Reducing Endocrine-Disrupting Chemical Exposure in Reproductive-Age Women: A Pender Model-Based RCT

NCT07773233 | Not Yet Recruiting

• 1 other identifier: HarranUU
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Women Who Are Aged 18-49 Years; Able to Read, Write; Voluntarily Agree to Participate in the Study

Keywords

endocrine-disrupting chemicals; bisphenol A; Pender's Health Promotion Model; behavioral change; phthalates

Outcome Measures

Primary Outcomes (1)

• Analysis of Bisphenol A (BPA) and Phthalate Metabolite Levels in Urine Samples

  12-week

Study Arms (2)

control group

NO INTERVENTION

intervention group

OTHER

Other: Intervention Group

Interventions

Intervention Group OTHER

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.

intervention group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harran University: lead

Central Study Contacts

Fatma Aslan

CONTACT

05427760715; fatmaaslan62@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 19, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share