Physical ActivityFit4TwoNCT04527731
Physical Activity Level During Pregnancy
An observational study of Physical Activity and Well-being, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
This study examines (1) the extent and intensity of physical activity among women in different phases of their pregnancy and (2) the relationship between patterns of physical activity in pregnancy and well-being. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Well-being
- What is being tested?
- Accelerometry
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- 25 Feb 2020to 30 May 2022
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Convenience Sample (female only)
Who may be able to join
- current pregnancy, until pregnancy week 23
Who cannot join
- cognitive impairment
- insufficient language skills
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fit for Two - A Pilot Study on Physical Activity Levels During Pregnancy
This study examines (1) the extent and intensity of physical activity among women in different phases of their pregnancy and (2) the relationship between patterns of physical activity in pregnancy and well-being.
Read the detailed description
This study examines physical activity in different phases of pregnancy using accelerometry. The recruitment of pregnant women (N=30) in the first or second trimester (until week 23) will be realized over different channels (e.g, local newspapers, facebook, and leaflets in gynecological practices, shopping centers, and nurseries).
Informed consent consists of: (i) activity recording over seven consecutive days using an accelerometer, (ii) completion of standardized questionnaires, (iii) participation in a cardiac ultrasound examination in the German Center for Cardiovascular Research (DZHK) - examination center.
Participants are asked to wear an accelerometer at daytime, and over seven consecutive days, in trimester 1 (week 9-12), trimester 2 (week 23-26), and trimester 3 (week 36-39). Women who are attended the study in the first trimester wear the device up to three time whereas those who are attended the study in their second trimester wear the device up to twice. At the end of each measurement period women are invited to fill in a self-administered questionnaire. Also they are invited to participate in a cardiac ultrasound examination. Optionally, participants may receive feedback on their physical activity measured by accelerometer as well as about results of cardiac ultrasound examination upon completion of the study.
- Conditions
- Physical Activity, Well-being
- Being tested
- Accelerometry
- Keywords
- Pregnancy, Physical activity, Accelerometry
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccelerometryDevice
Participants are asked to wear an accelerometer during the day for a period of seven days.
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent and intensity of physical activity between pregnancy week 9 and 12
Assessement via accelerometry
Measured: between pregnancy week 9 and 12
Extent and intensity of physical activity between pregnancy week 23 and 26
Assessement via accelerometry
Measured: between pregnancy week 23 and 26
Extent and intensity of physical activity between pregnancy week 36 and 39
Assessement via accelerometry
Measured: between pregnancy week 36 and 39
Secondary outcomes (13)
Well-being
Assessement via self-administered questionnaire: The World Health Organisation- Five Well-Being Index (WHO-5),The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
Measured: between pregnancy week 9 and 12
Well-being
Assessement via self-administered questionnaire: The World Health Organisation- Five Well-Being Index (WHO-5),The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
Measured: between pregnancy week 23 and 26
Well-being
Assessement via self-administered questionnaire: The World Health Organisation- Five Well-Being Index (WHO-5),The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
Measured: between pregnancy week 36 and 39
Mother-child bond
Assessement via self-administered questionnaire: Maternal Antenatal Attachment Scale (MAAS) consists of 19 items which are scored 1-5, with higher scores indicating higher levels of bonding.
Measured: between pregnancy week 9 and 12
Mother-child bond
Assessement via self-administered questionnaire: Maternal Antenatal Attachment Scale (MAAS) consists of 19 items which are scored 1-5, with higher scores indicating higher levels of bonding.
Measured: between pregnancy week 23 and 26
Mother-child bond
assessement via self-administered questionnaire: Maternal Antenatal Attachment Scale (MAAS) consists of 19 items which are scored 1-5, with higher scores indicating higher levels of bonding.
Measured: between pregnancy week 36 and 39
Sociodemographics
age, education (</=/> school years), partnership, employment status
Measured: between pregnancy week 9 and 12
Left ventricular muscle mass index
Echocardiography will be done by qualified staff.
Measured: Echocardiography between pregnancy week 9 and 12
Left ventricular muscle mass index
Echocardiography will be done by qualified staff.
Measured: cardiac ultrasound measurement between pregnancy week 23 and 26
Left ventricular muscle mass index
Echocardiography will be done by qualified staff.
Measured: Echocardiography between pregnancy week 36 and 39
Echocardiographic global strain, in %
Echocardiography will be done by qualified staff.
Measured: Echocardiography between pregnancy week 9 and 12
Echocardiographic global strain, in %
The cardiac ultrasound examination will be conduced by qualified staff.
