Abstract
BackgroundThe 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/designPREVED (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.DiscussionPREVED 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 registrationClinicalTrials.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.
Highlights
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
Prenatal exposure can disturb fetal and neonatal development [1] and lead to numerous disorders [2,3,4]. These health consequences are especially underlined by FOAD- (Fetal Origins of Adult Disease) [5], DOHaD- (Developmental Origins of Health and Disease) theories [6, 7], which emphasize the importance of intrauterine environmental exposure in offspring health, and by POHaD-theory (Paternal Origins of Health and Disease), which underlines the role of paternal environment and exposure [8]
Given the methodological difficulties in proving EDC’s effects in humans, some authors are convinced that it is impossible to conclusively demonstrate, and they would rather think in terms of prevention actions
Summary
PREVED is the first study to assess the impact of perinatal environmental health education by promoting the sharing of know-how and experience in a positive and non-alarmist approach. Intervention research applied to the health field is a specific kind of research that aims to provide information on the impact of interventions on population health using scientific methods [63] and to determine how “to intervene” (not “to discover”) [64] This design should be well-founded and include partnerships with practitioners [65]. Previous studies assessed the impact by taking into account only one component of lifestyle, such as nutrition or cosmetics [67, 68] and did not include the dimension of “know-how” [69] These studies took EDC concentrations in urine as their main outcome, even though analysis of the latter may be unreliable [70,71,72] and did not provide information about psychosocial aspects. At the time of the analysis, results will be adjusted on confounding factors that affect the psycho-social dimensions and have been highlighted in this study
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