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Impact of perinatal environmental health education intervention on exposure to endocrine disruptors during pregnancy—PREVED study: study protocol for a randomized controlled trial
BACKGROUND: The suspected or actual effects on health of endocrine-disrupting chemicals (EDC) and their ubiquitous presence in everyday life justify the implementation of health promotion interventions. These interventions should ideally be applied during critical windows like pregnancy. Perinatal e...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8642981/ https://www.ncbi.nlm.nih.gov/pubmed/34863252 http://dx.doi.org/10.1186/s13063-021-05813-5 |
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author | Ouazzani, Houria El. Rouillon, Steeve Venisse, Nicolas Sifer-Rivière, Lynda Dupuis, Antoine Cambien, Guillaume Ayraud-Thevenot, Sarah Gourgues, Anne-Sophie Pierre-Eugène, Pascale Pierre, Fabrice Rabouan, Sylvie Migeot, Virginie Albouy-Llaty, Marion |
author_facet | Ouazzani, Houria El. Rouillon, Steeve Venisse, Nicolas Sifer-Rivière, Lynda Dupuis, Antoine Cambien, Guillaume Ayraud-Thevenot, Sarah Gourgues, Anne-Sophie Pierre-Eugène, Pascale Pierre, Fabrice Rabouan, Sylvie Migeot, Virginie Albouy-Llaty, Marion |
author_sort | Ouazzani, Houria El. |
collection | PubMed |
description | BACKGROUND: The suspected or actual effects on health of endocrine-disrupting chemicals (EDC) and their ubiquitous presence in everyday life justify the implementation of health promotion interventions. These interventions should ideally be applied during critical windows like pregnancy. Perinatal environmental health education interventions may help to reduce EDC exposure during pregnancy. METHODS/DESIGN: PREVED (Pregnancy, PreVention, Endocrine Disruptors) is an open-label randomized controlled trial assessing the impact of environmental health education intervention on EDC exposure during pregnancy. Inclusion, consent, and randomization take place during the first trimester. The participants are randomly allocated into three groups: (i) control group (information leaflet on EDCs), (ii) intervention group in neutral location (information leaflet and workshops in a meeting room), and (iii) intervention group in contextualized location (information leaflet and workshops in a real apartment). Workshops are organized between the second and third trimesters of pregnancy. Main outcome is the percentage of participants who reported consuming manufactured/industrial food. Secondary outcomes are as follows: (i) psycho-social dimensions, (ii) EDC concentrations in urine, (iii) EDC concentration in colostrum, and (iv) percentage of participants who reported consuming paraben-free personal care products. DISCUSSION: PREVED is a ground-breaking intervention research project dedicated to perinatal environmental health education that aims to identify pollutant sources in daily life and to offer accessible and realistic alternative solutions, by promoting the sharing of know-how and experience in a positive and non-alarmist approach. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03233984 (current status: ongoing). Retrospectively registered on 31 July 2017 (https://clinicaltrials.gov/ct2/show/NCT03233984) because when the first participant was enrolled in this non-drug intervention, ClinicalTrials.gov was centered in therapeutic trials. The World Health Organization Trial Registration Data Set is in Additional file 1. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05813-5. |
format | Online Article Text |
id | pubmed-8642981 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-86429812021-12-06 Impact of perinatal environmental health education intervention on exposure to endocrine disruptors during pregnancy—PREVED study: study protocol for a randomized controlled trial Ouazzani, Houria El. Rouillon, Steeve Venisse, Nicolas Sifer-Rivière, Lynda Dupuis, Antoine Cambien, Guillaume Ayraud-Thevenot, Sarah Gourgues, Anne-Sophie Pierre-Eugène, Pascale Pierre, Fabrice Rabouan, Sylvie Migeot, Virginie Albouy-Llaty, Marion Trials Study Protocol BACKGROUND: The suspected or actual effects on health of endocrine-disrupting chemicals (EDC) and their ubiquitous presence in everyday life justify the implementation of health promotion interventions. These interventions should ideally be applied during critical windows like pregnancy. Perinatal environmental health education interventions may help to reduce EDC exposure during pregnancy. METHODS/DESIGN: PREVED (Pregnancy, PreVention, Endocrine Disruptors) is an open-label randomized controlled trial assessing the impact of environmental health education intervention on EDC exposure during pregnancy. Inclusion, consent, and randomization take place during the first trimester. The participants are randomly allocated into three groups: (i) control group (information leaflet on EDCs), (ii) intervention group in neutral location (information leaflet and workshops in a meeting room), and (iii) intervention group in contextualized location (information leaflet and workshops in a real apartment). Workshops are organized between the second and third trimesters of pregnancy. Main outcome is the percentage of participants who reported consuming manufactured/industrial food. Secondary outcomes are as follows: (i) psycho-social dimensions, (ii) EDC concentrations in urine, (iii) EDC concentration in colostrum, and (iv) percentage of participants who reported consuming paraben-free personal care products. DISCUSSION: PREVED is a ground-breaking intervention research project dedicated to perinatal environmental health education that aims to identify pollutant sources in daily life and to offer accessible and realistic alternative solutions, by promoting the sharing of know-how and experience in a positive and non-alarmist approach. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03233984 (current status: ongoing). Retrospectively registered on 31 July 2017 (https://clinicaltrials.gov/ct2/show/NCT03233984) because when the first participant was enrolled in this non-drug intervention, ClinicalTrials.gov was centered in therapeutic trials. The World Health Organization Trial Registration Data Set is in Additional file 1. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05813-5. BioMed Central 2021-12-04 /pmc/articles/PMC8642981/ /pubmed/34863252 http://dx.doi.org/10.1186/s13063-021-05813-5 Text en © The Author(s) 2021, corrected publication 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Ouazzani, Houria El. Rouillon, Steeve Venisse, Nicolas Sifer-Rivière, Lynda Dupuis, Antoine Cambien, Guillaume Ayraud-Thevenot, Sarah Gourgues, Anne-Sophie Pierre-Eugène, Pascale Pierre, Fabrice Rabouan, Sylvie Migeot, Virginie Albouy-Llaty, Marion Impact of perinatal environmental health education intervention on exposure to endocrine disruptors during pregnancy—PREVED study: study protocol for a randomized controlled trial |
title | Impact of perinatal environmental health education intervention on exposure to endocrine disruptors during pregnancy—PREVED study: study protocol for a randomized controlled trial |
title_full | Impact of perinatal environmental health education intervention on exposure to endocrine disruptors during pregnancy—PREVED study: study protocol for a randomized controlled trial |
title_fullStr | Impact of perinatal environmental health education intervention on exposure to endocrine disruptors during pregnancy—PREVED study: study protocol for a randomized controlled trial |
title_full_unstemmed | Impact of perinatal environmental health education intervention on exposure to endocrine disruptors during pregnancy—PREVED study: study protocol for a randomized controlled trial |
title_short | Impact of perinatal environmental health education intervention on exposure to endocrine disruptors during pregnancy—PREVED study: study protocol for a randomized controlled trial |
title_sort | impact of perinatal environmental health education intervention on exposure to endocrine disruptors during pregnancy—preved study: study protocol for a randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8642981/ https://www.ncbi.nlm.nih.gov/pubmed/34863252 http://dx.doi.org/10.1186/s13063-021-05813-5 |
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