Clinical trial NCT04527731: Physical Activity Level During Pregnancy
Official title: Fit for Two - A Pilot Study on Physical Activity Levels During Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Activity
Well-being
Keywords: Pregnancy
Physical activity
Accelerometry
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
Collaborators: name: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
First posted: 2020-08-26
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Convenience Sample (female only)

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

- current pregnancy, until pregnancy week 23

Exclusion Criteria:

* cognitive impairment
* insufficient language skills

Primary outcomes:
measure: Extent and intensity of physical activity between pregnancy week 9 and 12
timeFrame: between pregnancy week 9 and 12
measure: Extent and intensity of physical activity between pregnancy week 23 and 26
timeFrame: between pregnancy week 23 and 26
measure: Extent and intensity of physical activity between pregnancy week 36 and 39
timeFrame: between pregnancy week 36 and 39
Secondary outcomes:
measure: Well-being
timeFrame: between pregnancy week 9 and 12
measure: Well-being
timeFrame: between pregnancy week 23 and 26
measure: Well-being
timeFrame: between pregnancy week 36 and 39
measure: Mother-child bond
timeFrame: between pregnancy week 9 and 12
measure: Mother-child bond
timeFrame: between pregnancy week 23 and 26
measure: Mother-child bond
timeFrame: between pregnancy week 36 and 39
measure: Sociodemographics
timeFrame: between pregnancy week 9 and 12
measure: Left ventricular muscle mass index
timeFrame: Echocardiography between pregnancy week 9 and 12
measure: Left ventricular muscle mass index
timeFrame: cardiac ultrasound measurement between pregnancy week 23 and 26
measure: Left ventricular muscle mass index
timeFrame: Echocardiography between pregnancy week 36 and 39
measure: Echocardiographic global strain, in %
timeFrame: Echocardiography between pregnancy week 9 and 12
measure: Echocardiographic global strain, in %
timeFrame: cardiac ultrasound measurement between pregnancy week 23 and 26
measure: Echocardiographic global strain, in %
timeFrame: Echocardiography between pregnancy week 36 and 39
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University Medicine Greifswald
Study officials:
affiliation: University Medicine Greifswald, Dep.Social Medicine and Prevention
name: Sabina Ulbricht, Prof.
role: PRINCIPAL_INVESTIGATOR
References: