Data Health VET - Data-driven Health Promotion at Vocational Education and Training Schools
Primary Purpose
Food Habits, Physical Inactivity, Smoking Behaviors
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Data-driven health promotion at Vocational Education and Training schools (Data Health VET)
Sponsored by
About this trial
This is an interventional prevention trial for Food Habits focused on measuring Vocational school, Health behavior, Organizational Readiness, Health promotion
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.
Sites / Locations
- Steno Diabetes Center CopenhagenRecruiting
- Steno Diabetes Center ZealandRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
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
Arm Description
Participants receive the Data Health VET intervention in all its steps starting in January 2022
Participants receive the Data Health VET intervention in all its steps starting in August 2022
Outcomes
Primary Outcome Measures
Wellbeing during schooltime (student outcome)
Changes will be measured by asking participants how they feel about school at present
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
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
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
Alcohol consumption during schooltime (student outcome)
Changes will be measured by asking the participants if they consume alcohol during schooltime
Marihuana and drug use during schooltime (student outcome)
Changes will be measured by asking the participants if they use the products during schooltime
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.
Secondary Outcome Measures
Wellbeing (student outcome)
Changes will be measured using WHO-5 questionnaire
Physical activity (student outcome)
Changes will be measured using the SGPALS
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
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
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
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
Full Information
NCT ID
NCT05308459
First Posted
March 8, 2022
Last Updated
May 30, 2023
Sponsor
Steno Diabetes Center Copenhagen
Collaborators
Steno Diabetes Center Sjaelland, University of Southern Denmark
1. Study Identification
Unique Protocol Identification Number
NCT05308459
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 19, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Steno Diabetes Center Copenhagen
Collaborators
Steno Diabetes Center Sjaelland, University of Southern Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Habits, Physical Inactivity, Smoking Behaviors, Drug Use, Alcohol Consumption, Wellbeing
Keywords
Vocational school, Health behavior, Organizational Readiness, Health promotion
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Non-Randomized
Enrollment
1370 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Step 1: Allocated to start the Data Health VET intervention phase January 2022
Arm Type
Experimental
Arm Description
Participants receive the Data Health VET intervention in all its steps starting in January 2022
Arm Title
Step 2: Allocated to start the Data Health VET intervention phase August, 2022
Arm Type
Experimental
Arm Description
Participants receive the Data Health VET intervention in all its steps starting in August 2022
Intervention Type
Behavioral
Intervention Name(s)
Data-driven health promotion at Vocational Education and Training schools (Data Health VET)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Wellbeing during schooltime (student outcome)
Description
Changes will be measured by asking participants how they feel about school at present
Time Frame
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Title
Physical activity level during schooltime (student outcome)
Description
Changes will be measured using the Saltin-Grimby Physical Activity Level Scale (SGPALS) adapted to the school setting
Time Frame
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Title
Food intake during schooltime (student outcome)
Description
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
Time Frame
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Title
Tobacco use during schooltime (student outcome)
Description
Changes will be measured by asking the participants if they smoke cigarettes, e-cigarettes or uses snuff or other tobacco products during schooltime
Time Frame
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Title
Alcohol consumption during schooltime (student outcome)
Description
Changes will be measured by asking the participants if they consume alcohol during schooltime
Time Frame
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Title
Marihuana and drug use during schooltime (student outcome)
Description
Changes will be measured by asking the participants if they use the products during schooltime
Time Frame
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Title
Organizational Readiness (organizational outcome)
Description
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.
Time Frame
The questionnaire will be distributed among the school staff at baseline, T1 (6 months), T2 (12 months) and T3 (24 months).
Secondary Outcome Measure Information:
Title
Wellbeing (student outcome)
Description
Changes will be measured using WHO-5 questionnaire
Time Frame
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Title
Physical activity (student outcome)
Description
Changes will be measured using the SGPALS
Time Frame
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Title
Food intake (student outcome)
Description
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
Time Frame
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Title
Tobacco use (student outcome)
Description
Changes will be measured by asking the participants if they smoke cigarettes, e-cigarettes or uses snuff or other tobacco products
Time Frame
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Title
Alcohol consumption (student outcome)
Description
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
Time Frame
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Title
Marihuana and drug use(student outcome)
Description
Changes will be measured by asking the participants how often they have used the products the past 30 days
Time Frame
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Other Pre-specified Outcome Measures:
Title
Health Literacy (student outcome)
Description
Changes in students health Literacy (HL) is measures using the Health Literacy for School-Aged Children (HLSAC) questionnaire (10 items).
Time Frame
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Title
Knowledge relevant to the problem of interest (student outcome)
Description
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.
Time Frame
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Title
Behavioral intentions (student outcome)
Description
Changes in behavioral intentions will be measured using 5 items from The Danish National Health Survey.
Time Frame
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Title
Motivation (student outcome)
Description
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.
Time Frame
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Title
Social connectedness (student outcome)
Description
Changes in social connectedness will be measured by tree items used in the HBSC survey.
Time Frame
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Title
Self-empowerment (student outcome)
Description
Changes in self-empowerment will be measured using the Actively managing my health domain from Health Literacy Questionnaire (HLQ) (5 items)
Time Frame
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Title
Self-confidence (student outcome)
Description
Changes in self-confidence (self-efficacy and self-esteem) will be measured with two items used in the HBSC survey.
Time Frame
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Title
Student autonomy (student outcome)
Description
Changes in student autonomy will be measured by two items adapted from the HBSC survey.
Time Frame
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
Title
Social relationships (student outcome)
Description
Changes in social relationships will be measured by two items from The Danish National Health Survey.
Time Frame
Baseline, T1 (12 months), T2 (18 months) and T3 (24 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte D. Klinker, PhD
Phone
+4527290680
Email
charlotte.demant.klinker@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Clara Heinze, Master
Phone
+4528838889
Email
clara.heinze@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlotte D Klinker, PhD
Organizational Affiliation
Steno Diabetes Center Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Steno Diabetes Center Copenhagen
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte D Klinker, PhD
Phone
+4527290680
Email
charlotte.demant.klinker@regionh.dk
First Name & Middle Initial & Last Name & Degree
Clara Heinze, Master
Phone
+4528838889
Email
clara.heinze@regionh.dk
Facility Name
Steno Diabetes Center Zealand
City
Holbæk
ZIP/Postal Code
4300
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Louise Bjerregaard, PhD
Phone
+ 4561922320
Email
abjerr@regionsjaelland.dk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Data Health VET - Data-driven Health Promotion at Vocational Education and Training Schools
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