Physical Activity Level During Pregnancy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Fit for Two - A Pilot Study on Physical Activity Levels During Pregnancy

Conditions
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Physical Activity, Well-being

Intervention / Treatment
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* Device: Accelerometry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - current pregnancy, until pregnancy week 23 Exclusion Criteria: cognitive impairment insufficient language skills

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Accelerometry|Participants are asked to wear an accelerometer during the day for a period of seven days.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Physical activity, Accelerometry