Health BehaviourHOPPLearningNCT02495714
HOPPLearning - Active Learning in Elementary Schools
A study testing Active learning and Dietary councelling in people with Health Behaviour, run by Kristiania University College at 1 site in Norway.
Trial summary
HOPP Learning will be implemented in elementary schools in the Horten municipality and will assess the effect of a combined pedagogical approach, active learning, on a large student population. Students are to increase their amount of physical activity with learning, during a school day by one hour. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behaviour
- What is being tested?
- Active learning and Dietary councelling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,300 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2015to Dec 2023
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students from Grade 1-6 (2015) from all elementary schools in Horten municipality and two schools from Loerenskog and Baerum municipality.
Who cannot join
- Students with psychological and physical disabilities preventing them participating in the tests
- Students afflicted with sickness/disease during the testing period
- Students who do not wish to participate in the test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HOPPLearning - Active Learning in Elementary Schools in Horten Municipality
HOPP Learning will be implemented in elementary schools in the Horten municipality and will assess the effect of a combined pedagogical approach, active learning, on a large student population. Students are to increase their amount of physical activity with learning, during a school day by one hour.
Read the detailed description
Background It has for many decades been a discussion whether the proportion of hours of physical activity should be increased in the Norwegian primary school. In light of the evolution of inactivity, overweight and obesity, both internationally and in Norway, it is now time to implement measures that can provide improved health and preventing lifestyle diseases among children and adolescents. Until now, one in Norwegian society based on the fact that children are active enough in their spare time, with sport as an arena. This assertion has had its validity, but not with the tendency of children are significantly more sedentary than their parents were in their infancy. Thus, the community must take more responsibility. One of the measures is to increase the physical activities offered in primary schools. Then all the children get the opportunity to form healthy habits with regular physical activity.
HOPP Learning will be implemented in elementary schools in the Horten municipality and will assess the effect of a combined pedagogical approach, active learning, on a large student population. Students are to increase their amount of physical activity, during a school day by one hour. To evaluate the effect of HOPP Learning Horten municipality contacted University College of Health Sciences - Campus Kristiania.
Aims The primary aim is to chart and assess the effect of active learning through analysis of dietary intake (Ungkost 2000 questionnaire), quality of life (ILC questionnaire), cognitive tests (computer based measurements of reaction time using Flanker and Stroop test), academic performance (grades in national tests) and physiological factors as activity level (accelerometer measurements), aerobic capacity (Andersen shuttle run test and oxygen uptake), balance (Balance Y-test) and strength (Jamar handgrip). In addition medical variables as blood pressure, peak expiratory flow and blood work (total cholesterol, HDL, iron, feritin, CRP, blood sugar, Hb, Hematocrit, RBC).
Sample The project has a prospective clinical controlled study design and involves seven elementary schools in Horten Municipality with the estimated number of children in 1-6 grade being 1,822. The 12 year olds in the current schools will not be tested when they go over to their respective secondary schools in 2016 so will not participate in the intervention. Similarly, those children who start 1st grade in 2015 not be included in the intervention as they are enrolled in kindergarten during the first round of tests in Spring 2015. Consequently there will be a calculated "drop off" of one school grade per year based on the selection from the initial testing during spring 2015, and from the second round of testing in 2016. Based on an analysis of socioeconomic status between municipalities in Norway, Loerenskog and Baerum municipality has a socioeconomic composition as Horten. Given health inequalities in children are directly related to parents' socioeconomic status, and in particular education, Loerenskog and Baerum municipality were chosen as the control population. Two elementary schools were contacted and agreed to participate as control schools, ca. 500 pupils at each school. Similarly calculated dropout rates will occur at the control school. The total inclusion sample is approximately 2,800 pupils. Inclusion criteria: Students from Grade 1-6 from all elementary schools in Horten municipality and from two control schools. Exclusion criteria: Students with psychological or physical disabilities that prevent them participating in the tests, students afflicted with sickness/disease during the testing period and students who do not wish to participate in the test.
