NCT06413303

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 14, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

9 months

First QC Date

May 9, 2024

Last Update Submit

May 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Gestational weight gain

    Weight before delivery minus weight before pregnancy.

    From date of enrollment until the date of delivery.

Study Arms (2)

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.

Behavioral: Experiential Classroom

Standard Clinic Prenatal Care Group

NO INTERVENTION

Participants accept regular routine prenatal care following Chinese standard.

Interventions

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.

Experiential Classroom Group

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of ob gyn, Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Liangkun Ma

    Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2024

First Posted

May 14, 2024

Study Start

December 20, 2023

Primary Completion

September 1, 2024

Study Completion

May 1, 2025

Last Updated

May 14, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations