Impact of perinatal environmental health education intervention on exposure to endocrine disruptors during pregnancy - PREVED study: study protocol for a randomized controlled trial
التفاصيل البيبلوغرافية
العنوان:
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 apply 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: 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 number 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 centred in therapeutic trials. World Health Organization Trial Registration Data Set: Additional file 1
