NCT04705272

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 5, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
23 days until next milestone

Study Start

First participant enrolled

February 4, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

Same day

First QC Date

October 5, 2020

Last Update Submit

March 29, 2021

Conditions

Keywords

physical activity levelneighborhood,social inequalitiesliving environment,gestational weight gain

Outcome Measures

Primary Outcomes (1)

  • GWG gestational weight gain

    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 Outcomes (1)

  • Physical activity during each trimester Pregnancy and delivery outcomes

    7 months

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Les Hôpitaux Universitaires de Strasbourg

Schiltigheim, 67303, France

RECRUITING

Related Publications (1)

  • Simoncic V, Hamann V, Huber L, Deruelle P, Sananes N, Enaux C, Alter M, Schillinger C, Deguen S, Kihal-Talantikite W. Study protocol to explore the social effects of environmental exposure and lifestyle behaviours on pregnancy outcome: an overview of cohort of pregnant women study. BMJ Open. 2022 Sep 17;12(9):e058883. doi: 10.1136/bmjopen-2021-058883.

MeSH Terms

Conditions

Gestational Weight Gain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Weight GainBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Virginie HAMANN

    Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

October 5, 2020

First Posted

January 12, 2021

Study Start

February 4, 2021

Primary Completion

February 4, 2021

Study Completion

January 1, 2022

Last Updated

April 1, 2021

Record last verified: 2021-03

Locations