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

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Houria E. L. Ouazzani ◽  
Steeve Rouillon ◽  
Nicolas Venisse ◽  
Lynda Sifer-Rivière ◽  
Antoine Dupuis ◽  
...  
Keyword(s):  
Health Education ◽  
Environmental Health ◽  
Controlled Trial ◽  
Intervention Group ◽  
Information Leaflet ◽  
Randomized Controlled ◽  
Link Type ◽  
Health Education Intervention ◽  
Exposure During Pregnancy ◽  
Environmental Health Education

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.

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

2021 ◽  
Author(s):  
Houria EL OUAZZANI ◽  
Steeve ROUILLON ◽  
Nicolas VENISSE ◽  
Lynda SIFER-RIVIERE ◽  
Antoine DUPUIS ◽  
...  
Keyword(s):  
Health Education ◽  
Environmental Health ◽  
Controlled Trial ◽  
Intervention Group ◽  
Location Information ◽  
Information Leaflet ◽  
Randomized Controlled ◽  
Health Education Intervention ◽  
Exposure During Pregnancy ◽  
Environmental Health Education

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 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

scholarly journals Perinatal Environmental Health Education Intervention to Reduce Exposure to Endocrine Disruptors: The PREVED Project

2021 ◽  
Author(s):  
HOURIA EL OUAZZANI ◽  
Simon Fortin ◽  
Nicolas Venisse ◽  
Antoine Dupuis ◽  
Steeve Rouillon ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Risk Perception ◽  
Environmental Health ◽  
Endocrine Disruptors ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Canned Food ◽  
Randomized Controlled ◽  
Environmental Health Education

Abstract BackgroundEnvironmental health promotion interventions may reduce endocrine disruptor (ED) exposure. PREVED (PREgnancy, preVention, Endocrine Disruptors) project was developed to improve knowledge, to enhance risk perception and to change exposure behavior. Our objective was to present the phases of PREVED project using the RE-AIM method.MethodsPREVED intervention consisted of 3 workshops during pregnancy. Reach, adoption, and implementation phases were assessed with qualitative studies. Efficacy study consisted of a three-arm randomized controlled trial (RCT) on 268 pregnant women: i) control group (leaflet) ii) intervention group in neutral location iii) intervention group in contextualized location. The main outcome was the percentage evolution of participants who reported consuming canned food. Secondary outcomes were evolution of psycho-social scores, evolution of ED presence in urine and ED presence in colostrum. ResultsThe intervention adoption was centered on upper-privileged women, but implementation assessment showed that key features (highly practical intervention) seemed to be carried out and had initiated some behavior changes. A total of 268 pregnant women participated in the intervention and 230 on randomized controlled trial (control group: 86 and intervention groups: 172). We found no significant differences in consumption of canned food and in percentage of women having a decrease of bisphenol A or parabens in urine, but we found significant increase in the evolution of risk perception score and overall psychosocial score in intervention groups (respectively: +15.73 control versus +21.03 intervention, p=0.003 and +12.39 versus +16.20, p=0.02). We found a significant difference in percentage of women with butylparaben detection between control group and intervention groups (13% versus 3%, p=0.03). ConclusionPREVED intervention is the first intervention research dedicated to perinatal environmental health education in France. By sharing know-how/experience in a positive non-alarmist approach, it improved risk perception, which is a key to behavior change aiming to reduce perinatal ED exposure. Including women in precarious situations stay a major issue.Trial registration number: Retrospectively registered on 31 July 2017 (when the first participant was enrolled in this non-drug intervention, ClinicalTrials.gov was centered in therapeutic trials): NCT03233984 - URL: https://clinicaltrials.gov/ct2/show/NCT03233984

scholarly journals Perinatal Environmental Health Education Intervention to Reduce Exposure to Endocrine Disruptors: The PREVED Project

2021 ◽  
Vol 19 (1) ◽  
pp. 70
Author(s):  
Houria El Ouazzani ◽  
Simon Fortin ◽  
Nicolas Venisse ◽  
Antoine Dupuis ◽  
Steeve Rouillon ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Risk Perception ◽  
Environmental Health ◽  
Endocrine Disruptors ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Canned Food ◽  
Randomized Controlled ◽  
Environmental Health Education

