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

Research output: Contribution to journalArticleAcademicpeer-review

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 languageEnglish
Article numbere016579
JournalBMJ Open
Volume8
Issue number1
DOIs
Publication statusPublished - 2018

Cite this

@article{0a692893f04945c4a38dc1c18bd275b4,
title = "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 = "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).",
author = "{van de Beek}, Cornelieke and Annemieke Hoek and Painter, {Rebecca C.} and Gemke, {Reinoud J. B. J.} and {van Poppel}, {Mireille N. M.} and Anouk Geelen and Henk Groen and {Willem Mol}, Ben and Roseboom, {Tessa J.}",
year = "2018",
doi = "10.1136/bmjopen-2017-016579",
language = "English",
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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. / van de Beek, Cornelieke; Hoek, Annemieke; Painter, Rebecca C.; Gemke, Reinoud J. B. J.; van Poppel, Mireille N. M.; Geelen, Anouk; Groen, Henk; Willem Mol, Ben; Roseboom, Tessa J.

In: BMJ Open, Vol. 8, No. 1, e016579, 2018.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - 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

AU - van de Beek, Cornelieke

AU - Hoek, Annemieke

AU - Painter, Rebecca C.

AU - Gemke, Reinoud J. B. J.

AU - van Poppel, Mireille N. M.

AU - Geelen, Anouk

AU - Groen, Henk

AU - Willem Mol, Ben

AU - Roseboom, Tessa J.

PY - 2018

Y1 - 2018

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).

AB - 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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UR - https://www.ncbi.nlm.nih.gov/pubmed/29371262

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