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.
Studieoversikt
Status
Detaljert beskrivelse
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).
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Valentine LHORTOLAT, Midwife
- Telefonnummer: +33 4 78 86 41 00
- E-post: valentine.lhortolat@chu-lyon.fr
Studer Kontakt Backup
- Navn: Benjamin ROLLAND, MD
- E-post: Benjamin.rolland@chu-lyon.fr
Studiesteder
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Pierre-Bénite, Frankrike, 69495
- Service Universitaire d'Addictologie de Lyon - Hôpital Lyon Sud - Hospices Civils de Lyon
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Ta kontakt med:
- Valentine LHORTOLAT, Midwife
- Telefonnummer: +33 4 78 86 41 00
- E-post: valentine.lhortolat@chu-lyon.fr
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Hovedetterforsker:
- Valentine LHORTOLAT, Midwife
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Women from the general population with regular menstrual cycles.
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Occurrence of an alcohol consumption day
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of binge drinking days
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 3 months
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Comparison of alcohol consumption patterns according to contraceptive method used. |
Up to 3 months
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 69HCL26_0226
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