Healthy Moms, a randomized trial to promote and evaluate weight maintenance among obese pregnant women: study design and rationale.
Healthy Moms, a randomized trial to promote and evaluate weight maintenance among obese pregnant women: study design and rationale.
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DOI：
10.1016/j.cct.2012.03.006
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发表时间：
2012-07
影响因子：
2.2
通讯作者：
Stevens VJ
中科院分区：
文献类型：
--
作者：
Vesco KK;Karanja N;King JC;Gillman MW;Perrin N;McEvoy C;Eckhardt C;Smith KS;Stevens VJ
怀孕期间肥胖和体重过度增加与不良妊娠结局有关。观察性研究表明，妊娠期体重增加（GWG）最小或没有可能降低肥胖妇女不良妊娠结局的风险。本报告描述了健康妈妈的设计，这是一项随机试验，测试每周一次，基于组的体重管理干预措施，旨在帮助将肥胖孕妇（BMI ≥30 kg/m2）的GWG限制在体重（随机化时测量）的3%。参与者在妊娠10-20周时被随机分配到干预或单一饮食建议控制条件。该研究的主要结局是总GWG，目标样本量为160名女性。其他次要结局包括随机化和产后一年之间的体重变化以及出生体重>胎龄第90百分位数的婴儿比例。统计分析将基于意向治疗。随机分组后，所有参与者接受45分钟的饮食咨询。鼓励他们遵循饮食方法来停止高血压饮食，而不限制钠。干预组的参与者接受个性化的卡路里摄入量目标，第二次个人咨询会议，并参加每周的小组会议，直到他们分娩。研究人员在妊娠34周以及产后2周和1年时对所有参与者及其婴儿进行评估。健康妈妈研究正在测试用于非怀孕成年人的体重管理技术。我们的目标是帮助肥胖妇女限制GWG，以改善其长期健康和后代的健康。
Obesity and excessive weight gain during pregnancy are associated with adverse pregnancy outcomes. Observational studies suggest that minimal or no gestational weight gain (GWG) may minimize the risk of adverse pregnancy outcomes for obese women. This report describes the design of Healthy Moms, a randomized trial testing a weekly, group-based, weight management intervention designed to help limit GWG to 3% of weight (measured at the time of randomization) among obese pregnant women (BMI ≥30 kg/m2). Participants are randomized at 10–20 weeks gestation to either the intervention or a single dietary advice control condition. The study is powered for the primary outcome of total GWG, yielding a target sample size of 160 women. Additional secondary outcomes include weight change between randomization and one-year postpartum and proportion of infants with birth weight > 90th percentile for gestational age. Statistical analyses will be based on intention-to-treat. Following randomization, all participants receive a 45-minute dietary consultation. They are encouraged to follow the Dietary Approaches to Stop Hypertension diet without sodium restriction. Intervention group participants receive an individualized calorie intake goal, a second individual counseling session and attend weekly group meetings until they give birth. Research staff assess all participants at 34-weeks gestation and at 2-weeks and one-year postpartum with their infants. The Healthy Moms study is testing weight management techniques that have been used with non-pregnant adults. We aim to help obese women limit GWG to improve their long-term health and the health of their offspring.
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