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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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20 June 2023 |
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Main ID: |
ISRCTN43284296 |
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Date of registration:
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28/04/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Healthy High School: a high school intervention to improve well-being among students
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Scientific title:
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Healthy High School: a cluster randomised, multi-component, high school-based trial to improve well-being among students |
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Date of first enrolment:
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06/04/2016 |
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Target sample size:
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6097 |
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Recruitment status: |
Completed |
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URL:
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https://www.isrctn.com/ISRCTN43284296 |
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Study type:
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Interventional |
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Study design:
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Cluster-randomised controlled trial (Quality of life)
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Phase:
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Not Applicable
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Rikke Fredenslund
Krølner |
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Address:
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Øster Farimagsgade 5A, 2nd floor
1353
Copenhagen K
Denmark |
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Telephone:
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+45 (0)6550 7841 |
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Email:
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rkr@niph.dk |
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Affiliation:
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Attending high schools with a minimum of two school year 1 classes that participated in the Danish National Youth Study 2014, in which 66% of all Danish High Schools attended
2. First year students attending the general upper secondary education provision of the Gymnasium (the stx programme) in the school year 20016/2017
Exclusion criteria:
1. Students attending International upper secondary school classes
2. Students in classes participating in the Team Danmark programme
3. High schools with a majority of boarding school students
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Well-being, movement, meal and eating habits, stress, sleep and sense of community
Not Applicable
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Intervention(s)
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A strategic sample of 40 high schools, which had all participated in the Danish National Youth Study (DNYS) 2014, was invited to participate in the study. DNYS 2014 is a national questionnaire survey focusing on health behaviour, health and well-being among Danish high school students. All high schools in Denmark (n=137) were invited to participate in DNYS of which 119 high schools accepted the invitation. Data from DNYS was used to rank the high schools based on the students’ answers to the Cantril Ladder of Life Scale. The 40 high schools with the lowest proportion of students with a high level of well-being (rating 7-10 on the Cantril Ladder) comprised the strategic sample and were invited to participate in the study. Schools were randomized into intervention and control groups by computer-based random number generation. Selection of target group, development of the intervention programme and evaluation design is guided by the Intervention Mapping protocol.
Students in high school year 1 (˜age 16) at the intervention schools receive the intervention programme (described below) during school year 2016/17 (nine months), whereas students at the control schools do not receive any intervention (no treatment). Intervention components will be offered to the control schools after the finalisation of the project.
Timeline:
Baseline survey: August 2016
Implementation of intervention in intervention high schools: August 2016-April 2017
First follow-up survey: May 2017
Second follow-up survey: April/May 2018
Intervention programme:
Program activities were organized within two settings (at high school and in the leisure time setting)
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Primary Outcome(s)
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Well-being, measured using the WHO-Five Well-Being Index and the Cantril Ladder of Life Scale (online survey) at 1st and 2nd follow-up
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Secondary Outcome(s)
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1. Stress, measured by:
1.1. The 10-item Perceived Stress Scale (online survey)
1.2. Stress intensity and stress frequency (online survey and SMS survey)
2. Sleep, measured by:
2.1. Sleep quantity (online survey)
2.2. Sleep quality (online survey)
3. Movement, measured by:
3.1. Hours of moderate-to-vigorous physical activity per week (online survey)
3.2. Average daily physical activity measured in a subsample (accelerometer)
3.3. Hours of daily sedentary time (online survey, accelerometer)
4. Meal and eating habits, measured by:
4.1. Daily intake of breakfast (online survey)
4.2. Daily intake of lunch (online survey)
4.3. Daily intake of water (online survey)
5. Sense of community, measured by:
5.1. Sense of community at high school (online survey)
5.2. School class sense of community (online survey)
All secondary outcome measures will be measured at both 1st and 2nd follow-up.
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Secondary ID(s)
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02-2015-1364
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Source(s) of Monetary Support
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TrygFonden, Nordea-fonden
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Ethics review
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Status:
Approval date:
Contact:
There is no formal institution for ethical assessment and approval of questionnaire-based population studies in Denmark. Conforming to current national legislation, the project was submitted to The Regional Scientific Ethical Committees, The Capital Region of Denmark. The committee decided that the project was exempt from the obligation to notify. Notification of this decision was forwarded via email 04/03/2016, ref: J.nr 16018722. This project is registered at the Danish Data Protection Agency,
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/06/2019 |
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URL:
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