中国产后妇女的饮食和生活方式干预：一项多中心随机对照试验的研究设计和原理。
Diet and lifestyle interventions in postpartum women in China: study design and rationale of a multicenter randomized controlled trial.
机构信息
Department of Nutrition and Food Hygiene and MOE Key Lab of Environment and Health, School of Public Health, Tongji Medical College, Huazhong University of Science & Technology, Wuhan 430030, PR China.
出版信息
BMC Public Health. 2010 Feb 27;10:103. doi: 10.1186/1471-2458-10-103.
BACKGROUND
"Doing the month", or "sitting month", is a traditional practice for postpartum women in China and other Asian countries, which includes some taboos against well-accepted healthy diet and lifestyles in general population. Previous studies have shown this practice may be associated with higher prevalence of postpartum problems. The current multicenter randomized controlled trial (RCT) aims to evaluate outcomes of diet and lifestyle interventions in Chinese postpartum women.
METHODS/DESIGN: The current multicenter RCT will be conducted in three representative areas in China, Shandong province, Hubei province and Guangdong province, which locate in northern, central and southern parts of China, respectively. Women who attend routine pregnancy diagnosis in hospitals or maternal healthcare centers will be invited to take part in this study. At least 800 women who meet our eligibility criteria will be recruited and randomly assigned to the intervention group (n > = 400) and the control group (n > = 400). A three-dimension comprehensive intervention strategy, which incorporates intervention measures simultaneously to individual postpartum woman, their family members and community environment, will be utilized to maximize the effectiveness of intervention. Regular visiting and follow-up will be done in both group; nutrition and health-related measurements will be assessed both before and after the intervention.
DISCUSSION
To our knowledge, this current study is the first and largest multicenter RCT which focus on the effectiveness of diet and lifestyle intervention on reducing the incidence rate of postpartum diseases and improving health status in postpartum women. We hypothesize that the intervention will reduce the incidence rates of postpartum diseases and improve nutrition and health status due to a balanced diet and reasonable lifestyle in comparison with the control condition. If so, the results of our study will provide especially important evidence for changes in both the concept and action of traditional postpartum practice in China.
TRIAL REGISTRATION
ClinicalTrials.gov ID NCT01039051.
背景
“坐月子”是中国和其他亚洲国家的一种传统产后习俗，其中包括一些针对普遍接受的健康饮食和生活方式的禁忌。先前的研究表明，这种做法可能与更高的产后问题发生率有关。目前这项多中心随机对照试验（RCT）旨在评估中国产后妇女的饮食和生活方式干预的结果。
方法/设计：目前这项多中心 RCT 将在中国三个有代表性的地区进行，即山东省、湖北省和广东省，它们分别位于中国的北部、中部和南部。将邀请在医院或母婴保健中心进行常规妊娠诊断的妇女参加这项研究。将招募至少 800 名符合我们入选标准的妇女，并将她们随机分配到干预组（n > = 400）和对照组（n > = 400）。将采用一种三维综合干预策略，同时将干预措施应用于个体产后妇女、她们的家庭成员和社区环境，以最大限度地提高干预的效果。将对两组都进行定期访问和随访；在干预前后都将评估营养和健康相关的测量。
讨论
据我们所知，目前这项研究是第一个也是最大的多中心 RCT，专注于饮食和生活方式干预对降低产后疾病发生率和改善产后妇女健康状况的效果。我们假设干预将通过均衡饮食和合理的生活方式，与对照组相比，降低产后疾病的发生率，并改善营养和健康状况。如果是这样，我们的研究结果将为中国传统产后习俗在观念和行动上的改变提供特别重要的证据。
试验注册
ClinicalTrials.gov ID NCT01039051。
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