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临床试验/NCT06413303
NCT06413303招募中不适用

The Effect of Experiential Classroom on Establishing Healthy Behaviors During Pregnancy

Peking Union Medical College Hospital2 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2023年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
136
试验地点
2
主要终点
Gestational weight gain

研究概览

简要总结

A multi-center, prospective, randomized controlled clinical trial was conducted to explore the effect of experiential classroom on establishing healthy behaviors during pregnancy.

详细描述

Adverse pregnancy outcomes, including maternal complications (eg, gestational hypertension, preeclampsia (PE), gestational diabetes mellitus (GDM), placental abruption) and fetal complications (eg, preterm birth, intrauterine growth restriction, large for gestational age (LGA), small for gestational age (SGA), macrosomia) , pose a significant public healthy problem which needs to be addressed. Several studies found that the health status and behaviors of mothers during pregnancy, including dietary patterns, physical activity and emotional well-being, not only affect pregnancy outcomes such as GDM and PE, but also have the long-term implications for the health of the offspring. Therefore, through effective preconception education, helping pregnant women establish healthy behaviors during pregnancy is of great significance in reducing the incidence of adverse pregnancy outcomes. However, traditional educational methods, mostly in the form of face-to-face lectures, have proven to be ineffective. On the other hand, experiential classroom emphasizes putting pregnant women at the center, based on their subjective willingness and previous knowledge and experience, creating an environment for free discussion, exchange, and reflection, and utilizing peer education to fully mobilize the subjective initiative of pregnant women. This approach allows them to explore, discuss, reflect, and learn autonomously, aiming to truly absorb, master, and apply theoretical knowledge. Therefore, to explore the impact of experiential classroom on the establishment of healthy behaviors during pregnancy, we conducted a multicenter, prospective, randomized controlled clinical trial. The study included pregnant women aged 20 and above, married, with singleton pregnancies in early pregnancy, who were randomly assigned to either the experiential classroom group or the routine prenatal care group. Both groups received routine prenatal care. The pregnant women in the personalized exercise guidance group learned about perinatal health knowledge under the guidance of multidisciplinary teachers and were supervised and managed through WeChat groups. The primary outcome measure was the total weight gain during pregnancy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Older than
  • Singleton pregnancy.
  • The first trimester.
  • Be able to undergo regular prenatal follow-ups and delivery in PUMCH.
  • Be able to participate in each experiential classroom on time.
  • Capable of independently completing questionnaire surveys.

排除标准

  • With severe mental illness.
  • Severe impairment of liver and kidney function.
  • With malignant tumors.
  • With contraindications to exercise during pregnancy.

结局指标

主要结局

Gestational weight gain

时间窗: From date of enrollment until the date of delivery.

Weight before delivery minus weight before pregnancy.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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