Matsuzaki Masayo, Kusaka Momoko, Sugimoto Takashi, Shiraishi Mie, Kobayashi Risa, Watanabe Sachi, Haruna Megumi
1 Division of Health Sciences and Nursing, Department of Midwifery and Women's Health, Graduate School of Medicine, The University of Tokyo , Tokyo, Japan .
2 Division of Health Science, Department of Children and Women's Health, Graduate School of Medicine, Osaka University , Osaka, Japan .
J Altern Complement Med. 2018 Jun;24(6):603-610. doi: 10.1089/acm.2017.0119. Epub 2018 Feb 14.
This report provides an experimental protocol for a study designed to verify the effects of yoga exercise and a nutritional guidance program during pregnancy on several key pregnancy and birth outcomes among Japanese women.
This is a study protocol of a randomized controlled trial.
SETTING/LOCATION: This intervention will be carried out in a university hospital in Tokyo.
Healthy primiparous women will be recruited at 18-23 gestational weeks in the hospital. A total of 400 participants will be randomly assigned to one of four groups in this trial, with 100 participants in each group-group with yoga exercise, with nutritional guidance, with both yoga and nutritional guidance, and with standard care alone, as the control group. Yoga exercise consists of yoga classes held at the hospital 3 or 5 days a month, duration 60 min, and home practice using a digital video disk, duration 30 or 60 min per session. We recommend participants do yoga at least 3 days a week for a total of 60 min per day. Nutritional guidance is based on individual dietary intake assessed using a brief-type diet history questionnaire.
The primary outcome is rate of pregnant women with adequate gestational weight gain. Secondary outcomes include physiologic and psychologic status assessed via biomarkers and health-related scales, dietary nutrition intake, and birth outcomes.
This study shows the effects of a yoga exercise and nutritional intervention. If the intervention is found to be effective, our results will be useful for healthcare providers and pregnant women.
本报告提供了一项研究的实验方案，该研究旨在验证孕期瑜伽锻炼和营养指导计划对日本女性若干关键妊娠和分娩结局的影响。
这是一项随机对照试验的研究方案。
设置/地点：本干预将在东京的一家大学医院进行。
将在医院对妊娠18 - 23周的健康初产妇进行招募。本试验中，共有400名参与者将被随机分配到四组中的一组，每组100人——瑜伽锻炼组、营养指导组、瑜伽和营养指导组以及仅接受标准护理的对照组。瑜伽锻炼包括每月在医院进行3天或5天、每次时长60分钟的瑜伽课程，以及使用数字视频光盘在家练习，每次时长30或60分钟。我们建议参与者每周至少进行3天瑜伽锻炼，每天总计60分钟。营养指导基于使用简短型饮食史问卷评估的个人饮食摄入量。
主要结局是孕期体重增加充足的孕妇比例。次要结局包括通过生物标志物和健康相关量表评估的生理和心理状态、饮食营养摄入量以及分娩结局。
本研究显示了瑜伽锻炼和营养干预（计划）的效果。如果发现该干预有效，我们的研究结果将对医疗保健提供者和孕妇有用。
