- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07678853
Mental and Physical Well-being and School Absence Among School Children Using Nicotine Pouches Compared to Their Peers
This cross-sectional study investigates whether the use of nicotine pouches is associated with poorer mental and physical well-being and increased school absence among Danish adolescents.
The study population comprises 13-18-year-old students from public schools in Aarhus Municipality, Denmark, who completed two school-based questionnaires between September 2020 and June 2022: (1) the Aarhus Municipality Questionnaire (AMQ), including items on nicotine use, and (2) the Danish National Well-being Questionnaire (DNWQ), a 40-item instrument assessing different domains of school-related well-being. Questionnaire data are linked at the individual level to national administrative registers via the Danish Civil Registration System.
Exposure is defined as current use of nicotine pouches based on AMQ responses. Adolescents who report using "snus" (slang for nicotine pouches) "not every day, but every week" or "every day" are classified as nicotine pouch users. Non-exposed adolescents are those who report no use or less than weekly use; individuals who choose "I do not wish to answer" are categorized as "undisclosed" and excluded from primary analyses.
The primary outcomes are: (1) a composite mental and physical well-being score derived from 10 DNWQ items (Likert scales recoded to a 1-5 range, summed to a total score from 10 to 50) and (2) days of school absence (overall, and by illegal vs. sickness-related absence) obtained from national education registers. Secondary outcomes include item-level response patterns for the 10 DNWQ items and subgroup analyses of the association between nicotine pouch use and well-being across strata of socioeconomic status, age, sex, origin, and mental illness in the adolescent or their caregivers.
Covariates are drawn from questionnaires and national registers and include age, sex, e-cigarette and cigarette use, family structure, household education, household income, immigration status, and psychiatric diagnoses in the adolescent and household providers.
Descriptive statistics will compare baseline characteristics between nicotine pouch users and non-users. Primary analyses will apply linear mixed-effects models for the continuous well-being score and generalized linear mixed models with log link (Poisson or negative binomial) for counts of school absence, with and without adjustment for key confounders (age, sex, household education, household income, origin). Missing covariate data will be addressed using multiple imputation by chained equations under a missing-at-random assumption. Effect modification will be explored by stratified analyses and interaction terms.
The study will provide novel, population-based evidence on the potential mental, physical, and educational consequences of nicotine pouch use among adolescents, informing clinicians, public health professionals, and policymaker
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Kolding, Dinamarca, 6000
- Department of Pediactrics, Sygehus Lillebælt
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Answered all questions regarding usage of nicotine (AMQ) AND
- Answered questions regarding mental and physical well-being in DNWQ AND/OR
- Available data on school absence
Exclusion Criteria:
- Student in a special needs class or reception class for newcomers
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
Control S
|
|
Nicotine pouch users
|
|
Undisclosed use of nicotine pouches
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Days of illegal school absence and due to sickness
Periodo de tiempo: During school year 2020/2021 and/or 2021/2022
|
During school year 2020/2021 and/or 2021/2022
|
|
|
Mental and physical well-being score
Periodo de tiempo: During school hours in school year 2020/2021 and/or 2021/2022
|
Mental and physical well-being score are defined per design by ten questions in the Danish National Well-being Questionaire with answer possibilities 1 - 5 (Likert scale) and with one question ranging from 1 - 4. All data has already been processed by Statistics Denmark, thus questions phrased negatively have been inverted and the question ranging from 1 - 4 has been recalculated fitting a 1 - 5 scale.
The cumulative score ranging from 10 to 50 now depicts the adolescent's mental and physical well-being from low to high corresponding to the numeric value.
A corrected value will be calculated for all adolescents who answered 1 to 9 questions on the questionnaire.
|
During school hours in school year 2020/2021 and/or 2021/2022
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Group differences in response patterns of each of the 10 items for physical and mental well-being score
Periodo de tiempo: During school year 2020/2021 and/or 2021/2022
|
Mental and physical well-being score are defined per design by ten questions in the Danish National Well-being Questionaire with answer possibilities 1 - 5 (Likert scale) and with one question ranging from 1 - 4. All data has already been processed by Statistics Denmark, thus questions phrased negatively have been inverted and the question ranging from 1 - 4 has been recalculated fitting a 1 - 5 scale.
The cumulative score ranging from 10 to 50 now depicts the adolescent's mental and physical well-being from low to high corresponding to the numeric value.
A corrected value will be calculated for all adolescents who answered 1 to 9 questions on the questionnaire.
|
During school year 2020/2021 and/or 2021/2022
|
|
Subgroup differences for the effect of nicotine pouch consumption and mental and physical well-being (the combined DNWQ questionnaire) for different strata of socioeconomic status, age, sex and origin
Periodo de tiempo: During school year 2020/2021 and/or 2021/2022
|
Mental and physical well-being score are defined per design by ten questions in the Danish National Well-being Questionaire with answer possibilities 1 - 5 (Likert scale) and with one question ranging from 1 - 4. All data has already been processed by Statistics Denmark, thus questions phrased negatively have been inverted and the question ranging from 1 - 4 has been recalculated fitting a 1 - 5 scale.
The cumulative score ranging from 10 to 50 now depicts the adolescent's mental and physical well-being from low to high corresponding to the numeric value.
A corrected value will be calculated for all adolescents who answered 1 to 9 questions on the questionnaire.
|
During school year 2020/2021 and/or 2021/2022
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- 118560-3
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .