Experiential ClassroomNCT06413303
The Effect of Experiential Classroom on Establishing Healthy Behaviors During Pregnancy
A study testing Experiential Classroom in people with Experiential Classroom and Health Behavior, run by Peking Union Medical College Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Experiential Classroom, Health Behavior, Preconception Education
- What is being tested?
- Experiential Classroom
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2023to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- With severe mental illness.
- Severe impairment of liver and kidney function.
- With malignant tumors.
- With contraindications to exercise during pregnancy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of ob gyn, Peking Union Medical College Hospital
Beijing, 100730
Liangkun Ma, 13021961166 ext. +86, maliangkun@pumch.cn
About this study
A multi-center, prospective, randomized controlled clinical trial was conducted to explore the effect of experiential classroom on establishing healthy behaviors during pregnancy.
Read the 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.
- Conditions
- Experiential Classroom, Health Behavior, Preconception Education, Adverse Pregnancy Outcome
- Being tested
- Experiential Classroom
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experiential ClassroomBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experiential Classroom Group | Experimental | Participants accept experiential class to establish healthy behaviors. They are also managed continuously through WeChat group chat during prenatal clinical interval. Receives: Behavioral: Experiential Classroom |
| Standard Clinic Prenatal Care Group | No intervention | Participants accept regular routine prenatal care following Chinese standard. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational weight gain
Weight before delivery minus weight before pregnancy.
Measured: From date of enrollment until the date of delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start20 Dec 2023
- Primary completionSep 2024 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Experiential ClassroomStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liangkun Ma, Study chair, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413303
- Sponsor's protocol ID
- K3955
- Status last verified
- May 2024
- First submitted
- 9 May 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Experiential Classroom on Establishing Healthy Behaviors During Pregnancy
- ClinicalTrials.gov ID
- NCT06413303
- Acronym / sponsor ID
- K3955
- Conditions
- Experiential Classroom, Health Behavior, Preconception Education, Adverse Pregnancy Outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experiential Classroom Group | Experimental | Behavioral: Experiential ClassroomParticipants accept experiential class to establish healthy behaviors. They are also managed continuously through WeChat group chat during prenatal clinical interval. |
| Standard Clinic Prenatal Care Group | No intervention | –Participants accept regular routine prenatal care following Chinese standard. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- With severe mental illness.
- Severe impairment of liver and kidney function.
- With malignant tumors.
- With contraindications to exercise during pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experiential ClassroomExperiential 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. | Behavioural | Experiential Classroom Group |
Primary outcome
Gestational weight gain
Time frame: From date of enrollment until the date of delivery.
Weight before delivery minus weight before pregnancy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liangkun Ma study chair
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experiential Classroom in people with Experiential Classroom and Health Behavior, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liangkun Ma (13021961166 ext. +86, maliangkun@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational weight gain (time frame: From date of enrollment until the date of delivery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.