Clinical trial NCT05308459: Data Health VET - Data-driven Health Promotion at Vocational Education and Training Schools
Official title: Data Driven Health Promotion at Vocational Education and Training Schools (The Data Health VET Study)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Food Habits
Physical Inactivity
Smoking Behaviors
Drug Use
Alcohol Consumption
Wellbeing
Keywords: Vocational school
Health behavior
Organizational Readiness
Health promotion
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
Collaborators: name: Steno Diabetes Center Sjaelland
name: University of Southern Denmark
First posted: 2022-04-04
Enrollment: 1370
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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:

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Wellbeing during schooltime (student outcome)
timeFrame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
measure: Physical activity level during schooltime (student outcome)
timeFrame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
measure: Food intake during schooltime (student outcome)
timeFrame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
measure: Tobacco use during schooltime (student outcome)
timeFrame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
measure: Alcohol consumption during schooltime (student outcome)
timeFrame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
measure: Marihuana and drug use during schooltime (student outcome)
timeFrame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
measure: Organizational Readiness (organizational outcome)
timeFrame: The questionnaire will be distributed among the school staff at baseline, T1 (6 months), T2 (12 months) and T3 (24 months).
Secondary outcomes:
measure: Wellbeing (student outcome)
timeFrame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
measure: Physical activity (student outcome)
timeFrame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
measure: Food intake (student outcome)
timeFrame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
measure: Tobacco use (student outcome)
timeFrame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
measure: Alcohol consumption (student outcome)
timeFrame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
measure: Marihuana and drug use(student outcome)
timeFrame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Other outcomes:
measure: Health Literacy (student outcome)
timeFrame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
measure: Knowledge relevant to the problem of interest (student outcome)
timeFrame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
measure: Behavioral intentions (student outcome)
timeFrame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
measure: Motivation (student outcome)
timeFrame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
measure: Social connectedness (student outcome)
timeFrame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
measure: Self-empowerment (student outcome)
timeFrame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
measure: Self-confidence (student outcome)
timeFrame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
measure: Student autonomy (student outcome)
timeFrame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
measure: Social relationships (student outcome)
timeFrame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Locations:
city: Herlev
country: Denmark
facility: Steno Diabetes Center Copenhagen
city: Holbæk
country: Denmark
facility: Steno Diabetes Center Zealand
Study officials:
affiliation: Steno Diabetes Center Copenhagen
name: Charlotte D Klinker, PhD
role: PRINCIPAL_INVESTIGATOR
References: