通过产前饮食、生活方式和体育活动建议优化孕期体重增加并改善母婴健康结局：OPTIMISE随机对照试验方案
Optimising gestational weight gain and improving maternal and infant health outcomes through antenatal dietary, lifestyle and physical activity advice: the OPTIMISE randomised controlled trial protocol.
作者信息
Dodd Jodie M, Deussen Andrea R, Louise Jennie
机构信息
Discipline of Obstetrics and Gynaecology, Robinson Research Institute, The University of Adelaide, Adelaide, South Australia, Australia.
Department of Perinatal Medicine, Women's and Children's Hospital, North Adelaide, South Australia, Australia.
出版信息
BMJ Open. 2018 Feb 20;8(2):e019583. doi: 10.1136/bmjopen-2017-019583.
INTRODUCTION
Obesity represents a significant health burden, and WHO recognises the importance of preventing weight gain and subsequent development of obesity among adults who are within the healthy weight range. Women of reproductive age have demonstrated high rates of weight gain during pregnancy placing them at risk of becoming overweight or obese. We will evaluate the effects of dietary and physical activity advice on maternal, fetal and infant health outcomes, among pregnant women of normal body mass index (BMI).
METHODS AND ANALYSIS
We will conduct a randomised controlled trial, consenting and randomising women with a live singleton pregnancy between 10 and 20 weeks and BMI 18.5-24.9 kg/m at first antenatal visit, from a tertiary maternity hospital. Women randomised to the will receive three face-to-face sessions (two with a research dietitian and one with a trained research assistant) and three telephone calls over pregnancy, in which they will be provided with dietary and lifestyle advice and encouraged to make change using a SMART goals approach. Women randomised to the will receive routine antenatal care. The primary outcome is infant birth weight >4 kg. Secondary outcomes will include adverse infant and maternal outcomes, maternal weight change, maternal diet and physical activity changes, maternal quality of life and emotional well-being, fetal growth and costs of healthcare. We will recruit 624 women to detect a reduction from 8.72% to 3.87% (alpha 0.05 (two-tailed); power 70%) in infants with birth weight >4 kg. Analyses will be intention to treat with estimates reported as relative risks and 95% CIs.
ETHICS AND DISSEMINATION
Ethical approval has been obtained from the Women's and Children's Hospital ethics committee. Findings will be disseminated widely via journal publication and conference presentation(s), and participants informed of results.
TRIAL REGISTRATION NUMBER
ACTRN12614000583640.
引言
肥胖是一项重大的健康负担，世界卫生组织认识到预防健康体重范围内的成年人体重增加及随后发生肥胖的重要性。育龄妇女在孕期体重增加率较高，这使她们有超重或肥胖的风险。我们将评估饮食和身体活动建议对正常体重指数（BMI）的孕妇的母婴健康结局的影响。
方法与分析
我们将进行一项随机对照试验，从一家三级妇产医院招募妊娠10至20周、首次产前检查时BMI为18.5 - 24.9 kg/m²且怀有单胎活胎的妇女，使其同意参与并进行随机分组。随机分配到干预组的妇女将在孕期接受三次面对面咨询（两次由研究营养师进行，一次由经过培训的研究助理进行）和三次电话咨询，期间会为她们提供饮食和生活方式建议，并鼓励她们采用SMART目标法做出改变。随机分配到对照组的妇女将接受常规产前护理。主要结局是婴儿出生体重>4 kg。次要结局将包括不良的母婴结局、孕妇体重变化、孕妇饮食和身体活动变化、孕妇生活质量和情绪健康、胎儿生长以及医疗保健费用。我们将招募624名妇女，以检测出生体重>4 kg的婴儿比例从8.72%降至3.87%（α = 0.05（双侧）；检验效能70%）。分析将采用意向性分析，估计值报告为相对风险和95%置信区间。
伦理与传播
已获得妇女儿童医院伦理委员会的伦理批准。研究结果将通过期刊发表和会议报告广泛传播，并向参与者通报结果。
试验注册号
ACTRN12614000583640。
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