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

NCT07678853 | Completed DMC

• 1 other identifier: 118560-3
• Study Type: observational
• Target: 10,800
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mental Well-being; Physical Well-Being; Adolescent; Nicotine Pouch Self-Administration; Absence

Keywords

Nicotine; Nicotine pouches; Mental well-being; Physical well-being; Absence; Adolescents

Outcome Measures

Primary Outcomes (2)

• Mental and physical well-being score

  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

• Days of illegal school absence and due to sickness

  During school year 2020/2021 and/or 2021/2022

Secondary Outcomes (2)

• Group differences in response patterns of each of the 10 items for physical and mental well-being score

  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

  During school year 2020/2021 and/or 2021/2022

Study Arms (3)

Nicotine pouch users

Undisclosed use of nicotine pouches

Controls

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Student in a special needs class or reception class for newcomers

Sponsors & Collaborators

• University of Southern Denmark: lead
• Aarhus University Hospital: collaborator
• Aarhus County, Denmark: collaborator

Study Sites (1)

Department of Pediactrics, Sygehus Lillebælt

Kolding, 6000, Denmark

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start: September 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: June 25, 2026
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)