NCT04527731

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 26, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

2.3 years

First QC Date

June 17, 2020

Last Update Submit

December 7, 2023

Conditions

Physical ActivityWell-being

Keywords

PregnancyPhysical activityAccelerometry

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (13)

  • Well-being

    between pregnancy week 9 and 12

  • Well-being

    between pregnancy week 23 and 26

  • Well-being

    between pregnancy week 36 and 39

  • Mother-child bond

    between pregnancy week 9 and 12

  • Mother-child bond

    between pregnancy week 23 and 26

  • +8 more secondary outcomes

Interventions

AccelerometryDEVICE

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Convenience Sample (female only)

You may qualify if:

  • \- current pregnancy, until pregnancy week 23

You may not qualify if:

  • cognitive impairment
  • insufficient language skills

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medicine Greifswald

Greifswald, 17475, Germany

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Accelerometry

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Sabina Ulbricht, Prof.

    University Medicine Greifswald, Dep.Social Medicine and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2020

First Posted

August 26, 2020

Study Start

February 25, 2020

Primary Completion

May 30, 2022

Study Completion

May 30, 2022

Last Updated

December 8, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)