NCT05308459

Brief Summary

The purpose of this study is to investigate the effectiveness of a data driven and dynamic systems approach at Danish Vocational schools to promote student health behavior and wellbeing and school organizational readiness.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,370

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 4, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

3 years

First QC Date

March 8, 2022

Last Update Submit

April 15, 2024

Conditions

Keywords

Vocational schoolHealth behaviorOrganizational ReadinessHealth promotion

Outcome Measures

Primary Outcomes (7)

  • Wellbeing during schooltime (student outcome)

    Changes will be measured by asking participants how they feel about school at present

    Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)

  • Physical activity level during schooltime (student outcome)

    Changes will be measured using the Saltin-Grimby Physical Activity Level Scale (SGPALS) adapted to the school setting

    Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)

  • Food intake during schooltime (student outcome)

    Changes will be measured using an adapted version of dietary behavior used in the large national and international Health Behavior in School-aged Children (HBSC) survey. Participants will be asked about their frequency in which they consumed various food during school time on a normal school week

    Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)

  • Tobacco use during schooltime (student outcome)

    Changes will be measured by asking the participants if they smoke cigarettes, e-cigarettes or uses snuff or other tobacco products during schooltime

    Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)

  • Alcohol consumption during schooltime (student outcome)

    Changes will be measured by asking the participants if they consume alcohol during schooltime

    Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)

  • Marihuana and drug use during schooltime (student outcome)

    Changes will be measured by asking the participants if they use the products during schooltime

    Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)

  • Organizational Readiness (organizational outcome)

    Changes in the schools Organizational Readiness (OR) is measured using a questionnaire instrument measuring 1) Organizational motivation, 2) General capacity and 3) Health Promotion Capacity as proposed in Scaccia et al. 2015's organizational readiness theory. The three domains are predominantly measured using validated scales with some adjustments and additions to comply with the study and setting.

    The questionnaire will be distributed among the school staff at baseline, T1 (6 months), T2 (12 months) and T3 (24 months).

Secondary Outcomes (6)

  • Wellbeing (student outcome)

    Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)

  • Physical activity (student outcome)

    Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)

  • Food intake (student outcome)

    Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)

  • Tobacco use (student outcome)

    Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)

  • Alcohol consumption (student outcome)

    Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)

  • +1 more secondary outcomes

Other Outcomes (9)

  • Health Literacy (student outcome)

    Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)

  • Knowledge relevant to the problem of interest (student outcome)

    Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)

  • Behavioral intentions (student outcome)

    Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)

  • +6 more other outcomes

Study Arms (2)

Step 1: Allocated to start the Data Health VET intervention phase January 2022

EXPERIMENTAL

Participants receive the Data Health VET intervention in all its steps starting in January 2022

Behavioral: Data-driven health promotion at Vocational Education and Training schools (Data Health VET)

Step 2: Allocated to start the Data Health VET intervention phase August, 2022

EXPERIMENTAL

Participants receive the Data Health VET intervention in all its steps starting in August 2022

Behavioral: Data-driven health promotion at Vocational Education and Training schools (Data Health VET)

Interventions

The intervention consists of the following steps: 1. A local health profile is conducted among all students 2. Results are shortly hereafter presented and discussed with all student and staff, and the school decide what health problem they will work with during the next year 3. A participatory group model process based on a dynamic systems approach is conducted to develop sustainable and system changing activities to address the chosen health problem 4. The activities are implemented 5. A new health profile is conducted to a) evaluate the effects of the implemented activities and to b) determine if a new health problem warrant focus and new activities are needed (the process repeats itself).

Step 1: Allocated to start the Data Health VET intervention phase January 2022Step 2: Allocated to start the Data Health VET intervention phase August, 2022

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All employees at the participating schools
  • All students who are at the school at the time for data collection
  • Participants who have provided written informed consent.

You may not qualify if:

  • Schools which do not develop and implement any activities that aim to promote health among the students will be excluded from the analysis on student level but will be included in the analysis on organizational level.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Steno Diabetes Center Copenhagen

Herlev, 2730, Denmark

Location

Steno Diabetes Center Zealand

Holbæk, 4300, Denmark

Location

Related Publications (1)

  • Heinze C, Hartmeyer RD, Sidenius A, Ringgaard LW, Bjerregaard AL, Krolner RF, Allender S, Bauman A, Klinker CD. Developing and Evaluating a Data-Driven and Systems Approach to Health Promotion Among Vocational Students: Protocol for the Data Health Study. JMIR Res Protoc. 2024 Feb 6;13:e52571. doi: 10.2196/52571.

MeSH Terms

Conditions

Feeding BehaviorSedentary BehaviorSmokingAlcohol DrinkingHealth Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorDrinking Behavior

Study Officials

  • Charlotte D Klinker, PhD

    Steno Diabetes Center Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: A non-randomized clustered stepped-wedge design with two steps will be applied. Four VET schools (one from each of the four main educations tracks) are selected to early start (January 2022) and four to late start - also one from each of the four main educational tracks (6 months later). This design allows the intervention to be rolled out sequential, allowing us to control for differences between study sites (vertical control) and secular trends (horizontal control) during the study period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior researcher

Study Record Dates

First Submitted

March 8, 2022

First Posted

April 4, 2022

Study Start

January 19, 2022

Primary Completion

December 31, 2024

Study Completion

June 30, 2025

Last Updated

April 16, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations