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.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Valentine LHORTOLAT, Midwife
- Telefoonnummer: +33 4 78 86 41 00
- E-mail: valentine.lhortolat@chu-lyon.fr
Studie Contact Back-up
- Naam: Benjamin ROLLAND, MD
- E-mail: Benjamin.rolland@chu-lyon.fr
Studie Locaties
-
-
-
Pierre-Bénite, Frankrijk, 69495
- Service Universitaire d'Addictologie de Lyon - Hôpital Lyon Sud - Hospices Civils de Lyon
-
Contact:
- Valentine LHORTOLAT, Midwife
- Telefoonnummer: +33 4 78 86 41 00
- E-mail: valentine.lhortolat@chu-lyon.fr
-
Hoofdonderzoeker:
- Valentine LHORTOLAT, Midwife
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Women from the general population with regular menstrual cycles.
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: PROSPECTIVE
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Occurrence of an alcohol consumption day
Tijdsspanne: Up to 3 months
|
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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of binge drinking days
Tijdsspanne: Up to 3 months
|
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
|
|
Association between alcohol consumption and anxiety levels over time
Tijdsspanne: Up to 3 months
|
Correlation between average alcohol consumption and anxiety levels assessed using GAD-7 throughout the menstrual cycle. |
Up to 3 months
|
|
Association between alcohol consumption and physical activity over time
Tijdsspanne: Up to 3 months
|
Correlation between average alcohol consumption and physical activity assessed using IPAQ-SF. |
Up to 3 months
|
|
Association between alcohol consumption and sleep quality over time
Tijdsspanne: Up to 3 months
|
Correlation between average alcohol consumption and sleep quality assessed using the Mini Sleep Questionnaire (MSQ) |
Up to 3 months
|
|
Association between alcohol consumption and contraceptive method
Tijdsspanne: Up to 3 months
|
Comparison of alcohol consumption patterns according to contraceptive method used. |
Up to 3 months
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 69HCL26_0226
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .