A complex intervention to improve pregnancy outcome in obese women; the UPBEAT randomised controlled trial.

A complex intervention to improve pregnancy outcome in obese women; the UPBEAT randomised controlled trial.
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DOI:
10.1186/1471-2393-14-74
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发表时间:
2014-02-18
影响因子:
3.1
通讯作者:
Poston L
Poston L
中科院分区:
医学3区
文献类型:
--
作者:
Briley AL;Barr S;Badger S;Bell R;Croker H;Godfrey KM;Holmes B;Kinnunen TI;Nelson SM;Oteng-Ntim E;Patel N;Robson SC;Sandall J;Sanders T;Sattar N;Seed PT;Wardle J;Poston L

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尽管人们普遍认识到孕妇肥胖与母亲和儿童的不良后果有关,但没有任何干预措施可以降低这些并发症的风险。这项随机对照试验的主要目的是评估肥胖孕妇,基于改变饮食(血糖指数较低的食物)和体力活动的复杂行为干预是否会降低妊娠期糖尿病(GDM)和分娩大于胎龄(LGA)婴儿的风险。第二个目的是确定干预是否降低了后代肥胖的长期风险。一项多中心随机对照试验,旨在比较肥胖孕妇的行为干预与标准产前护理,以改善血糖控制。入选标准:BMI ≥30 kg/m2且妊娠15+0周至18+6周的单胎妊娠女性。排除标准:预先定义的,预先存在的疾病和多胎妊娠。随机化通过计算机生成的程序在线进行,并根据BMI类别、母亲年龄、种族、产次和中心进行最小化。干预;这是由一名健康培训师在8次会议上提供的。以控制理论为基础,结合社会认知理论的要素,设计干预措施以改善产妇血糖控制。随机分配至对照组的女性根据当地指南接受标准产前护理直至分娩。所有妇女在妊娠27+0- 28+6周时进行75 g口服葡萄糖耐量试验。主要结局:母亲:根据国际妊娠期糖尿病协会研究组(IADPSG)标准诊断为GDM。新生儿;婴儿LGA定义为>第90个定制出生体重百分位数。样本量; 1546名妇女提供80%的把握度,以检测GDM发病率降低25%,大于胎龄儿减少30%。该方案的所有方面都已在一项初步随机对照试验中进行了评估,随后对干预措施进行了优化。这项试验的结果将告知肥胖孕妇的生活方式介导的血糖控制改善是否可以最大限度地降低妊娠并发症的风险。当前对照试验; ISRCTN 89971375。
Despite the widespread recognition that obesity in pregnant women is associated with adverse outcomes for mother and child, there is no intervention proven to reduce the risk of these complications. The primary aim of this randomised controlled trial is to assess in obese pregnant women, whether a complex behavioural intervention, based on changing diet (to foods with a lower glycemic index) and physical activity, will reduce the risk of gestational diabetes (GDM) and delivery of a large for gestational age (LGA) infant. A secondary aim is to determine whether the intervention lowers the long term risk of obesity in the offspring. Multicentre randomised controlled trial comparing a behavioural intervention designed to improve glycemic control with standard antenatal care in obese pregnant women. Inclusion criteria; women with a BMI ≥30 kg/m2 and a singleton pregnancy between 15+0 weeks and 18+6 weeks’ gestation. Exclusion criteria; pre-defined, pre-existing diseases and multiple pregnancy. Randomisation is on-line by a computer generated programme and is minimised by BMI category, maternal age, ethnicity, parity and centre. Intervention; this is delivered by a health trainer over 8 sessions. Based on control theory, with elements of social cognitive theory, the intervention is designed to improve maternal glycemic control. Women randomised to the control arm receive standard antenatal care until delivery according to local guidelines. All women have a 75 g oral glucose tolerance test at 27+0- 28+6 weeks’ gestation. Primary outcome; Maternal: diagnosis of GDM, according to the International Association of Diabetes in Pregnancy Study Group (IADPSG) criteria. Neonatal; infant LGA defined as >90th customised birth weight centile. Sample size; 1546 women to provide 80% power to detect a 25% reduction in the incidence of GDM and a 30% reduction in infants large for gestational age. All aspects of this protocol have been evaluated in a pilot randomised controlled trial, with subsequent optimisation of the intervention. The findings of this trial will inform whether lifestyle mediated improvement of glycemic control in obese pregnant women can minimise the risk of pregnancy complications. Current controlled trials; ISRCTN89971375.
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发表时间: 2011-10
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