The Role of the Living Environment in the Social Inequalities in the Physical Activities of Pregnant Women Residing in the Eurometropole of Strasbourg (ENVIFEM)

March 29, 2021 updated by: University Hospital, Strasbourg, France

Excessive weight gain during pregnancy can promote subsequent obesity or increase pre-existing maternal obesity, lead to complications during pregnancy, such as gestational diabetes, hypertension and pre-pregnancy eclampsia, which affect fetal growth.

What are the determinants of excessive weight gain? The first determinant of excessive weight gain is related to healthy living place and physical activity, noted as "PA". Many meta-analyses have demonstrated the role of PA in gestational weight gain.

The main objective is to study the role of the living environment in the PA practice of pregnant women and to identify the socio-environmental construction contributing to the disparities in the practice of PA in women during their pregnancy. This thesis is based on an innovative approach in France, combining both epidemiology and geography approaches to meet priority research objectives in a public health context. With regard to the general issue "What are the contextual determinants of pregnant women's PA practice beyond their individual characteristics that could explain the disparities in practice according to their socio-economic position?" This question underlies the following assumptions:

i) In addition to their individual characteristics, women with low PA and who have reduced PA during pregnancy reside in a more socio-economically deprived neighborhood.

ii)Beyond the socio-economic dimension, the physical characteristic of the residential place influences the level of PA practice of pregnant women.

iii) The combination of the socio-economic, physical and psychosocial environment contributes to reducing the level of PA among pregnant women.

iv) Pregnant women with an unfavourable living environment and low PA have adverse pregnancy outcomes.

Study Overview

Status

Unknown

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Schiltigheim, France, 67303
        • Recruiting
        • Les Hôpitaux Universitaires de Strasbourg
        • Contact:
        • Principal Investigator:
          • Virginie HAMANN
        • Sub-Investigator:
          • Philippe DERUELLE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women will be included in the study at the time of their first or second trimester ultrasound in the Hautepierre and CMCO ultrasound department. The period of inclusion should extend from 1 October 2020 to 31 October 2021 with a duration of participation of each subject of 9 months.

Description

Inclusion Criteria:

  • Pregnant women living in the Strasbourg Eurometropolis
  • Women performing ultrasound follow-up and giving birth in HUS
  • Understanding of the French language
  • Patient who has expressed no opposition to the research and/or has signed a consent form in case of collection creation

Exclusion Criteria:

  • Refusal to participate in study
  • Minor women
  • Unable to provide informed information (subject in an emergency, difficulty understanding the subject, etc.)
  • Subject under protection of justice
  • Subject under guardianship or curatorship
  • Obstetric pathologies against-indicating the practice of AP

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GWG gestational weight gain
Time Frame: 7 months
Calculation of the difference in weight at the beginning of pregnancy and at the end of pregnancy based on medical and declarative data
7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity during each trimester Pregnancy and delivery outcomes
Time Frame: 7 months
Measuring physical activity in metabolic equivalents in order to see the progress of this activity
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Virginie HAMANN, Hopitaux Universitaires de Strasbourg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2021

Primary Completion (Actual)

February 4, 2021

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

October 5, 2020

First Submitted That Met QC Criteria

January 11, 2021

First Posted (Actual)

January 12, 2021

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 29, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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