Measured: cardiac ultrasound measurement between pregnancy week 23 and 26
Echocardiographic global strain, in %
Echocardiography will be done by qualified staff.
Measured: Echocardiography between pregnancy week 36 and 39
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start25 Feb 2020
- Primary completion30 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Responsible party
- Sponsor
- Investigators
- Sabina Ulbricht, Prof., Principal investigator, University Medicine Greifswald, Dep.Social Medicine and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527731
- Sponsor's protocol ID
- BB002/20
- Acronym
- Fit4Two
- Status last verified
- Dec 2023
- First submitted
- 17 Jun 2020
- Last updated
- 8 Dec 2023
- 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 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fit for Two - A Pilot Study on Physical Activity Levels During Pregnancy
- ClinicalTrials.gov ID
- NCT04527731
- Acronym / sponsor ID
- Fit4Two / BB002/20
- Conditions
- Physical Activity, Well-being
- Keywords
- Pregnancy, Physical activity, Accelerometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Collaborators
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 26 Aug 2020 (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 examines (1) the extent and intensity of physical activity among women in different phases of their pregnancy and (2) the relationship between patterns of physical activity in pregnancy and well-being.
Detailed description
This study examines physical activity in different phases of pregnancy using accelerometry. The recruitment of pregnant women (N=30) in the first or second trimester (until week 23) will be realized over different channels (e.g, local newspapers, facebook, and leaflets in gynecological practices, shopping centers, and nurseries).
Informed consent consists of: (i) activity recording over seven consecutive days using an accelerometer, (ii) completion of standardized questionnaires, (iii) participation in a cardiac ultrasound examination in the German Center for Cardiovascular Research (DZHK) - examination center.
Participants are asked to wear an accelerometer at daytime, and over seven consecutive days, in trimester 1 (week 9-12), trimester 2 (week 23-26), and trimester 3 (week 36-39). Women who are attended the study in the first trimester wear the device up to three time whereas those who are attended the study in their second trimester wear the device up to twice. At the end of each measurement period women are invited to fill in a self-administered questionnaire. Also they are invited to participate in a cardiac ultrasound examination. Optionally, participants may receive feedback on their physical activity measured by accelerometer as well as about results of cardiac ultrasound examination upon completion of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Convenience Sample (female only)
Key inclusion criteria (1 listed)
- current pregnancy, until pregnancy week 23
Key exclusion criteria (2 listed)
- cognitive impairment
- insufficient language skills
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 |
|---|---|---|
| AccelerometryParticipants are asked to wear an accelerometer during the day for a period of seven days. | Device | – |
Primary outcome
Extent and intensity of physical activity between pregnancy week 9 and 12
Time frame: between pregnancy week 9 and 12
Assessement via accelerometry
Extent and intensity of physical activity between pregnancy week 23 and 26
Time frame: between pregnancy week 23 and 26
Assessement via accelerometry
Extent and intensity of physical activity between pregnancy week 36 and 39
Time frame: between pregnancy week 36 and 39
Assessement via accelerometry
13 secondary outcomes
Well-being
Time frame: between pregnancy week 9 and 12
Well-being
Time frame: between pregnancy week 23 and 26
Well-being
Time frame: between pregnancy week 36 and 39
Mother-child bond
Time frame: between pregnancy week 9 and 12
Mother-child bond
Time frame: between pregnancy week 23 and 26
Mother-child bond
Time frame: between pregnancy week 36 and 39
Sociodemographics
Time frame: between pregnancy week 9 and 12
Left ventricular muscle mass index
Time frame: Echocardiography between pregnancy week 9 and 12
Left ventricular muscle mass index
Time frame: cardiac ultrasound measurement between pregnancy week 23 and 26
Left ventricular muscle mass index
Time frame: Echocardiography between pregnancy week 36 and 39
Echocardiographic global strain, in %
Time frame: Echocardiography between pregnancy week 9 and 12
Echocardiographic global strain, in %
Time frame: cardiac ultrasound measurement between pregnancy week 23 and 26
Echocardiographic global strain, in %
Time frame: Echocardiography between pregnancy week 36 and 39
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 8 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Sabina Ulbricht, Prof. principal investigator
University Medicine Greifswald, Dep.Social Medicine and Prevention
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 Physical Activity and Well-being, run by University Medicine Greifswald at 1 site in Germany.
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 2 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 8 Dec 2023. 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 Germany. 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?
Extent and intensity of physical activity between pregnancy week 9 and 12 (time frame: between pregnancy week 9 and 12). The study lists 3 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 8 Dec 2023; AzTrials last refreshed its copy on 29 Oct 2026.