Jin Ying, Zhang Wei, Zhang Le, Zhang Xuesong, Shen Yu, Liu Ningning, Feng Suwen
Women's Hospital School of Medicine Zhejiang University, Hangzhou, Zhejiang, China.
Women's Hospital School of Medicine Zhejiang University, Hangzhou, Zhejiang, China
BMJ Open. 2025 Jan 7;15(1):e085910. doi: 10.1136/bmjopen-2024-085910.
Physical inactivity is a global concern and poses serious health risks. Physical inactivity is exacerbated and affects the health of both generations during the special period of pregnancy. Appropriate physical activity (PA) intervention programmes based on health behaviour change theory are lacking. This study aims to evaluate the effectiveness of a PA intervention based on the multi-theory model (MTM) by assessing changes in PA levels, MTM constructs, exercise self-efficacy, quality of life, prenatal depressive symptoms, gestational weight gain and pregnancy and delivery outcomes.
This single-centre, parallel, randomised, controlled trial will be conducted at a tertiary care institution in Hangzhou, China. A total of 72 pregnant women without contraindications to exercise at 14-27 weeks+6 days of gestation will be included. Participants will be randomly assigned to either the intervention or control group. The intervention group will engage in a 12 week PA intervention programme based on the MTM and delivered through WeChat, while the control group will receive standard antenatal care. Data will be collected at baseline, 6 weeks of the intervention, 12 weeks of the intervention and within 1 week of delivery. The primary outcomes will include PA levels measured by accelerometers and the PA in Pregnancy Questionnaire, along with the constructs of the MTM. Secondary outcomes will comprise exercise self-efficacy during pregnancy, quality of life, prenatal depressive symptoms, gestation weight gain and pregnancy and delivery outcomes. Data analysis will adhere to the Consolidated Standards of Reporting Trials 2010 statement and follow the intention-to-treat principle.
The study followed the ethical guidelines approved by the ethics committee of Women's Hospital School of Medicine Zhejiang University (IRB-20230254-R, Approval Date: 27 July 2023). The results of the study will be submitted for publication and dissemination in a peer-reviewed journal. Participants will receive clarification regarding the study objectives, procedures and will be asked to sign informed consent in written form before the start of the study.
ChiCTR2400080843. Prospectively registered on 8 February 2024.
身体活动不足是一个全球性问题，会带来严重的健康风险。在孕期这一特殊时期，身体活动不足的情况会加剧，且会影响两代人的健康。目前缺乏基于健康行为改变理论的适当身体活动（PA）干预项目。本研究旨在通过评估PA水平、多理论模型（MTM）结构、运动自我效能、生活质量、产前抑郁症状、孕期体重增加以及妊娠和分娩结局的变化，来评价基于MTM的PA干预的有效性。
本单中心、平行、随机对照试验将在中国杭州的一家三级医疗机构进行。共纳入72名在妊娠14 - 27周+6天无运动禁忌证的孕妇。参与者将被随机分配到干预组或对照组。干预组将参加一项基于MTM并通过微信开展的为期12周的PA干预项目，而对照组将接受标准的产前护理。数据将在基线、干预6周、干预12周以及分娩后1周内收集。主要结局将包括通过加速度计测量的PA水平和《孕期身体活动问卷》，以及MTM的结构。次要结局将包括孕期运动自我效能、生活质量、产前抑郁症状、孕期体重增加以及妊娠和分娩结局。数据分析将遵循《2010年报告试验的统一标准》声明并遵循意向性分析原则。
本研究遵循浙江大学医学院附属妇产科医院伦理委员会批准的伦理准则（IRB - 20230254 - R，批准日期：2023年7月27日）。研究结果将提交至同行评审期刊发表和传播。在研究开始前，参与者将收到关于研究目的、程序的说明，并被要求签署书面知情同意书。
ChiCTR2400080843。于2024年2月8日进行前瞻性注册。