Implementation of the intervention A large activity learning library within reading, mathematics and english within the academic guidelines for grades 1-7 has been established. There is thus a total of 32 sites where it is 510 activities within each step. This means that it is unique exercise sets distributed on grades and subjects the individual teachers will have at least one hour per class they are responsible for every day. The range of exercises are based both on the teachers' own ideas, proposals from the Education directorate and www.skolesekken.no. Horten Municipality has distributed this exercise library to the individual schools. The activity is organized as different activity programs of 15 minutes for each subject they wish to teach.
Combining physical activity and learning (basic subjects) exercise sets are stored in boxes with the accompanying learning tools: a crate for english 1st grade, a crate for English 2nd grade, etc., thus making it easy to begin a lesson by simply bringing a box to each class.
- Conditions
- Health Behaviour
- Being tested
- Active learning, Dietary councelling
- Keywords
- Exercise, Diet, Learning
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active learningBehavioural
Physical activity one hour a day as part of academic learning
Dietary councellingBehavioural
Teaching children and parents about a healthy diet
| Study group | Role | What they receive |
|---|---|---|
| Intervention schools | Experimental | Active Learning; One hour each schoolday of physical Activity as part of academic learning Dietary councelling; teaching children and parents about a healty diet Receives: Behavioral: Active learning; Behavioral: Dietary councelling |
| Control schools | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Academic performance
Change in academic performance due to change in the pedagogic technique using standarised national academic tests
Measured: 72 months
Secondary outcomes (7)
Cognitive ability
Measurements of cognitive ability pre- and post intervention using Eriksen Flanker test and Stroop test
Measured: 72 months
Diet changes
Based on diet information to the parents diet change in the children are measured using a questionnaire Ungkost 2000
Measured: 72 months
Changes in quality of life
The intervention may change QOL. The study is using ILC for parents and children to measure the change
Measured: 72 months
Changes in blood values
Blood values of total cholesterol, HDL, 6-months blood-sugar, Hb, RBC, Haematocrit, ferritin, iron and CRP are measured pre- and post intervention.
Measured: 72 months
General physical capacity
General physical capacity is measured in all participants using Andersen shuttle run test, Jamar handgrip, Balance Y-test and maximal oxygen uptake (1st. grade). Changes are expected due to increased physical activity level.
Measured: 72 months
Cardiovascular risk factors
The change in cardiovascular risk factors during 5 years of intervention is measured using a combination of data from medical tests, physiological tests and questionnaires
Measured: 72 months
Physical activity level
Change in physical activity level due to active learning are measured using Actigraph wGT3X-BT across one week
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Health BehaviourStudies 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
- 2,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristiania University College
- Sponsor type
- University, hospital or other
- Collaborators
- Horten municipality
- Responsible party
- Sponsor
- Investigators
- Per Morten Fredriksen, Professor, Principal investigator, University College of Health Sciences - Campus Kristiania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495714
- Sponsor's protocol ID
- KristianiaUC
- Acronym
- HOPPLearning
- Status last verified
- Jun 2021
- First submitted
- 20 Jun 2015
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
de Onis M, Blossner M, Borghi E. Global prevalence and trends of overweight and obesity among preschool children. Am J Clin Nutr. 2010 Nov;92(5):1257-64. doi: 10.3945/ajcn.2010.29786. Epub 2010 Sep 22.
PubMed 20861173Wedderkopp N, Froberg K, Hansen HS, Andersen LB. Secular trends in physical fitness and obesity in Danish 9-year-old girls and boys: Odense School Child Study and Danish substudy of the European Youth Heart Study. Scand J Med Sci Sports. 2004 Jun;14(3):150-5. doi: 10.1111/j.1600-0838.2004.00365.x.
PubMed 15144354Moller NC, Wedderkopp N, Kristensen PL, Andersen LB, Froberg K. Secular trends in cardiorespiratory fitness and body mass index in Danish children: The European Youth Heart Study. Scand J Med Sci Sports. 2007 Aug;17(4):331-9. doi: 10.1111/j.1600-0838.2006.00583.x. Epub 2006 Aug 10.
