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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03906851
Other study ID # ACTIKIDS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2017
Est. completion date December 31, 2021

Study information

Verified date October 2022
Source University of South-Eastern Norway
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study examine possible changes in physical activity, nutrition, and psychosocial health following the intervention "Active and Healthy Kids in Telemark". The intervention schools will received the intervention, whereas the control schools will continue as usual.


Description:

School based, health promoting interventions with focus on increase physical activity and improved nutrition seems to be a good solution to the challenges with low physical activity level, poor physical fitness, poor nutrition and psychosocial health challenges among children and adolescents. Low physical activity levels and physical fitness is recognized as one of the major public health challenges in the 21st century, and it negatively affects cognitive skills and academic performances. Providing school based health promoting interventions makes it easier to reach all children and adolescents regardless of social and cultural background, and hence reduce social inequalities in health.


Recruitment information / eligibility

Status Completed
Enrollment 840
Est. completion date December 31, 2021
Est. primary completion date June 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 14 Years
Eligibility Inclusion Criteria: - Pupil 8th grade Exclusion Criteria: - Inadequate language skills to complete questionnaire

Study Design


Intervention

Behavioral:
Activity and diet
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

Locations

Country Name City State
Norway University College of Southeast Norway Telemark

Sponsors (1)

Lead Sponsor Collaborator
University of South-Eastern Norway

Country where clinical trial is conducted

Norway, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Ravens-Sieberer, U. and K.G. Europe, The Kidscreen Questionnaires: Quality of Life Questionnaires for Children and Adolescents ; Handbook. 2006: Pabst Science Publ.

Outcome

Type Measure Description Time frame Safety issue
Primary Physical activity (counts per minute) Objectively assessment of physical activity by accelerometer Actigraph GT3x 4 days
Secondary Physical fitness: Andersen test 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. 10 minutes
Secondary Physical fitness: standing long jump Standing long jump to measure explosive strength. Each subject gets two trials. Longest trial is registered in cm. 2 minutes
Secondary Nutrition and diet: questionnaire self-report through own-developed questionnaire (not standardised scale) 5 minutes
Secondary Health-related Quality of Life 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
Secondary Academic performance: grades in subjects Norwegian, mathematics and English Results from national tests which assess level of academic performance among the pupils 45 minutes
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