NCT06022120

Brief Summary

The linkage between lower educational levels and poorer health has been highlighted as a mechanism contributing to social inequality in health. However, more research on this mechanism among youth is needed, e.g. to ensure timing of primary prevention of diseases. Additionally, health literacy (HL) has been increasingly recognized as a means of reducing health inequalities. However, knowledge on best practice for HL interventions among youth is scarce. The aim of this project is to develop, test, and evaluate an integrated, participatory intervention to improve HL among young adults in Danish school settings.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 9, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

1.1 years

First QC Date

August 9, 2023

Last Update Submit

September 10, 2025

Conditions

Keywords

Health LiteracyHealth behaviorInterventionSchool contextYouth

Outcome Measures

Primary Outcomes (1)

  • Health Literacy

    Change of health literacy level measured by HLS19-Q12 (Danish version), ranging from 1-4, with higher scores indicating a higher level of health literacy, from baseline to 3 and 6 months after randomization.

    Data on health literacy are collected at baseline and follow up data are collected 3 and 6 months after randomization.

Secondary Outcomes (8)

  • Self-perceived health

    Data on self-perceived health are collected at baseline and follow up data are collected 3 and 6 months after randomization.

  • Life satisfaction

    Data on life satisfaction are collected at baseline and follow up data are collected 3 and 6 months after randomization.

  • Mental health

    Data on mental health are collected at baseline and follow up data are collected 3 and 6 months after randomization.

  • Self efficacy

    Data on self efficacy are collected at baseline and follow up data are collected 3 and 6 months after randomization.

  • Ressources for health promotion

    Data on ressources for health promotion are collected at baseline and follow up data are collected 3 and 6 months after randomization.

  • +3 more secondary outcomes

Study Arms (2)

An integrated health literacy intervention

OTHER

Intervention: A group of students at each school will develop and implement their own project activities at meetings two times during the intervention. Activities are implemented in schools for all students.

Behavioral: An integrated health literacy intervention

Reference

NO INTERVENTION

No intervention activities

Interventions

The intervention investigates the effect of the Australian WorkHealth Improvement Network (WIN) program and the Total Worker Health (TWH) concepts in a Danish contexts among students at risk of poorer health outcomes compared to their peers with stronger literacy skills.

An integrated health literacy intervention

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Providing an informed signed consent prior to participation.
  • Student at one of the enrolled schools
  • years of age or turns 15 during the project period.

You may not qualify if:

  • Under the age of 15 and does not turn 15 during the project period.
  • above the age of 25 before the project period starts.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Occupational and Social Medicine, Holbaek Hospital

Holbæk, Region Sjælland, 4300, Denmark

Location

MeSH Terms

Conditions

BehaviorHealth Behavior

Study Officials

  • Vivian Rueskov Poulsen

    Holbæk Sygehus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Using a stepped-wedge design, participants at the enrolled schools function as their own control. Thus, the effect of the intervention is evaluated as in an RCT design. All participants are asked to indicate whether they want to participate in the scientific evaluation of the intervention. Those who wish to participate are invited to the data collection containing: Signing of consent and answering questionnaires. No preparation is required of the participants before data collection begins. Smaller groups of students and teachers participate in focus groups as part of the process evaluation. All intervention activities take place at the participants' school. Calculation, analysis and interpretation of data will take place at the Department of Occupational and Social Medicine, Holbæk Hospital. The intervention activities are developed by a student commitee, accoording to a participatory approach and following the Work Health Improvements Network concept.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2023

First Posted

September 1, 2023

Study Start

July 1, 2023

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

September 16, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

We do not plan to share any individual participant data with other researchers.

Locations