Physical Activity Level During Pregnancy (Fit4Two)

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Well-being
• Intervention / Treatment: Device: Accelerometry

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 Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Germany
  • Greifswald, Germany, 17475
    • University Medicine Greifswald

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Convenience Sample (female only)

Description

Inclusion Criteria:

- current pregnancy, until pregnancy week 23

Exclusion Criteria:

• cognitive impairment
• insufficient language skills

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Medicine Greifswald
• Collaborators: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
• Investigators: Principal Investigator: Sabina Ulbricht, Prof., University Medicine Greifswald, Dep.Social Medicine and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2020
• Primary Completion (Actual): May 30, 2022
• Study Completion (Actual): May 30, 2022

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (Actual): August 26, 2020

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Pregnancy; Physical activity; Accelerometry
• Other Study ID Numbers: BB002/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No