Environmental health promotion interventions may reduce endocrine disruptor (ED) exposure. The PREVED (PREgnancy, preVention, Endocrine Disruptors) project was developed to improve knowledge, to enhance risk perception, and to change exposure behavior. Our objective was to present the phases of the PREVED project using the RE-AIM method. PREVED intervention consisted of three workshops during pregnancy. Reach, adoption, and implementation phases were assessed with qualitative studies. Efficacy study consisted of a three-arm randomized controlled trial (RCT) on 268 pregnant women: (i) control group (leaflet), (ii) intervention group in neutral location, (iii) intervention group in contextualized location. The main outcome was the percentage evolution of participants who reported consuming canned food. Secondary outcomes were evolution of psycho-social scores, evolution of ED presence in urine, and ED presence in colostrum. The intervention adoption was centered on upper-privileged women, but implementation assessment showed that key features (highly practical intervention) seemed to be carried out and had initiated some behavior changes. A total of 268 pregnant women participated in the intervention and 230 in a randomized controlled trial (control group: 86 and intervention groups: 172). We found no significant differences in consumption of canned food and in percentage of women having a decrease of bisphenol A or parabens in urine, but we found a significant increase in the evolution of risk perception score and overall psychosocial score in intervention groups (respectively: +15.73 control versus +21.03 intervention, p = 0.003 and +12.39 versus +16.20, p = 0.02). We found a significant difference in percentage of women with butylparaben detection between control group and intervention groups (13% versus 3%, p = 0.03). PREVED intervention is the first intervention research dedicated to perinatal environmental health education in France. By sharing know-how/experience in a positive non-alarmist approach, it improved risk perception, which is key to behavior change, aiming to reduce perinatal ED exposure. Including women in precarious situations remains a major issue.

Oral Health Education Intervention among Preschoolers: A Randomized Controlled Trial

2019 ◽  
Vol 10 (9) ◽  
pp. 363
Author(s):  
Thara Chandran ◽  
Nagashree Savanur Ravindranath ◽  
Deesha Kumari ◽  
Nagaland Tirupati ◽  
K Mithun ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Oral Health ◽  
Health Education ◽  
Controlled Trial ◽  
Education Intervention ◽  
Oral Health Education ◽  
Randomized Controlled ◽  
Health Education Intervention

scholarly journals Health Education Through a Campaign and mHealth to Enhance Knowledge and Quality of Life Among Patients With Chronic Kidney Disease in Bangladesh: Protocol for a Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Mohammad Habibur Rahman Sarker ◽  
Michiko Moriyama ◽  
Harun Ur Rashid ◽  
Md Moshiur Rahman ◽  
Mohammod Jobayer Chisti ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Kidney Disease ◽  
Randomized Controlled Trial ◽  
Kidney Disease ◽  
Health Education ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled

BACKGROUND Despite the growing burden of chronic kidney disease (CKD), disease knowledge and understanding are still lacking, especially in Bangladesh. OBJECTIVE The aim of this study was to evaluate the outcome of a health education intervention in order to enhance knowledge, health-related quality of life (QOL), and motivation regarding healthy lifestyles among rural and periurban adults suffering from CKD. METHODS A parallel-group (1:1) randomized controlled trial is ongoing in the Mirzapur subdistrict, Bangladesh, where two groups of patients with CKD are being compared. Patients aged 18 years and over with CKD (stages 1-3) were enrolled in November 2020. Patients were randomly allocated into either the intervention group (n=63) or the control group (n=63). The control group received usual treatment, while the intervention group received health education through a CKD campaign facilitated by a nephrologist and via mHealth (ie, periodic mobile phone calls) from community health workers. Both groups were followed up for a period of 6 months. The primary endpoint is patients’ increased knowledge measured using the Chronic Kidney Disease Knowledge Questionnaire. The secondary endpoints are improved QOL measured using the standardized EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire as well as improvements in the levels of blood pressure, BMI, serum creatinine, fasting blood sugar, hemoglobin, cholesterol, high-density lipoprotein cholesterol, triglyceride, serum uric acid, blood urea nitrogen, and albumin to creatinine ratio. RESULTS Enrollment of participants began in November 2020; the intervention and follow-up were completed in May 2021. We enrolled 126 patients in the study. Patients’ mean ages were 57.97 (SD 15.03) years in the control group and 57.32 (SD 14.37) years in the intervention group. There were 45 out of 63 (71%) females in the control group and 38 out of 63 (60%) females in the intervention group. In addition, there were 38 out of 63 (60%) literate patients in the control group and 33 out of 63 (52%) literate patients in the intervention group. CONCLUSIONS It is expected that a combined approach, incorporating both a CKD campaign and mHealth, for health education may be an effective tool for increasing knowledge and improving QOL among patients with CKD. CLINICALTRIAL ClinicalTrials.gov NCT04094831; https://clinicaltrials.gov/ct2/show/NCT04094831 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/30191

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