- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kolding, Denmark, 6000
- Department of Pediactrics, Sygehus Lillebælt
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Controls
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Nicotine pouch users
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Undisclosed use of nicotine pouches
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Mental and physical well-being score
Time Frame: During school hours in school year 2020/2021 and/or 2021/2022
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During school hours in school year 2020/2021 and/or 2021/2022
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Days of illegal school absence and due to sickness
Time Frame: During school year 2020/2021 and/or 2021/2022
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During school year 2020/2021 and/or 2021/2022
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Group differences in response patterns of each of the 10 items for physical and mental well-being score
Time Frame: During school year 2020/2021 and/or 2021/2022
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During school year 2020/2021 and/or 2021/2022
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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
Time Frame: During school year 2020/2021 and/or 2021/2022
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During school year 2020/2021 and/or 2021/2022
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 118560-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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