Women Who Are Aged 18-49 YearsNCT07773233
Reducing Endocrine-Disrupting Chemical Exposure in Reproductive-Age Women: A Pender Model-Based RCT
A study testing Intervention Group in people with Women Who Are Aged 18-49 Years and Able to Read, Write, run by Harran University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women Who Are Aged 18-49 Years, Able to Read, Write, Voluntarily Agree to Participate in the Study
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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
- Being tested
- Intervention Group
- Keywords
- endocrine-disrupting chemicals, bisphenol A, Pender's Health Promotion Model, behavioral change, phthalates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Not described |
| intervention group | Other | Not described Receives: Other: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of Bisphenol A (BPA) and Phthalate Metabolite Levels in Urine Samples
Measured: 12-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women Who Are Aged 18-49 YearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Aslan, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773233
- Sponsor's protocol ID
- HarranUU
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07773233
- Acronym / sponsor ID
- HarranUU
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | – |
| intervention group | Other | Other: Intervention Group |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention GroupThe 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. | Other | intervention group |
Primary outcome
Analysis of Bisphenol A (BPA) and Phthalate Metabolite Levels in Urine Samples
Time frame: 12-week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Women Who Are Aged 18-49 Years and Able to Read, Write, run by Harran University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma Aslan (05427760715, fatmaaslan62@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of Bisphenol A (BPA) and Phthalate Metabolite Levels in Urine Samples (time frame: 12-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.