女性、其后代与改善生活方式以促进双方心血管健康（WOMB项目）：一项多中心随机对照试验的随访方案
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.
作者信息
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
机构信息
Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, The Netherlands.
Department of Obstetrics and Gynaecology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.
出版信息
BMJ Open. 2018 Jan 24;8(1):e016579. doi: 10.1136/bmjopen-2017-016579.
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).
引言
女性、其后代与改善生活方式以促进双方更好的心血管健康（WOMB）项目是生活方式研究的后续研究，生活方式研究是一项针对肥胖不孕女性的随机对照试验，该项目旨在调查孕前生活方式干预对女性（WOMB女性）及其子女（WOMB儿童）后期健康的影响。
方法与分析
2009年6月至2012年6月期间，在荷兰23家生育诊所招募了年龄在18至39岁之间的肥胖不孕女性。分配到干预组的284名女性接受了为期6个月的结构化生活方式计划。对照组的280名女性接受常规不孕治疗。在纳入试验4至7年后，将邀请所有女性（n = 564）以及在试验期间受孕的儿童（随机分组24个月后）（n = 305名单胎且年龄为3至5岁）参与这项后续研究（从2015年开始）。结果的主要重点将是心血管健康，但数据集包括广泛的身心健康指标、饮食和身体活动指标、儿童生长发育指标、生物样本以及基因和表观遗传信息。后续评估包括2016年至2018年期间的三个阶段，包括（在线）问卷调查、加速度计测量以及在移动研究车辆中进行的身体和行为测量。计划对100名女性和100名儿童的子样本进行心脏超声测量。
伦理与传播
这项后续研究的方案已获得当地医学伦理委员会（格罗宁根大学医学中心）的批准。WOMB项目的研究结果将广泛传播给科学界、医疗保健专业人员、政策制定者、准父母和公众。
试验注册号
最初的生活方式研究已在荷兰试验注册中心注册（编号1530）。
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