Academic PerformanceNCT03906851
Active and Healthy Kids in Telemark - a School Based Health Promoting Intervention
A study testing Activity and diet in people with Academic Performance and Physical Fitness, run by University of South-Eastern Norway at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Academic Performance, Physical Fitness, Physical Activity
- What is being tested?
- Activity and diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Pupil 8th grade
Who cannot join
- Inadequate language skills to complete questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a School Based Health Promoting Intervention With Physical Activity and Nutrition Among 8th Graders in Telemark
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.
Read the detailed 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.
- Conditions
- Academic Performance, Physical Fitness, Physical Activity, Nutrition
- Being tested
- Activity and diet
- Keywords
- School, Health, Academic performance, Physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity and dietBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Activity and diet |
| Control | No intervention | Schools are required to perform teaching activities, school meals and school cafeteria menus as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity (counts per minute)
Objectively assessment of physical activity by accelerometer Actigraph GT3x
Measured: 4 days
Secondary outcomes (5)
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.
Measured: 10 minutes
Physical fitness: standing long jump
Standing long jump to measure explosive strength. Each subject gets two trials. Longest trial is registered in cm.
Measured: 2 minutes
Nutrition and diet: questionnaire
self-report through own-developed questionnaire (not standardised scale)
Measured: 5 minutes
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.
Measured: 10 minutes
Academic performance: grades in subjects Norwegian, mathematics and English
Results from national tests which assess level of academic performance among the pupils
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start1 Sep 2017
- Primary completion30 Jun 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Academic PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 840 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South-Eastern Norway
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Solfrid Bratland-Sanda, PhD, Study chair, University College of Southeast Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906851
- Sponsor's protocol ID
- ACTIKIDS
- Status last verified
- Oct 2022
- First submitted
- 19 Jan 2018
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25575800Mura 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.
PubMed 26556088Ho 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.
PubMed 25898349Penedo 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.
PubMed 16639173Ravens-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.
PubMed 36335366
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a School Based Health Promoting Intervention With Physical Activity and Nutrition Among 8th Graders in Telemark
- ClinicalTrials.gov ID
- NCT03906851
- Acronym / sponsor ID
- ACTIKIDS
- Conditions
- Academic Performance, Physical Fitness, Physical Activity, Nutrition
- Keywords
- School, Health, Academic performance, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 840 participants (actual)
- Lead sponsor
- University of South-Eastern NorwayUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Activity and diet | Experimental | Behavioral: Activity and dietMulti-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 |
| Control | No intervention | –Schools are required to perform teaching activities, school meals and school cafeteria menus as usual |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pupil 8th grade
Key exclusion criteria (1 listed)
- Inadequate language skills to complete questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activity and dietPhysical 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 | Behavioural | Activity and diet |
Primary outcome
Physical activity (counts per minute)
Time frame: 4 days
Objectively assessment of physical activity by accelerometer Actigraph GT3x
5 secondary outcomes
Physical fitness: Andersen test
Time frame: 10 minutes
Physical fitness: standing long jump
Time frame: 2 minutes
Nutrition and diet: questionnaire
Time frame: 5 minutes
Health-related Quality of Life
Time frame: 10 minutes
Academic performance: grades in subjects Norwegian, mathematics and English
Time frame: 45 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Background: PubMed 25575800Naylor 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.
- Background: PubMed 26556088Mura 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.
- Background: PubMed 25898349Ho 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.
- Background: PubMed 16639173Penedo 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.
- BackgroundRavens-Sieberer, U. and K.G. Europe, The Kidscreen Questionnaires: Quality of Life Questionnaires for Children and Adolescents ; Handbook. 2006: Pabst Science Publ.
- Derived from this study: PubMed 36335366Bratland-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Solfrid Bratland-Sanda, PhD study chair
University College of Southeast Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity and diet in people with Academic Performance and Physical Fitness, run by University of South-Eastern Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (counts per minute) (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03906851, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.