PubMed 16903897Tomkinson GR, Olds TS. Secular changes in pediatric aerobic fitness test performance: the global picture. Med Sport Sci. 2007;50:46-66. doi: 10.1159/000101075.
PubMed 17387251Ekelund U, Anderssen SA, Froberg K, Sardinha LB, Andersen LB, Brage S; European Youth Heart Study Group. Independent associations of physical activity and cardiorespiratory fitness with metabolic risk factors in children: the European youth heart study. Diabetologia. 2007 Sep;50(9):1832-1840. doi: 10.1007/s00125-007-0762-5. Epub 2007 Jul 20.
PubMed 17641870Resaland GK, Mamen A, Anderssen SA, Andersen LB. Cardiorespiratory fitness and body mass index values in 9-year-old rural Norwegian children. Acta Paediatr. 2009 Apr;98(4):687-92. doi: 10.1111/j.1651-2227.2008.01181.x. Epub 2009 Jan 5.
PubMed 19133872Resaland GK, Mamen A, Boreham C, Anderssen SA, Andersen LB. Cardiovascular risk factor clustering and its association with fitness in nine-year-old rural Norwegian children. Scand J Med Sci Sports. 2010 Feb;20(1):e112-20. doi: 10.1111/j.1600-0838.2009.00921.x. Epub 2009 Jun 9.
PubMed 19522748Resaland GK, Andersen LB, Mamen A, Anderssen SA. Effects of a 2-year school-based daily physical activity intervention on cardiorespiratory fitness: the Sogndal school-intervention study. Scand J Med Sci Sports. 2011 Apr;21(2):302-9. doi: 10.1111/j.1600-0838.2009.01028.x.
PubMed 19895384Bugge A, Tarp J, Ostergaard L, Domazet SL, Andersen LB, Froberg K. LCoMotion - Learning, Cognition and Motion; a multicomponent cluster randomized school-based intervention aimed at increasing learning and cognition - rationale, design and methods. BMC Public Health. 2014 Sep 18;14:967. doi: 10.1186/1471-2458-14-967.
PubMed 25236478Fedewa AL, Ahn S. The effects of physical activity and physical fitness on children's achievement and cognitive outcomes: a meta-analysis. Res Q Exerc Sport. 2011 Sep;82(3):521-35. doi: 10.1080/02701367.2011.10599785.
PubMed 21957711Tomporowski PD, Davis CL, Miller PH, Naglieri JA. Exercise and Children's Intelligence, Cognition, and Academic Achievement. Educ Psychol Rev. 2008 Jun 1;20(2):111-131. doi: 10.1007/s10648-007-9057-0.
PubMed 19777141Singh A, Uijtdewilligen L, Twisk JW, van Mechelen W, Chinapaw MJ. Physical activity and performance at school: a systematic review of the literature including a methodological quality assessment. Arch Pediatr Adolesc Med. 2012 Jan;166(1):49-55. doi: 10.1001/archpediatrics.2011.716.
PubMed 22213750Brown T, Summerbell C. Systematic review of school-based interventions that focus on changing dietary intake and physical activity levels to prevent childhood obesity: an update to the obesity guidance produced by the National Institute for Health and Clinical Excellence. Obes Rev. 2009 Jan;10(1):110-41. doi: 10.1111/j.1467-789X.2008.00515.x. Epub 2008 Jul 30.
PubMed 18673306van Sluijs EM, McMinn AM, Griffin SJ. Effectiveness of interventions to promote physical activity in children and adolescents: systematic review of controlled trials. Br J Sports Med. 2008 Aug;42(8):653-7.
PubMed 18685076Kriemler S, Meyer U, Martin E, van Sluijs EM, Andersen LB, Martin BW. Effect of school-based interventions on physical activity and fitness in children and adolescents: a review of reviews and systematic update. Br J Sports Med. 2011 Sep;45(11):923-30. doi: 10.1136/bjsports-2011-090186.
