The Effect of Experiential Classroom on Establishing Healthy Behaviors During Pregnancy

Health Behavior Clinical Trial

Official title:

The Effect of Experiential Classroom on Establishing Healthy Behaviors During Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06413303
• Other study ID #: K3955
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2023
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: Peking Union Medical College Hospital
• Contact: Liangkun Ma
• Phone: 13021961166
• Email: maliangkun[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: May 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adverse Pregnancy Outcome
• Health Behavior

Intervention

Behavioral:
• Experiential Classroom
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.

Locations

Country	Name	City	State
China	Department of ob gyn, Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational weight gain	Weight before delivery minus weight before pregnancy.	From date of enrollment until the date of delivery.