- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07773233
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.
연구 개요
상태
개입 / 치료
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Fatma Aslan
- 전화번호: 05427760715
- 이메일: fatmaaslan62@gmail.com
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 대조군
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다른: 개입 그룹
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Analysis of Bisphenol A (BPA) and Phthalate Metabolite Levels in Urine Samples
기간: 12-week
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12-week
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- HarranUU
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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