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Mental and Physical Well-being and School Absence Among School Children Using Nicotine Pouches Compared to Their Peers

1 de julho de 2026 atualizado por: Mathies Appel Aggerbeck, University of Southern Denmark

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

Visão geral do estudo

Tipo de estudo

Observacional

Inscrição (Real)

10800

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Kolding, Dinamarca, 6000
        • Department of Pediactrics, Sygehus Lillebælt

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

N/D

Método de amostragem

Amostra Não Probabilística

População do estudo

Danish adolescents, age 13-18 years, from Aarhus municipality between September 2020 to June 2022

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Controles
Nicotine pouch users
Undisclosed use of nicotine pouches

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Days of illegal school absence and due to sickness
Prazo: During school year 2020/2021 and/or 2021/2022
During school year 2020/2021 and/or 2021/2022
Mental and physical well-being score
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Group differences in response patterns of each of the 10 items for physical and mental well-being score
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de setembro de 2020

Conclusão Primária (Real)

1 de setembro de 2022

Conclusão do estudo (Real)

25 de junho de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

25 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

25 de junho de 2026

Primeira postagem (Real)

1 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 118560-3

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Data has been collected from Aarhus Municipality and Statistics Denmark. Both organizations have strict data policy requirements regarding person-identifiable information, which means that individual participant data cannot be made publicly available, even in anonymized form. Access to the data is restricted to approved researchers working on secure servers under the terms set by these institutions.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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