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| Name | Class |
|---|---|
| Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accelerometry | Device | Participants are asked to wear an accelerometer during the day for a period of seven days. |
| Measure | Description | Time Frame |
|---|---|---|
| Extent and intensity of physical activity between pregnancy week 9 and 12 | Assessement via accelerometry | between pregnancy week 9 and 12 |
| Extent and intensity of physical activity between pregnancy week 23 and 26 | Assessement via accelerometry | between pregnancy week 23 and 26 |
| Extent and intensity of physical activity between pregnancy week 36 and 39 | Assessement via accelerometry | between pregnancy week 36 and 39 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | between pregnancy week 9 and 12 |
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Inclusion Criteria:
- current pregnancy, until pregnancy week 23
Exclusion Criteria:
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Convenience Sample (female only)
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| Name | Affiliation | Role |
|---|---|---|
| Sabina Ulbricht, Prof. | University Medicine Greifswald, Dep.Social Medicine and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medicine Greifswald | Greifswald | 17475 | Germany |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 10, 2020 | Aug 11, 2020 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D061725 | Accelerometry |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| 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. | 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. | 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. | 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. | 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. | between pregnancy week 36 and 39 |
| Sociodemographics | age, education (</=/> school years), partnership, employment status | between pregnancy week 9 and 12 |
| Left ventricular muscle mass index | Echocardiography will be done by qualified staff. | Echocardiography between pregnancy week 9 and 12 |
| Left ventricular muscle mass index | Echocardiography will be done by qualified staff. | cardiac ultrasound measurement between pregnancy week 23 and 26 |
| Left ventricular muscle mass index | Echocardiography will be done by qualified staff. | Echocardiography between pregnancy week 36 and 39 |
| Echocardiographic global strain, in % | Echocardiography will be done by qualified staff. | Echocardiography between pregnancy week 9 and 12 |
| Echocardiographic global strain, in % | The cardiac ultrasound examination will be conduced by qualified staff. | cardiac ultrasound measurement between pregnancy week 23 and 26 |
| Echocardiographic global strain, in % | Echocardiography will be done by qualified staff. | Echocardiography between pregnancy week 36 and 39 |