM, Geelen, A, Groen, H, Willem Mol, B & Roseboom, TJ 2018, 'Women, their Offspring and iMproving lifestyle for Better cardiovascular health of both (WOMB project): A protocol of the follow-up of a multicentre randomised controlled trial', BMJ Open, vol. 8, no. 1, e016579, pp. 1-8. https://doi.org/10.1136/bmjopen-2017-016579

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abstract = "Introduction Women, their Offspring and iMproving lifestyle for Better cardiovascular health of both (WOMB) project is the follow-up of the LIFEstyle study, a randomised controlled trial in obese infertile women, and investigates the effects of a preconception lifestyle intervention on later health of women (WOMB women) and their children (WOMB kids). Methods and analysis Obese infertile women, aged between 18 and 39 years, were recruited in 23 Dutch fertility clinics between June 2009 and June 2012. The 284 women allocated to the intervention group received a 6-month structured lifestyle programme. The 280 women in the control group received infertility care as usual. 4 to 7 years after inclusion in the trial, all women (n=564) and children conceived during the trial (24 months after randomisation) (n=305 singletons and age 3-5 years) will be approached to participate in this follow-up study (starting in 2015). The main focus of outcome will be cardiovascular health, but the dataset comprises a wide range of physical and mental health measures, diet and physical activity measures, child growth and development measures, biological samples and genetic and epigenetic information. The follow-up assessment consists of three stages that take place between 2016 and 2018, and includes (online) questionnaires, accelerometry and physical and behavioural measurements in a mobile research vehicle. A subsample of 100 women and 100 children are planned for cardiac ultrasound measurements. Ethics and dissemination The protocol of this follow-up study is approved by the local medical ethics committee (University Medical Centre Groningen). Study findings of the WOMB project will be widely disseminated to the scientific community, healthcare professionals, policy makers, future parents and general public. Trial registration number The original LIFEstyle study is registered at The Netherlands Trial Registry (number 1530).",

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N2 - Introduction Women, their Offspring and iMproving lifestyle for Better cardiovascular health of both (WOMB) project is the follow-up of the LIFEstyle study, a randomised controlled trial in obese infertile women, and investigates the effects of a preconception lifestyle intervention on later health of women (WOMB women) and their children (WOMB kids). Methods and analysis Obese infertile women, aged between 18 and 39 years, were recruited in 23 Dutch fertility clinics between June 2009 and June 2012. The 284 women allocated to the intervention group received a 6-month structured lifestyle programme. The 280 women in the control group received infertility care as usual. 4 to 7 years after inclusion in the trial, all women (n=564) and children conceived during the trial (24 months after randomisation) (n=305 singletons and age 3-5 years) will be approached to participate in this follow-up study (starting in 2015). The main focus of outcome will be cardiovascular health, but the dataset comprises a wide range of physical and mental health measures, diet and physical activity measures, child growth and development measures, biological samples and genetic and epigenetic information. The follow-up assessment consists of three stages that take place between 2016 and 2018, and includes (online) questionnaires, accelerometry and physical and behavioural measurements in a mobile research vehicle. A subsample of 100 women and 100 children are planned for cardiac ultrasound measurements. Ethics and dissemination The protocol of this follow-up study is approved by the local medical ethics committee (University Medical Centre Groningen). Study findings of the WOMB project will be widely disseminated to the scientific community, healthcare professionals, policy makers, future parents and general public. Trial registration number The original LIFEstyle study is registered at The Netherlands Trial Registry (number 1530).

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Women, their Offspring and iMproving lifestyle for Better cardiovascular health of both (WOMB project): A protocol of the follow-up of a multicentre randomised controlled trial

Abstract

Bibliographical note

Data Availability Statement

Keywords

UN SDGs

Access to Document

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Cite this