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Completed

NCT Number: NCT04527731

Physical Activity Level 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.

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Key information

Conditions

Physical Activity Behavior Motor Activity Well-Being

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University Medicine Greifswald

Greifswald, 17475, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • current pregnancy, until pregnancy week 23

Exclusion criteria

  • cognitive impairment
  • insufficient language skills

Treatment and study plan

Accelerometry

Device

Participants are asked to wear an accelerometer during the day for a period of seven days.

Primary outcomes

  1. Extent and intensity of physical activity between pregnancy week 9 and 12

    Time frame: between pregnancy week 9 and 12

    Assessement via accelerometry

  2. Extent and intensity of physical activity between pregnancy week 23 and 26

    Time frame: between pregnancy week 23 and 26

    Assessement via accelerometry

  3. Extent and intensity of physical activity between pregnancy week 36 and 39

    Time frame: between pregnancy week 36 and 39

    Assessement via accelerometry

Secondary outcomes

  1. Well-being

    Time frame: between pregnancy week 9 and 12

    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.

  2. Well-being

    Time frame: between pregnancy week 23 and 26

    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.

  3. Well-being

    Time frame: between pregnancy week 36 and 39

    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.

  4. Mother-child bond

    Time frame: between pregnancy week 9 and 12

    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.

  5. Mother-child bond

    Time frame: between pregnancy week 23 and 26

    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.

  6. Mother-child bond

    Time frame: between pregnancy week 36 and 39

    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.

  7. Sociodemographics

    Time frame: between pregnancy week 9 and 12

    age, education (</=/> school years), partnership, employment status

  8. Left ventricular muscle mass index

    Time frame: Echocardiography between pregnancy week 9 and 12

    Echocardiography will be done by qualified staff.

  9. Left ventricular muscle mass index

    Time frame: cardiac ultrasound measurement between pregnancy week 23 and 26

    Echocardiography will be done by qualified staff.

  10. Left ventricular muscle mass index

    Time frame: Echocardiography between pregnancy week 36 and 39

    Echocardiography will be done by qualified staff.

  11. Echocardiographic global strain, in %

    Time frame: Echocardiography between pregnancy week 9 and 12

    Echocardiography will be done by qualified staff.

  12. Echocardiographic global strain, in %

    Time frame: cardiac ultrasound measurement between pregnancy week 23 and 26

    The cardiac ultrasound examination will be conduced by qualified staff.

  13. Echocardiographic global strain, in %

    Time frame: Echocardiography between pregnancy week 36 and 39

    Echocardiography will be done by qualified staff.

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Collaborators

  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Registry information

Official study title

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

Acronym: Fit4Two

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 26, 2020
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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