- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05308459
Data Health VET - Data-driven Health Promotion at Vocational Education and Training Schools
Data Driven Health Promotion at Vocational Education and Training Schools (The Data Health VET Study)
Study Overview
Status
Detailed Description
Background:
Recent evidence shows that vocational education and training (VET) school students exhibits significant risk behaviors in terms of poor diet, frequent smoking, low levels of physical activity and poor mental health.
Health behavior constitutes a complex problem that is influenced by underlying, dynamic mechanisms and determinants at multiple levels. A system perspective is an evidence-based approach that has the potential to address and initiate sustainable changes to complex health problems, but studies are needed to translate, test, and adapt such evidence-based methods to the VET school setting.
Objective:
Data driven Health promotion at Vocational Education and Training schools (the Data Health VET study) aims to develop a sustainable model to promote health and wellbeing among vocational school students. The objective of this study is to investigate the effectiveness of the model.
Design:
A non-randomized clustered stepped-wedge design will be applied. Eight intervention schools will be included in two steps:
Step 1: early starters (January 2022) Step 2: late starters (August 2022).
Intervention:
The intervention consists of the following steps:
- A local health profile is conducted among all students
- 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
- 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
- The activities are implemented
- 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).
Participants:
The eight intervention schools are located in the capital region of Denmark and Region Zealand and have been recruited so each region participates with one school from each of four, main vocational educational tracks: 1) technical (e.g. electrician), 2) business (e.g. office assistant), 3) agriculture and food service (e.g. farmer or chef) and 4) social and health service (e.g. health service assistant). Across the eight intervention schools the target population is estimated to be at student level n=1800, staff members and mangers: n≈160, other involved local partners (n≈80). All are eligible for both intervention and evaluation.
Study measures:
The study investigates 1) changes in student's health behaviour and wellbeing and 2) changes in organizational motivation and capacity to work with and implement health promotion initiatives. The primary and secondary student outcome measure for each cluster depends on the chosen health promotion theme. Moreover, the study explores if the intervention influences different student health promotion outcomes (e.g. health literacy, motivation, knowledge).
Data Health VET will provide solid evidence of the effects of the Data Health VET model, which is needed in practice to inform the scale-up of the model to other VET schools or settings. The study is conducted in partnership between the applying institutions and the participating schools and municipalities through all phases.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Herlev, Denmark, 2730
- Steno Diabetes Center Copenhagen
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Holbæk, Denmark, 4300
- Steno Diabetes Center Zealand
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Step 1: Allocated to start the Data Health VET intervention phase January 2022
Participants receive the Data Health VET intervention in all its steps starting in January 2022
|
The intervention consists of the following steps:
|
|
Experimental: Step 2: Allocated to start the Data Health VET intervention phase August, 2022
Participants receive the Data Health VET intervention in all its steps starting in August 2022
|
The intervention consists of the following steps:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wellbeing during schooltime (student outcome)
Time Frame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
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)
Time Frame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
Changes will be measured using the Saltin-Grimby Physical Activity Level Scale (SGPALS) adapted to the school setting
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Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
|
Food intake during schooltime (student outcome)
Time Frame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
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
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Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
|
Tobacco use during schooltime (student outcome)
Time Frame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
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)
Time Frame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
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)
Time Frame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
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)
Time Frame: The questionnaire will be distributed among the school staff at baseline, T1 (6 months), T2 (12 months) and T3 (24 months).
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wellbeing (student outcome)
Time Frame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
Changes will be measured using WHO-5 questionnaire
|
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
|
Physical activity (student outcome)
Time Frame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
Changes will be measured using the SGPALS
|
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
|
Food intake (student outcome)
Time Frame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
Changes will be measured using an adapted version of dietary behavior used in the HBSC survey.
Participants will be asked about their frequency in which they consumed various food on a normal week
|
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
|
Tobacco use (student outcome)
Time Frame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
Changes will be measured by asking the participants if they smoke cigarettes, e-cigarettes or uses snuff or other tobacco products
|
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
|
Alcohol consumption (student outcome)
Time Frame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
Changes in Binge drinking will be measured by asking participants how often they have been drinking 5 or more drinks on the same occasion in the past 30 days
|
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
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Marihuana and drug use(student outcome)
Time Frame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
Changes will be measured by asking the participants how often they have used the products the past 30 days
|
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health Literacy (student outcome)
Time Frame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
Changes in students health Literacy (HL) is measures using the Health Literacy for School-Aged Children (HLSAC) questionnaire (10 items).
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Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
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Knowledge relevant to the problem of interest (student outcome)
Time Frame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
Changes in knowledge relevant to the problem of interest (wellbeing, physical activity, healthy food intake, smoking, alcohol) will be measured by 5 self-developed items, specified from the knowledge question from HLSAC.
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Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
|
Behavioral intentions (student outcome)
Time Frame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
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Changes in behavioral intentions will be measured using 5 items from The Danish National Health Survey.
|
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
|
Motivation (student outcome)
Time Frame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
Changes in motivation relevant to the problem of interest (physical activity, healthy food intake, smoking, alcohol) will be measured by 4 items from The Danish National Health Survey.
|
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
|
Social connectedness (student outcome)
Time Frame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
Changes in social connectedness will be measured by tree items used in the HBSC survey.
|
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
|
Self-empowerment (student outcome)
Time Frame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
Changes in self-empowerment will be measured using the Actively managing my health domain from Health Literacy Questionnaire (HLQ) (5 items)
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Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
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Self-confidence (student outcome)
Time Frame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
Changes in self-confidence (self-efficacy and self-esteem) will be measured with two items used in the HBSC survey.
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Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
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Student autonomy (student outcome)
Time Frame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
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Changes in student autonomy will be measured by two items adapted from the HBSC survey.
|
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
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Social relationships (student outcome)
Time Frame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
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Changes in social relationships will be measured by two items from The Danish National Health Survey.
|
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Charlotte D Klinker, PhD, Steno Diabetes Center Copenhagen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- Data Health VET
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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