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超重和肥胖女性的产前运动及其对后代和母亲健康的影响:IMPROVE(通过运动改善母婴肥胖)随机对照试验的设计与原理

Antenatal exercise in overweight and obese women and its effects on offspring and maternal health: design and rationale of the IMPROVE (Improving Maternal and Progeny Obesity Via Exercise) randomised controlled trial.

作者信息

Seneviratne Sumudu N, Parry Graham K, McCowan Lesley Me, Ekeroma Alec, Jiang Yannan, Gusso Silmara, Peres Geovana, Rodrigues Raquel O, Craigie Susan, Cutfield Wayne S, Hofman Paul L

机构信息

Liggins Institute, University of Auckland, Auckland, New Zealand.

出版信息

BMC Pregnancy Childbirth. 2014 Apr 26;14:148. doi: 10.1186/1471-2393-14-148.

Abstract

BACKGROUND

Obesity during pregnancy is associated with adverse outcomes for the offspring and mother. Lifestyle interventions in pregnancy such as antenatal exercise, are proposed to improve both short- and long-term health of mother and child. We hypothesise that regular moderate-intensity exercise during the second half of pregnancy will result in improved maternal and offspring outcomes, including a reduction in birth weight and adiposity in the offspring, which may be protective against obesity in later life.

METHODS/DESIGN: The IMPROVE (Improving Maternal and Progeny Risks of Obesity Via Exercise) study is a two-arm parallel randomised controlled clinical trial being conducted in Auckland, New Zealand. Overweight and obese women (BMI ≥25 kg/m2) aged 18-40 years, with a singleton pregnancy of <20 weeks of gestation, from the Auckland region, are eligible for the trial. Exclusion criteria are ongoing smoking or medical contra-indications to antenatal exercise.Participants are randomised with 1:1 allocation ratio to either intervention or control group, using computer-generated randomisation sequences in variable block sizes, stratified on ethnicity and parity, after completion of baseline assessments. The intervention consists of a 16-week structured home-based moderate-intensity exercise programme utilising stationary cycles and heart rate monitors, commencing at 20 weeks of gestation. The control group do not receive any exercise intervention. Both groups undergo regular fetal ultrasonography and receive standard antenatal care. Due to the nature of the intervention, participants are un-blinded to group assignment during the trial.The primary outcome is offspring birth weight. Secondary offspring outcomes include fetal and neonatal body composition and anthropometry, neonatal complications and cord blood metabolic markers. Maternal outcomes include weight gain, pregnancy and delivery complications, aerobic fitness, quality of life, metabolic markers and post-partum body composition.

DISCUSSION

The results of this trial will provide valuable insights on the effects of antenatal exercise on health outcomes in overweight and obese mothers and their offspring.

TRIAL REGISTRATION

Australian New Zealand Clinical Trials Registry ACTRN12612000932864.

摘要

背景

孕期肥胖与后代及母亲的不良结局相关。孕期的生活方式干预,如产前运动,被认为可改善母婴的短期和长期健康状况。我们假设,孕期后半期进行规律的中等强度运动将改善母婴结局,包括降低后代出生体重和肥胖程度,这可能对其成年后的肥胖具有预防作用。

方法/设计:IMPROVE(通过运动改善母婴肥胖风险)研究是在新西兰奥克兰进行的一项双臂平行随机对照临床试验。来自奥克兰地区、年龄在18 - 40岁、单胎妊娠且孕周小于20周的超重及肥胖女性(BMI≥25kg/m²)符合试验条件。排除标准为持续吸烟或存在产前运动的医学禁忌证。在完成基线评估后,采用计算机生成的随机序列,按1:1分配比例,根据种族和产次分层,将参与者随机分为干预组或对照组。干预措施为从妊娠20周开始,进行为期16周的基于家庭的结构化中等强度运动项目,使用固定自行车和心率监测器。对照组不接受任何运动干预。两组均接受定期胎儿超声检查并接受标准的产前护理。由于干预措施的性质,试验期间参与者知晓分组情况。主要结局指标为后代出生体重。次要后代结局指标包括胎儿及新生儿身体组成和人体测量学指标、新生儿并发症及脐血代谢标志物。母亲结局指标包括体重增加、妊娠和分娩并发症、有氧适能、生活质量、代谢标志物及产后身体组成。

讨论

本试验结果将为产前运动对超重及肥胖母亲及其后代健康结局的影响提供有价值的见解。

试验注册号

澳大利亚新西兰临床试验注册中心ACTRN12612000932864。

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