Trials (Dec 2021)

Impact of perinatal environmental health education intervention on exposure to endocrine disruptors during pregnancy—PREVED study: study protocol for a randomized controlled trial

  • Houria E. L. Ouazzani,
  • Steeve Rouillon,
  • Nicolas Venisse,
  • Lynda Sifer-Rivière,
  • Antoine Dupuis,
  • Guillaume Cambien,
  • Sarah Ayraud-Thevenot,
  • Anne-Sophie Gourgues,
  • Pascale Pierre-Eugène,
  • Fabrice Pierre,
  • Sylvie Rabouan,
  • DisProSE Group,
  • Virginie Migeot,
  • Marion Albouy-Llaty

DOI
https://doi.org/10.1186/s13063-021-05813-5
Journal volume & issue
Vol. 22, no. 1
pp. 1 – 12

Abstract

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Abstract 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.

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