NCT03906851

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
840

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2018

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 21, 2023

Status Verified

October 1, 2022

Enrollment Period

2.8 years

First QC Date

January 19, 2018

Last Update Submit

April 20, 2023

Conditions

Academic PerformancePhysical FitnessPhysical ActivityNutrition

Keywords

SchoolHealthAcademic performancePhysical activity

Outcome Measures

Primary Outcomes (1)

  • Physical activity (counts per minute)

    Objectively assessment of physical activity by accelerometer Actigraph GT3x

    4 days

Secondary Outcomes (5)

  • Physical fitness: Andersen test

    10 minutes

  • Physical fitness: standing long jump

    2 minutes

  • Nutrition and diet: questionnaire

    5 minutes

  • Health-related Quality of Life

    10 minutes

  • Academic performance: grades in subjects Norwegian, mathematics and English

    45 minutes

Study Arms (2)

Activity and diet

EXPERIMENTAL

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

Behavioral: Activity and diet

Control

NO INTERVENTION

Schools are required to perform teaching activities, school meals and school cafeteria menus as usual

Interventions

Activity and dietBEHAVIORAL

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

Activity and diet

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Pupil 8th grade

You may not qualify if:

  • Inadequate language skills to complete questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College of Southeast Norway

Bø, Telemark, 3800, Norway

Location

Related Publications (6)

  • 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.

    PMID: 25575800BACKGROUND

  • 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.

    PMID: 26556088BACKGROUND

  • 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.

    PMID: 25898349BACKGROUND

  • 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.

    PMID: 16639173BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 36335366DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

ExerciseDiet

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Solfrid Bratland-Sanda, PhD

    University College of Southeast Norway

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2018

First Posted

April 8, 2019

Study Start

September 1, 2017

Primary Completion

June 30, 2020

Study Completion

December 31, 2021

Last Updated

April 21, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)