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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. |
Register:
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ISRCTN |
Last refreshed on:
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8 March 2021 |
Main ID: |
ISRCTN12496336 |
Date of registration:
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11/05/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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The role of physical activity in improving the well-being of children and youth
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Scientific title:
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Improving the well-being of children and youth: a multicomponent school-based physical activity intervention |
Date of first enrolment:
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15/12/2014 |
Target sample size:
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1800 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN12496336 |
Study type:
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Interventional |
Study design:
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A four phased intervention:
1. Design phase consolidating the rationale for the intervention, the likely processes of change and further provision of evidence for proposed interventions (February 2014-July 2014).
2. Pilot phase including assessments of how the proposed intervention can be adapted to the school-setting. This entails systematic appraisals of sustainable ways to deliver the in-tervention as prescribed, and examining the key uncertainties that have been identified during the design phase. In the pilot intervention components will be tested to ensure that they are feasible to implement and deemed effective in relation to short-term and/or final outcomes. 4 schools take part in the pilot test (August 2014-April 2015).
3. Cluster randomized controlled trial in order to rigorously test the effectiveness of the full-scale, piloted intervention. 24 schools located in seven of the 98 Danish municipalities have
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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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Thomas
Skovgaard |
Address:
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Campusvej 55
DK-5230
Odense M
Denmark |
Telephone:
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+45 24984064 |
Email:
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tskovgaard@health.sdu.dk |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Children aged 9-12 (4-6th grade) attending public school
Exclusion criteria: Does not meet inclusion criteria
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Well-being and self-concept Not Applicable
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Intervention(s)
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Participating schools will be randomly allocated to either the intervention group or the control group. The control group will be given the opportunity to implement the intervention one year later. Baseline measurements are conducted in the beginning of a school year, followed by final assessment in the end of the school year for all participating schools The intervention involves: 1. Establishment of a coordination group: at each participating school a group consisting of key stakeholders (teachers, principals and student representatives) is assembled in order to establish a foundation for the intervention. 2. Competence development program (CDP) for educators: CDP will train enrolled educators to support student motivation and participation in school-based PA. The CDP will also provide attendees with up-to-date knowledge on topics closely related to PA and psychosocial well-being (support proficiencies and motivate colleagues to take part). 3. Activities and materials for PE, recess and other parts of the curricular: initiate activities during the school day. These activities are aimed at all children and conducted during PE, recess and other parts of the curriculum and school day. 4. Targeted program for children with special needs/challenges: informed by the model of school change developed by the World Health Organisation and used in a number of mental health intervention projects. It uses a whole-school approach while being aware of students with special needs.
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Primary Outcome(s)
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Physical self-perception measured using the Children’s Physical Self-Perception Profile (C-PSPP) and the Self-Perception Profile for children (SPPC) . Measurements are carried out 08/2015 and 06/2015 by online survey.
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Secondary Outcome(s)
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Measured in 08/2015 and 06/2016 by online survey: 1. General well-being (Kidscreen-27) 2. Physical Activity Self-Efficacy Scale (PASES) 3. Physical Activity Enjoyment Scale (S-PACES)
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Source(s) of Monetary Support
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TrygFonden (Denmark)
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Ethics review
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Status:
Approval date:
Contact:
Conforming to current legislation, the project was submitted to The Regional Scientific Ethical Committees for Southern Denmark. The committee decided that the project was exempt from the obligation to notify. Notification of this decision was forwarded via email 02/04/2014.
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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01/03/2017 |
URL:
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