Physical Activity of Pregant WomenENVIFEMNCT04705272
The Role of the Living Environment in the Social Inequalities in the Physical Activities of Pregnant Women Residing in the Eurometropole of Strasbourg
An observational study of Physical Activity of Pregant Women, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Physical Activity of Pregant Women
- What is being tested?
- Questionnaire
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2021to Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Les Hôpitaux Universitaires de Strasbourg
Schiltigheim, 67303
Virginie HAMANN, +33 3 69 55 43 93, virginie.hamann@chru-strasbourg.fr
Virginie HAMANN
About this study
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.
Read more
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:
- 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.
- Conditions
- Physical Activity of Pregant Women
- Being tested
- Questionnaire
- Keywords
- physical activity level, neighborhood,, social inequalities, living environment,, gestational weight gain
- Medical subject headings
- Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 months
Secondary outcomes (1)
Physical activity during each trimester Pregnancy and delivery outcomes
Measuring physical activity in metabolic equivalents in order to see the progress of this activity
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start4 Feb 2021
- Primary completion4 Feb 2021
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical Activity of Pregant WomenStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Virginie HAMANN, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705272
- Sponsor's protocol ID
- 7999
- Acronym
- ENVIFEM
- Status last verified
- Mar 2021
- First submitted
- 5 Oct 2020
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36115665
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Living Environment in the Social Inequalities in the Physical Activities of Pregnant Women Residing in the Eurometropole of Strasbourg
- ClinicalTrials.gov ID
- NCT04705272
- Acronym / sponsor ID
- ENVIFEM / 7999
- Conditions
- Physical Activity of Pregant Women
- Keywords
- physical activity level, neighborhood,, social inequalities, living environment,, gestational weight gain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 4 Feb 2021 (actual)
- Study completion
- Jan 2022 (estimated)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairePregnant 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. | Other | – |
Primary outcome
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
1 secondary outcome
Physical activity during each trimester Pregnancy and delivery outcomes
Time frame: 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Derived from this study: PubMed 36115665Simoncic 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginie HAMANN principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Activity of Pregant Women, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Virginie HAMANN (+33 3 69 55 43 93, virginie.hamann@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GWG gestational weight gain (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04705272, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.