- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03906851
Active and Healthy Kids in Telemark - a School Based Health Promoting Intervention
Effects of a School Based Health Promoting Intervention With Physical Activity and Nutrition Among 8th Graders in Telemark
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Telemark
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Bø, Telemark, Norway, 3800
- University College of Southeast Norway
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pupil 8th grade
Exclusion Criteria:
- Inadequate language skills to complete questionnaire
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Activity and diet
Multi-component, holistic model with a) physical activity, b) nutrition, and c) psychosocial work. A: physical activity will be provided as a pedagogical tool in subjects Mathematics, Norwegian and English B: Focus on school meals and menus in school cafeteria C: Psychosocial work with focus on the associations between physical activity, nutrition and psychosocial health. Collaboration between schools and school health services |
Physical activity: use of physical activity in theoretical subjects (3 x 30 min/week), physically active breaks (5 x 5 min/week), physical education (2 x 45 min/week) Nutrition: focus on school meals
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No Intervention: Control
Schools are required to perform teaching activities, school meals and school cafeteria menus as usual
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical activity (counts per minute)
Time Frame: 4 days
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Objectively assessment of physical activity by accelerometer Actigraph GT3x
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4 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical fitness: Andersen test
Time Frame: 10 minutes
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Andersen test to measure endurance capacity, running test on 20 m track for 10 minutes.
Number of metres ran during the 10 minutes is registered.
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10 minutes
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Physical fitness: standing long jump
Time Frame: 2 minutes
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Standing long jump to measure explosive strength.
Each subject gets two trials.
Longest trial is registered in cm.
|
2 minutes
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Nutrition and diet: questionnaire
Time Frame: 5 minutes
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self-report through own-developed questionnaire (not standardised scale)
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5 minutes
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Health-related Quality of Life
Time Frame: 10 minutes
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KIDSCREEN-27 (unabbreviated name) is a 27 item self-report instrument for health-related quality of life in children and adolescents.
Each item is scored on a Likert scale from 1 to 5. The scores of each item are clustered into five dimensions: Physical Well-Being, Psychological Well-Being, Autonomy & Parents, Peers & Social Support and School Environment.
Each dimension, or subscale, is scored as Rasch scales (i.e., sum of item scores for each subscale, transform the raw sumscores into Rasch person parameter estimates and T-values according to the KIDSCREEN-27 manual (KIDSCREEN group Europe, 2006)).
For all these dimensions, higher Rasch scores and T-scores indicate better quality of life according to that given dimension.
|
10 minutes
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Academic performance: grades in subjects Norwegian, mathematics and English
Time Frame: 45 minutes
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Results from national tests which assess level of academic performance among the pupils
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45 minutes
|
Collaborators and Investigators
Investigators
- Study Chair: Solfrid Bratland-Sanda, PhD, University College of Southeast Norway
Publications and helpful links
General Publications
- Penedo FJ, Dahn JR. Exercise and well-being: a review of mental and physical health benefits associated with physical activity. Curr Opin Psychiatry. 2005 Mar;18(2):189-93. doi: 10.1097/00001504-200503000-00013.
- Naylor PJ, Nettlefold L, Race D, Hoy C, Ashe MC, Wharf Higgins J, McKay HA. Implementation of school based physical activity interventions: a systematic review. Prev Med. 2015 Mar;72:95-115. doi: 10.1016/j.ypmed.2014.12.034. Epub 2015 Jan 6.
- Mura G, Vellante M, Nardi AE, Machado S, Carta MG. Effects of School-Based Physical Activity Interventions on Cognition and Academic Achievement: A Systematic Review. CNS Neurol Disord Drug Targets. 2015;14(9):1194-208. doi: 10.2174/1871527315666151111121536.
- Ho FK, Louie LH, Chow CB, Wong WH, Ip P. Physical activity improves mental health through resilience in Hong Kong Chinese adolescents. BMC Pediatr. 2015 Apr 22;15:48. doi: 10.1186/s12887-015-0365-0.
- Ravens-Sieberer, U. and K.G. Europe, The Kidscreen Questionnaires: Quality of Life Questionnaires for Children and Adolescents ; Handbook. 2006: Pabst Science Publ.
- Bratland-Sanda S, Schmidt SK, Reinboth MS, Vrabel KA. Under pressure to exercise: a cross-sectional study of characteristics and predictors of compulsive exercise in early adolescents. J Eat Disord. 2022 Nov 5;10(1):156. doi: 10.1186/s40337-022-00686-8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ACTIKIDS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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