Reducing Endocrine-Disrupting Chemical Exposure in Reproductive-Age Women: A Pender Model-Based RCT
Effectiveness of a Pender's Health Promotion Model-Based Behavioral Change Intervention to Reduce Exposure to Endocrine-Disrupting Chemicals in Women of Reproductive Age: A Biomarker-Supported Randomized Controlled Trial
Abstract
Background: Endocrine-disrupting chemicals (EDCs) are widely encountered in daily life and may adversely affect reproductive health. Although awareness of EDC-related risks is increasing, interventions targeting modifiable exposure-related behaviors remain limited. Theory-based behavioral interventions that address self-efficacy, perceived barriers, action planning, and maintenance of health-promoting behaviors may provide an effective approach to reducing EDC exposure.
Objective: This study aims to evaluate the effectiveness of a behavioral change intervention based on Pender's Health Promotion Model in reducing EDC exposure among women of reproductive age using both behavioral outcomes and urinary biomarkers.
Methods: This study is designed as a biomarker-supported, two-arm, parallel-group, open-label randomized controlled trial. A total of 108 women aged 18-49 years will be randomly allocated in a 1:1 ratio to an intervention or control group. The intervention group will participate in a 12-week structured behavioral change program based on Pender's Health Promotion Model. The program will include education, goal setting, action planning, self-monitoring, problem solving, social support, behavioral rehearsal, environmental restructuring, and digital reinforcement messages delivered via WhatsApp. EDC-related exposure behaviors, exposure perception, and attitudes will be assessed using structured measurement tools. Urinary bisphenol A (BPA) and selected phthalate metabolites will be measured before and after the intervention using liquid chromatography-tandem mass spectrometry. The primary outcome will be the between-group difference in post-intervention urinary BPA levels adjusted for baseline BPA. Secondary outcomes will include urinary phthalate metabolites, exposure-related behaviors, exposure perception, and attitudes toward EDCs.
Conclusion: This study will provide evidence on whether a theory-based behavioral change intervention can reduce EDC exposure at both behavioral and biological levels. Integrating Pender's Health Promotion Model with objective biomarker assessment may contribute to the development of feasible and evidence-based strategies for reducing EDC exposure among women of reproductive age.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Fatma Aslan
- Numéro de téléphone: 05427760715
- E-mail: fatmaaslan62@gmail.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- A total of 108 women aged 18-49 years will be randomly allocated in a 1:1 ratio to an intervention or control group. The intervention group will participate in a 12-week structured behavioral change program based on Pender's Health Promotion Model. The program will include education, goal setting, action planning, self-monitoring, problem solving, social support, behavioral rehearsal, environmental restructuring, and digital reinforcement messages delivered via WhatsApp
Exclusion Criteria:
- At the beginning of the study, women who are pregnant or breastfeeding, menopausal, have cognitive or psychiatric disorders severe enough to interfere with active participation in the study or independent completion of the data collection instruments, have a diagnosed serious endocrine disorder that could significantly affect the endocrine system (e.g., pituitary disorders or Cushing's syndrome), or have participated in a structured educational program on endocrine-disrupting chemicals within the previous six months will be excluded from the study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune intervention: groupe de contrôle
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Autre: groupe d'intervention
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The intervention group will participate in a 12-week structured behavioral change program based on Pender's Health Promotion Model.
The program will include education, goal setting, action planning, self-monitoring, problem solving, social support, behavioral rehearsal, environmental restructuring, and digital reinforcement messages delivered via WhatsApp.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Analysis of Bisphenol A (BPA) and Phthalate Metabolite Levels in Urine Samples
Délai: 12-week
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12-week
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- HarranUU
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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