Mental Well-beingNCT07678853
Mental and Physical Well-being and School Absence Among School Children Using Nicotine Pouches Compared to Their Peers
An observational study of Mental Well-being and Physical Well-Being, run by University of Southern Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mental Well-being, Physical Well-Being, Adolescent
- How many people
- 10,800 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2020to 25 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Danish adolescents, age 13-18 years, from Aarhus municipality between September 2020 to June 2022
Who may be able to join
- 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
Who cannot join
- Student in a special needs class or reception class for newcomers
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Nicotine pouch users | Not described | |
| Undisclosed use of nicotine pouches | Not described | |
| Controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During school hours in school year 2020/2021 and/or 2021/2022
Days of illegal school absence and due to sickness
Measured: 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
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.
Measured: 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
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.
Measured: During school year 2020/2021 and/or 2021/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Sep 2020
- Primary completion1 Sep 2022
- Study completion25 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Well-beingStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Aarhus County, Denmark
- Responsible party
- Principal investigator, Mathies Appel Aggerbeck, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678853
- Sponsor's protocol ID
- 118560-3
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental and Physical Well-being and School Absence Among School Children Using Nicotine Pouches Compared to Their Peers
- ClinicalTrials.gov ID
- NCT07678853
- Acronym / sponsor ID
- 118560-3
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,800 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Aarhus County, Denmark
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 25 Jun 2026 (actual)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nicotine pouch users | – | – |
| Undisclosed use of nicotine pouches | – | – |
| Controls | – | – |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Danish adolescents, age 13-18 years, from Aarhus municipality between September 2020 to June 2022
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Student in a special needs class or reception class for newcomers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mental and physical well-being score
Time frame: 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.
Days of illegal school absence and due to sickness
Time frame: During school year 2020/2021 and/or 2021/2022
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Well-being and Physical Well-Being, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental and physical well-being score (time frame: During school hours in school year 2020/2021 and/or 2021/2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.