Pregnancy RelatedNCT05250297
Physical Activity and Symptom Disturbance Regarding Cross-Trimester
An observational study of Pregnancy Related, run by Mackay Medical College at 1 site in Taiwan.
Trial summary
This study will explore pregnant women's regular exercise intentions and behavior across trimesters (from first trimester, second trimester to third trimester). Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- How many people
- 277 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 May 2018to 31 Dec 2019
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The participants were recruited from the prenatal outpatient departments of hospitals in Taipei, Taiwan.
Who may be able to join
- Inclusion criteria were women in 8-16 weeks of gestation with a singleton pregnancy who had no obstetric or medical complications
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pregnant Women's Intention and Behavioral Regarding Cross-Trimester Regular Exercise-Based on the Theory of Planned Behavior
This study will explore pregnant women's regular exercise intentions and behavior across trimesters (from first trimester, second trimester to third trimester).
Read the detailed description
Based on the TPB, this study will explore pregnant women's regular exercise intentions and behavior across trimesters (from first trimester, second trimester to third trimester). Moreover, the study will explore the effect factors, predictors and transition factors regarding pregnant women's regular exercise intention and behavior across trimesters.
- Conditions
- Pregnancy Related
- Being tested
- no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
standard prenatal care
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: The data were collected before the intervention to childbirth: <16 week gestation, second trimester (24-28 weeks), third trimester (>36 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start14 May 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 277 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Mackay Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chin-Tsung Shen, Mackay Medical College
- Investigators
- Ching-Fang Lee, PhD, Principal investigator, Mackay Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250297
- Sponsor's protocol ID
- LCF-MMC107
- Status last verified
- Feb 2022
- First submitted
- 10 Feb 2022
- Last updated
- 22 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnant Women's Intention and Behavioral Regarding Cross-Trimester Regular Exercise-Based on the Theory of Planned Behavior
- ClinicalTrials.gov ID
- NCT05250297
- Acronym / sponsor ID
- LCF-MMC107
- Conditions
- Pregnancy Related
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- Mackay Medical CollegeUniversity, hospital or other
- Study start
- 14 May 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 22 Feb 2022 (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.
This study will explore pregnant women's regular exercise intentions and behavior across trimesters (from first trimester, second trimester to third trimester).
Detailed description
Based on the TPB, this study will explore pregnant women's regular exercise intentions and behavior across trimesters (from first trimester, second trimester to third trimester). Moreover, the study will explore the effect factors, predictors and transition factors regarding pregnant women's regular exercise intention and behavior across trimesters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The participants were recruited from the prenatal outpatient departments of hospitals in Taipei, Taiwan.
Key inclusion criteria (1 listed)
- Inclusion criteria were women in 8-16 weeks of gestation with a singleton pregnancy who had no obstetric or medical complications
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| no interventionstandard prenatal care | Other | – |
Primary outcome
Change of physical activity across different trimesters of pregnancy
Time frame: The data were collected before the intervention to childbirth: <16 week gestation, second trimester (24-28 weeks), third trimester (>36 weeks)
The pregnancy physical activity questionnaire (PPAQ) was used to measure women's physical activity during pregnancy
Change of symptom distress across different trimesters of pregnancy
Time frame: The data were collected before the intervention to childbirth: <16 week gestation, second trimester (24-28 weeks), third trimester (>36 weeks)
The pregnancy-related symptom Disturbance was used to measure women's symptom disturbance. The highest total score was severe levels of pregnancy-related distress.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
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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.
Ching-Fang Lee, PhD principal investigator
Mackay Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by Mackay Medical College at 1 site in Taiwan.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 22 Feb 2022. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of physical activity across different trimesters of pregnancy (time frame: The data were collected before the intervention to childbirth: <16 week gestation, second trimester (24-28 weeks), third trimester (>36 weeks)). The study lists 2 primary outcomes in all. 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 22 Feb 2022.