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

1 luglio 2026 aggiornato da: 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

Panoramica dello studio

Tipo di studio

Osservativo

Iscrizione (Effettivo)

10800

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

N/A

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Controlli
Nicotine pouch users
Undisclosed use of nicotine pouches

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Days of illegal school absence and due to sickness
Lasso di tempo: During school year 2020/2021 and/or 2021/2022
During school year 2020/2021 and/or 2021/2022
Mental and physical well-being score
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Group differences in response patterns of each of the 10 items for physical and mental well-being score
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 settembre 2020

Completamento primario (Effettivo)

1 settembre 2022

Completamento dello studio (Effettivo)

25 giugno 2026

Date di iscrizione allo studio

Primo inviato

25 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

25 giugno 2026

Primo Inserito (Effettivo)

1 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 118560-3

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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