Discipline of Obstetrics and Gynaecology, School of Paediatrics and Reproductive Health, The University of Adelaide, Adelaide, Australia.
BMC Pregnancy Childbirth. 2011 Oct 26;11:79. doi: 10.1186/1471-2393-11-79.
Obesity is a significant global health problem, with the proportion of women entering pregnancy with a body mass index greater than or equal to 25 kg/m2 approaching 50%. Obesity during pregnancy is associated with a well-recognised increased risk of adverse health outcomes both for the woman and her infant, however there is more limited information available regarding effective interventions to improve health outcomes.The aims of this randomised controlled trial are to assess whether the implementation of a package of dietary and lifestyle advice to overweight and obese women during pregnancy to limit gestational weight gain is effective in improving maternal, fetal and infant health outcomes.
Multicentred randomised, controlled trial.
Women with a singleton, live gestation between 10(+0)-20(+0) weeks who are obese or overweight (defined as body mass index greater than or equal to 25 kg/m2), at the first antenatal visit. Trial Entry & Randomisation: Eligible, consenting women will be randomised between 10(+0) and 20(+0) weeks gestation using a central telephone randomisation service, and randomisation schedule prepared by non-clinical research staff with balanced variable blocks. Stratification will be according to maternal BMI at trial entry, parity, and centre where planned to give birth. Treatment Schedules: Women randomised to the Dietary and Lifestyle Advice Group will receive a series of inputs from research assistants and research dietician to limit gestational weight gain, and will include a combination of dietary, exercise and behavioural strategies. Women randomised to the Standard Care Group will continue to receive their pregnancy care according to local hospital guidelines, which does not currently include routine provision of dietary, lifestyle and behavioural advice. Outcome assessors will be blinded to the allocated treatment group. Primary Study Outcome: infant large for gestational age (defined as infant birth weight ≥ 90th centile for gestational age).
2,180 women to detect a 30% reduction in large for gestational age infants from 14.40% (p = 0.05, 80% power, two-tailed).
This is a protocol for a randomised trial. The findings will contribute to the development of evidence based clinical practice guidelines.
Australian and New Zealand Clinical Trials Registry ACTRN12607000161426.
肥胖是一个全球性的重大健康问题，有 50%的女性在怀孕时的体重指数（BMI）大于或等于 25kg/m2。怀孕期间肥胖与母婴健康不良结局的风险增加密切相关，但对于改善健康结局的有效干预措施的信息则更为有限。本随机对照试验的目的是评估在妊娠期间向超重和肥胖女性提供饮食和生活方式建议以限制孕期体重增加的综合方案是否能有效改善母婴健康结局。
多中心随机对照试验。
孕 10 周（+0）至 20 周（+0）单胎、活胎，超重或肥胖（定义为 BMI 大于或等于 25kg/m2）的初产妇。
符合条件且同意参加的孕妇将在 10 周（+0）至 20 周（+0）妊娠期间通过中央电话随机分组服务进行随机分组，由非临床研究人员根据平衡的变量块准备随机分组方案。分层因素为试验开始时的母体 BMI、产次和分娩计划地点。
随机分组至饮食和生活方式建议组的女性将接受一系列由研究助理和研究营养师提供的输入，以限制孕期体重增加，其中包括饮食、运动和行为策略的组合。随机分组至标准护理组的女性将继续根据当地医院指南接受妊娠护理，目前不包括常规提供饮食、生活方式和行为建议。结局评估人员将对分配的治疗组进行盲法。
婴儿大于胎龄（定义为婴儿出生体重≥按胎龄计算的第 90 百分位数）。
2180 名女性，以检测出巨大儿（出生体重大于胎龄的婴儿）的比例从 14.40%降低 30%（p=0.05，80%效力，双侧）。
这是一项随机试验的方案。研究结果将有助于制定基于证据的临床实践指南。
澳大利亚和新西兰临床试验注册 ACTRN12607000161426。
