- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07910643
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women (FLOW)
Influence of the Menstrual Cycle on Alcohol Consumption, Anxiety, Physical Activity and Sleep in Women: A Prospective Longitudinal Observational Cohort Study (FLOW)
The FLOW study aims to assess the association between menstrual cycle phases and alcohol consumption in women from the general population. Hormonal fluctuations throughout the menstrual cycle may influence alcohol use behaviors, anxiety levels, physical activity, and sleep quality. Participants will be followed prospectively for three consecutive menstrual cycles through monthly questionnaires assessing alcohol consumption, anxiety, physical activity, and sleep.
연구 개요
상세 설명
Alcohol consumption among women has increased in recent years and represents a major public health concern. Emerging evidence suggests that ovarian hormones may influence vulnerability to substance use and addictive behaviors. The menstrual cycle provides a physiological model to investigate the effects of hormonal fluctuations on alcohol consumption patterns.
FLOW is a prospective, longitudinal, observational cohort study designed to evaluate the relationship between menstrual cycle phases and alcohol consumption in women with regular menstrual cycles. Participants will complete online self-administered questionnaires at baseline (Month 1) and during two subsequent monthly follow-up assessments (Month 2 and Month 3).
Data collected include menstrual cycle characteristics, alcohol use assessed using the Alcohol Timeline Followback (A-TLFB), anxiety symptoms measured by the Generalized Anxiety Disorder-7 scale (GAD-7), physical activity assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF), and sleep quality assessed using the Mini Sleep Questionnaire (MSQ).
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Valentine LHORTOLAT, Midwife
- 전화번호: +33 4 78 86 41 00
- 이메일: valentine.lhortolat@chu-lyon.fr
연구 연락처 백업
- 이름: Benjamin ROLLAND, MD
- 이메일: Benjamin.rolland@chu-lyon.fr
연구 장소
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Pierre-Bénite, 프랑스, 69495
- Service Universitaire d'Addictologie de Lyon - Hôpital Lyon Sud - Hospices Civils de Lyon
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연락하다:
- Valentine LHORTOLAT, Midwife
- 전화번호: +33 4 78 86 41 00
- 이메일: valentine.lhortolat@chu-lyon.fr
-
수석 연구원:
- Valentine LHORTOLAT, Midwife
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Women from the general population with regular menstrual cycles.
설명
Inclusion Criteria:
- Female
- Age between 18 and 45 years
- Regular menstrual cycle lasting between 21 and 37 days
- Able to complete online questionnaires
- Provides informed consent
Exclusion Criteria:
- Postmenopausal women
- Use of medications interfering with menstrual cycle physiology, other than contraception
- Initiation of hormonal contraception within the previous 3 months
- Pregnant women
- Breastfeeding women
- Pregnancy planned within the next 3 month
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Occurrence of an alcohol consumption day
기간: Up to 3 months
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Assessment of whether alcohol was consumed (Yes/No), measured using the Alcohol Timeline Followback (A-TLFB) over the previous 7 days, across three menstrual cycles |
Up to 3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of binge drinking days
기간: Up to 3 months
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Number of days with excessive alcohol consumption during the previous 7 days, assessed using A-TLFB. Excessive alcohol consumption is defined as at least six standard drinks consumed on a given day. |
Up to 3 months
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Association between alcohol consumption and anxiety levels over time
기간: Up to 3 months
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Correlation between average alcohol consumption and anxiety levels assessed using GAD-7 throughout the menstrual cycle. |
Up to 3 months
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Association between alcohol consumption and physical activity over time
기간: Up to 3 months
|
Correlation between average alcohol consumption and physical activity assessed using IPAQ-SF. |
Up to 3 months
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Association between alcohol consumption and sleep quality over time
기간: Up to 3 months
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Correlation between average alcohol consumption and sleep quality assessed using the Mini Sleep Questionnaire (MSQ) |
Up to 3 months
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Association between alcohol consumption and contraceptive method
기간: Up to 3 months
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Comparison of alcohol consumption patterns according to contraceptive method used. |
Up to 3 months
|
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 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .