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.
Descripción general del estudio
Estado
Descripción detallada
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).
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Valentine LHORTOLAT, Midwife
- Número de teléfono: +33 4 78 86 41 00
- Correo electrónico: valentine.lhortolat@chu-lyon.fr
Copia de seguridad de contactos de estudio
- Nombre: Benjamin ROLLAND, MD
- Correo electrónico: Benjamin.rolland@chu-lyon.fr
Ubicaciones de estudio
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Pierre-Bénite, Francia, 69495
- Service Universitaire d'Addictologie de Lyon - Hôpital Lyon Sud - Hospices Civils de Lyon
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Contacto:
- Valentine LHORTOLAT, Midwife
- Número de teléfono: +33 4 78 86 41 00
- Correo electrónico: valentine.lhortolat@chu-lyon.fr
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Investigador principal:
- Valentine LHORTOLAT, Midwife
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Women from the general population with regular menstrual cycles.
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Occurrence of an alcohol consumption day
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of binge drinking days
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 69HCL26_0226
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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