ClinicalTrials.gg
Not yet recruitingNCT07773233Updated Aug 19, 2026

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

An interventional study of Intervention Group in Women Who Are Aged 18-49 Years, Able to Read, Write and Voluntarily Agree to Participate in the Study, sponsored by Harran University. Not yet recruiting. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Harran University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • 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
03

In context

Lead sponsor

Harran University is the lead sponsor of 63 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
108 participants (estimated)

Study arms

  • No intervention
    control group
  • Other
    intervention group

    Other: Intervention Group

Interventions

  • OtherIntervention 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.

06

What researchers measure

Primary outcomes

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

    Time frame: 12-week

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2026; primary completion for Dec 2027, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 14, 2026
First posted
Aug 19, 2026
StartEst.
Dec 1, 2026
Primary completionEst.
Dec 1, 2027
CompletionEst.
Dec 30, 2027
Last update
Aug 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07773233
Lead sponsor
Harran University
Responsible party
Fatma Aslan (PhD, Harran University) — Principal investigator
First posted
Aug 19, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Dec 1, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Aug 19, 2026

Study contacts

Fatma Aslan
Contact
fatmaaslan62@gmail.com
05427760715

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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