NCT05250297

Brief Summary

This study will explore pregnant women's regular exercise intentions and behavior across trimesters (from first trimester, second trimester to third trimester).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
277

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 14, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
Last Updated

February 22, 2022

Status Verified

February 1, 2022

Enrollment Period

8 months

First QC Date

February 10, 2022

Last Update Submit

February 10, 2022

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (2)

  • Change of physical activity across different trimesters of pregnancy

    The pregnancy physical activity questionnaire (PPAQ) was used to measure women's physical activity during pregnancy

    The data were collected before the intervention to childbirth: <16 week gestation, second trimester (24-28 weeks), third trimester (>36 weeks)

  • Change of symptom distress across different trimesters of pregnancy

    The pregnancy-related symptom Disturbance was used to measure women's symptom disturbance. The highest total score was severe levels of pregnancy-related distress.

    The data were collected before the intervention to childbirth: <16 week gestation, second trimester (24-28 weeks), third trimester (>36 weeks)

Interventions

no interventionOTHER

standard prenatal care

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The participants were recruited from the prenatal outpatient departments of hospitals in Taipei, Taiwan.

You may not qualify if:

  • Excluded were those who had American college of Obstetrics and Gynecology (ACOG) absolutely contraindication exercise, such as insulin-dependent diabetes, gestational diabetes, hypertension, and multiple-gestation pregnancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nursing

New Taipei City, Taiwan

Location

Study Officials

  • Ching-Fang Lee, PhD

    Mackay Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
the Office of Research and Development

Study Record Dates

First Submitted

February 10, 2022

First Posted

February 22, 2022

Study Start

May 14, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2019

Last Updated

February 22, 2022

Record last verified: 2022-02

Locations

TW(1)