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

1 juillet 2026 mis à jour par: 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

Aperçu de l'étude

Type d'étude

Observationnel

Inscription (Réel)

10800

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

N/A

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Les contrôles
Nicotine pouch users
Undisclosed use of nicotine pouches

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Days of illegal school absence and due to sickness
Délai: During school year 2020/2021 and/or 2021/2022
During school year 2020/2021 and/or 2021/2022
Mental and physical well-being score
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Group differences in response patterns of each of the 10 items for physical and mental well-being score
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 septembre 2020

Achèvement primaire (Réel)

1 septembre 2022

Achèvement de l'étude (Réel)

25 juin 2026

Dates d'inscription aux études

Première soumission

25 juin 2026

Première soumission répondant aux critères de contrôle qualité

25 juin 2026

Première publication (Réel)

1 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 118560-3

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime 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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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