Implementation of the Women's Health Initiative Study Design
Implementation of the Women's Health Initiative Study Design
复制标题
DOI：
10.1016/s1047-2797(03)00043-7
复制
发表时间：
2003-10-01
影响因子：
5.6
通讯作者：
Prentice, RL
中科院分区：
文献类型：
--
作者：
Anderson, GL;Manson, J;Prentice, RL
妇女健康倡议（WHI）临床试验（CT）包括三个重叠的组成部分，每个组成部分都是随机对照比较绝经后和50至79岁的妇女。饮食调整（DM）部分将48，836名（目标48，000名）符合条件的女性随机分配到持续的低脂饮食模式（40%）或自我选择的饮食行为（60%），乳腺癌和结直肠癌作为指定的主要结局，冠心病作为次要结局。分配到DM干预组的女性的营养目标是将总膳食脂肪减少到20%，饱和脂肪减少到每日卡路里的7%以下，其次，将蔬菜和水果的每日摄入量增加到至少5份，谷物产品增加到至少6份，并在整个试验随访期间保持这些变化。将40%而不是50%的参与女性随机分配到DM干预组旨在降低试验成本，同时以指定的功效检验试验假设。
The Women’s Health Initiative (WHI) Clinical Trial (CT) includes three overlapping components, each a randomized controlled comparison among women who were postmenopausal and 50 to 79 years of age at randomization. The dietary modification (DM) component randomly assigned 48,836 (target 48,000) eligible women to either a sustained low-fat eating pattern (40%) or self-selected dietary behavior (60%), with breast cancer and colorectal cancer as designated primary outcomes and coronary heart disease as a secondary outcome. The nutrition goals for women assigned to the DM intervention group have been to reduce total dietary fat to 20%, and saturated fat to less than 7% of daily calories and, secondarily, to increase daily servings of vegetables and fruits to at least five and of grain products to at least six and to maintain these changes throughout trial follow-up. The randomization of 40%, rather than 50%, of participating women to the DM intervention group was intended to reduce trial costs, while testing trial hypotheses with specified power.