Chen Xin, Deng Yong-Fang, Fu Chun-Feng, Yang Xiao, Gao Lingling
School of Nursing, Sun Yat-sen University, 74#, Zhongshan Road II, Guangzhou, 510089, China.
Department of Obstetrics and Gynecology, Guangzhou Women and Children's Medical Center, Guangzhou, China.
BMC Pregnancy Childbirth. 2025 Mar 8;25(1):264. doi: 10.1186/s12884-025-07268-x.
Pregnancy may result in gestational diabetes mellitus (GDM), discomfort, pregnancy-related musculoskeletal pain, sleep disturbances, and decreased quality of life in pregnant women. Physical activity during pregnancy can lower the odds ratio of developing GDM and offer numerous health benefits for mothers and infants. However, the prevalence of physical inactivity among pregnant women worldwide is high. The Behavior Change Wheel (BCW) can be used to develop interventions to enhance physical activity. However, no research has been conducted to evaluate the effectiveness of physical activity interventions among Chinese pregnant women using the BCW framework.
METHODS/DESIGN: We will conduct a single-center, parallel, randomized controlled trial at a maternal-child health care center. A total of 244 pregnant women at high risk for GDM will be randomly allocated to either a study group receiving a physical activity counseling intervention or a control group receiving standard care. The intervention will comprise one face-to-face individual counseling session combined with three weekly online group counseling sessions based on Motivational Interviewing, supplemented by four biweekly counseling before 24 gestation weeks, and WeChat group support (Tencent, Shenzhen, China). Educational materials will also be available on the WeChat Official Account. The program will begin before 12 gestational weeks, the counseling sessions will end before 24 gestation weeks and WeChat group support will end before delivery. The primary outcomes will include physical activity, the incidence of GDM and glucose level. The secondary outcomes will include gestational weight gain, sleep quality, quality of life, low back pain, pelvic girdle pain, physical activity-related variables, and maternal and newborns health outcomes.
This research will contribute to understanding the effects of a physical activity counseling intervention, including physical activity, incidence of GDM, glucose levels, gestational weight gain, sleep quality, quality of life, low back and pelvic girdle pain, and maternal and newborn health outcomes.
Chinese Clinical Trial Registry (CHiCTR) ChiCTR2400081364, on February 29, 2024.
怀孕可能导致妊娠期糖尿病（GDM）、不适、与妊娠相关的肌肉骨骼疼痛、睡眠障碍，并降低孕妇的生活质量。孕期进行体育活动可以降低患妊娠期糖尿病的几率，并为母婴带来诸多健康益处。然而，全球范围内孕妇身体活动不足的患病率很高。行为改变轮（BCW）可用于制定促进体育活动的干预措施。然而，尚未有研究使用BCW框架评估中国孕妇体育活动干预措施的有效性。
方法/设计：我们将在一家妇幼保健中心进行一项单中心、平行、随机对照试验。总共244名妊娠期糖尿病高危孕妇将被随机分配到接受体育活动咨询干预的研究组或接受标准护理的对照组。干预措施将包括一次面对面的个体咨询会议，结合基于动机性访谈的三次每周在线小组咨询会议，在妊娠24周前每两周补充进行四次咨询，并提供微信小组支持（中国深圳腾讯公司）。微信公众号上也将提供教育材料。该计划将在妊娠12周前开始，咨询会议将在妊娠24周前结束，微信小组支持将在分娩前结束。主要结局将包括体育活动、妊娠期糖尿病的发病率和血糖水平。次要结局将包括孕期体重增加、睡眠质量、生活质量、腰痛、骨盆带疼痛、与体育活动相关的变量以及母婴健康结局。
本研究将有助于了解体育活动咨询干预的效果，包括体育活动、妊娠期糖尿病发病率、血糖水平、孕期体重增加、睡眠质量、生活质量、腰和骨盆带疼痛以及母婴健康结局。
中国临床试验注册中心（CHiCTR）ChiCTR2400081364，于2024年2月29日注册。
