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.
Studienübersicht
Status
Detaillierte Beschreibung
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).
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Valentine LHORTOLAT, Midwife
- Telefonnummer: +33 4 78 86 41 00
- E-Mail: valentine.lhortolat@chu-lyon.fr
Studieren Sie die Kontaktsicherung
- Name: Benjamin ROLLAND, MD
- E-Mail: Benjamin.rolland@chu-lyon.fr
Studienorte
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Pierre-Bénite, Frankreich, 69495
- Service Universitaire d'Addictologie de Lyon - Hôpital Lyon Sud - Hospices Civils de Lyon
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Kontakt:
- Valentine LHORTOLAT, Midwife
- Telefonnummer: +33 4 78 86 41 00
- E-Mail: valentine.lhortolat@chu-lyon.fr
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Hauptermittler:
- Valentine LHORTOLAT, Midwife
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Women from the general population with regular menstrual cycles.
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Occurrence of an alcohol consumption day
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Number of binge drinking days
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Up to 3 months
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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
Zeitfenster: 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
Zeitfenster: Up to 3 months
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Comparison of alcohol consumption patterns according to contraceptive method used. |
Up to 3 months
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 69HCL26_0226
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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