Food HabitsNCT05308459
Data Health VET - Data-driven Health Promotion at Vocational Education and Training Schools
A study testing Data-driven health promotion at Vocational Education and Training schools (Data Health VET) in people with Food Habits and Physical Inactivity, run by Steno Diabetes Center Copenhagen at 2 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Habits, Physical Inactivity, Smoking Behaviors
- What is being tested?
- Data-driven health promotion at Vocational Education and Training schools (Data Health VET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,370 participants
- Where
- 2 sitesDenmark
- Study dates
- 19 Jan 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Steno Diabetes Center Copenhagen
Herlev, 2730
Steno Diabetes Center Zealand
Holbæk, 4300
About this study
Official title: Data Driven Health Promotion at Vocational Education and Training Schools (The Data Health VET Study)
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.
Read the 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.
- Conditions
- Food Habits, Physical Inactivity, Smoking Behaviors, Drug Use, Alcohol Consumption, Wellbeing
- Being tested
- Data-driven health promotion at Vocational Education and Training schools (Data Health VET)
- Keywords
- Vocational school, Health behavior, Organizational Readiness, Health promotion
- Medical subject headings
- Feeding Behavior, Sedentary Behavior, Smoking, Alcohol Drinking, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data-driven health promotion at Vocational Education and Training schools (Data Health VET)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Data-driven health promotion at Vocational Education and Training schools (Data Health VET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wellbeing during schooltime (student outcome)
Changes will be measured by asking participants how they feel about school at present
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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)
Changes will be measured using WHO-5 questionnaire
Measured: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Physical activity (student outcome)
Changes will be measured using the SGPALS
Measured: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
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
Measured: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
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
Measured: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
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
Measured: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
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
Measured: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start19 Jan 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Food HabitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 1,370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Steno Diabetes Center Sjaelland, University of Southern Denmark
- Responsible party
- Principal investigator, Charlotte Demant Klinker, Steno Diabetes Center Copenhagen
- Investigators
- Charlotte D Klinker, PhD, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308459
- Sponsor's protocol ID
- Data Health VET
- Status last verified
- Apr 2024
- First submitted
- 8 Mar 2022
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heinze C, Johnsen HR, Krolner RF, Klinker CD. Implementation and systems impact of a systems-based health promotion programme at Danish vocational schools: results after 2-years follow-up. BMC Public Health. 2026 Jun 23. doi: 10.1186/s12889-026-28208-0. Online ahead of print.
PubMed 42332640Heinze 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.
PubMed 38319698
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Driven Health Promotion at Vocational Education and Training Schools (The Data Health VET Study)
- ClinicalTrials.gov ID
- NCT05308459
- Acronym / sponsor ID
- Data Health VET
- Conditions
- Food Habits, Physical Inactivity, Smoking Behaviors, Drug Use, Alcohol Consumption, Wellbeing
- Keywords
- Vocational school, Health behavior, Organizational Readiness, Health promotion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,370 participants (estimated)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Collaborators
- Steno Diabetes Center Sjaelland, University of Southern Denmark
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Step 1: Allocated to start the Data Health VET intervention phase January 2022 | Experimental | Behavioral: Data-driven health promotion at Vocational Education and Training schools (Data Health VET)Participants receive the Data Health VET intervention in all its steps starting in January 2022 |
| Step 2: Allocated to start the Data Health VET intervention phase August, 2022 | Experimental | Behavioral: Data-driven health promotion at Vocational Education and Training schools (Data Health VET)Participants receive the Data Health VET intervention in all its steps starting in August 2022 |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data-driven health promotion at Vocational Education and Training schools (Data Health VET)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). | Behavioural | Step 1: Allocated to start the Data Health VET intervention phase January 2022, Step 2: Allocated to start the Data Health VET intervention phase August, 2022 |
Primary outcome
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
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
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
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
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
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
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.
6 secondary outcomes
Wellbeing (student outcome)
Time frame: 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)
Food intake (student outcome)
Time frame: 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)
Alcohol consumption (student outcome)
Time frame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Marihuana and drug use(student outcome)
Time frame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Derived from this study: PubMed 42332640Heinze C, Johnsen HR, Krolner RF, Klinker CD. Implementation and systems impact of a systems-based health promotion programme at Danish vocational schools: results after 2-years follow-up. BMC Public Health. 2026 Jun 23. doi: 10.1186/s12889-026-28208-0. Online ahead of print.
- Derived from this study: PubMed 38319698Heinze 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte D Klinker, PhD principal investigator
Steno Diabetes Center Copenhagen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Data-driven health promotion at Vocational Education and Training schools (Data Health VET) in people with Food Habits and Physical Inactivity, run by Steno Diabetes Center Copenhagen at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wellbeing during schooltime (student outcome) (time frame: Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05308459, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.