Clinical trial NCT06413303: The Effect of Experiential Classroom on Establishing Healthy Behaviors During Pregnancy
Official title: The Effect of Experiential Classroom on Establishing Healthy Behaviors During Pregnancy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Experiential Classroom
Health Behavior
Preconception Education
Adverse Pregnancy Outcome
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 136
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Older than 20.
* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Gestational weight gain
timeFrame: From date of enrollment until the date of delivery.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of ob gyn, Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
name: Liangkun Ma
role: STUDY_CHAIR
References: