Data Health VET - Data-driven Health Promotion at Vocational Education and Training Schools

Physical Inactivity Clinical Trial

Official title:

Data Driven Health Promotion at Vocational Education and Training Schools (The Data Health VET Study)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05308459
• Other study ID #: Data Health VET
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 19, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: Steno Diabetes Center Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1370
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Consumption
• Alcohol Drinking
• Drug Use
• Food Habits
• Physical Inactivity
• Smoking Behaviors
• Wellbeing

Intervention

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

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center Copenhagen	Herlev
Denmark	Steno Diabetes Center Zealand	Holbæk

Sponsors (3)

Lead Sponsor	Collaborator
Steno Diabetes Center Copenhagen	Steno Diabetes Center Sjaelland, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health Literacy (student outcome)	Changes in students health Literacy (HL) is measures using the Health Literacy for School-Aged Children (HLSAC) questionnaire (10 items).	Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Other	Knowledge relevant to the problem of interest (student outcome)	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.	Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Other	Behavioral intentions (student outcome)	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)
Other	Motivation (student outcome)	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)
Other	Social connectedness (student outcome)	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)
Other	Self-empowerment (student outcome)	Changes in self-empowerment will be measured using the Actively managing my health domain from Health Literacy Questionnaire (HLQ) (5 items)	Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Other	Self-confidence (student outcome)	Changes in self-confidence (self-efficacy and self-esteem) will be measured with two items used in the HBSC survey.	Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Other	Student autonomy (student outcome)	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)
Other	Social relationships (student outcome)	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Wellbeing (student outcome)	Changes will be measured using WHO-5 questionnaire	Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Secondary	Physical activity (student outcome)	Changes will be measured using the SGPALS	Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Secondary	Food intake (student outcome)	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)
Secondary	Tobacco use (student outcome)	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)
Secondary	Alcohol consumption (student outcome)	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)
Secondary	Marihuana and drug use(student outcome)	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)