PubMed 21836176
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOPPLearning - Active Learning in Elementary Schools in Horten Municipality
- ClinicalTrials.gov ID
- NCT02495714
- Acronym / sponsor ID
- HOPPLearning / KristianiaUC
- Conditions
- Health Behaviour
- Keywords
- Exercise, Diet, Learning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,300 participants (actual)
- Lead sponsor
- Kristiania University CollegeUniversity, hospital or other
- Collaborators
- Horten municipality
- Study start
- Jan 2015
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 13 Jul 2015 (estimated)
- 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.
HOPP Learning will be implemented in elementary schools in the Horten municipality and will assess the effect of a combined pedagogical approach, active learning, on a large student population. Students are to increase their amount of physical activity with learning, during a school day by one hour.
Detailed description
Background It has for many decades been a discussion whether the proportion of hours of physical activity should be increased in the Norwegian primary school. In light of the evolution of inactivity, overweight and obesity, both internationally and in Norway, it is now time to implement measures that can provide improved health and preventing lifestyle diseases among children and adolescents. Until now, one in Norwegian society based on the fact that children are active enough in their spare time, with sport as an arena. This assertion has had its validity, but not with the tendency of children are significantly more sedentary than their parents were in their infancy. Thus, the community must take more responsibility. One of the measures is to increase the physical activities offered in primary schools. Then all the children get the opportunity to form healthy habits with regular physical activity.
HOPP Learning will be implemented in elementary schools in the Horten municipality and will assess the effect of a combined pedagogical approach, active learning, on a large student population. Students are to increase their amount of physical activity, during a school day by one hour. To evaluate the effect of HOPP Learning Horten municipality contacted University College of Health Sciences - Campus Kristiania.
Aims The primary aim is to chart and assess the effect of active learning through analysis of dietary intake (Ungkost 2000 questionnaire), quality of life (ILC questionnaire), cognitive tests (computer based measurements of reaction time using Flanker and Stroop test), academic performance (grades in national tests) and physiological factors as activity level (accelerometer measurements), aerobic capacity (Andersen shuttle run test and oxygen uptake), balance (Balance Y-test) and strength (Jamar handgrip). In addition medical variables as blood pressure, peak expiratory flow and blood work (total cholesterol, HDL, iron, feritin, CRP, blood sugar, Hb, Hematocrit, RBC).
Sample The project has a prospective clinical controlled study design and involves seven elementary schools in Horten Municipality with the estimated number of children in 1-6 grade being 1,822. The 12 year olds in the current schools will not be tested when they go over to their respective secondary schools in 2016 so will not participate in the intervention. Similarly, those children who start 1st grade in 2015 not be included in the intervention as they are enrolled in kindergarten during the first round of tests in Spring 2015. Consequently there will be a calculated "drop off" of one school grade per year based on the selection from the initial testing during spring 2015, and from the second round of testing in 2016. Based on an analysis of socioeconomic status between municipalities in Norway, Loerenskog and Baerum municipality has a socioeconomic composition as Horten. Given health inequalities in children are directly related to parents' socioeconomic status, and in particular education, Loerenskog and Baerum municipality were chosen as the control population. Two elementary schools were contacted and agreed to participate as control schools, ca. 500 pupils at each school. Similarly calculated dropout rates will occur at the control school. The total inclusion sample is approximately 2,800 pupils. Inclusion criteria: Students from Grade 1-6 from all elementary schools in Horten municipality and from two control schools. Exclusion criteria: Students with psychological or physical disabilities that prevent them participating in the tests, students afflicted with sickness/disease during the testing period and students who do not wish to participate in the test.
Implementation of the intervention A large activity learning library within reading, mathematics and english within the academic guidelines for grades 1-7 has been established. There is thus a total of 32 sites where it is 510 activities within each step. This means that it is unique exercise sets distributed on grades and subjects the individual teachers will have at least one hour per class they are responsible for every day. The range of exercises are based both on the teachers' own ideas, proposals from the Education directorate and www.skolesekken.no. Horten Municipality has distributed this exercise library to the individual schools. The activity is organized as different activity programs of 15 minutes for each subject they wish to teach.
Combining physical activity and learning (basic subjects) exercise sets are stored in boxes with the accompanying learning tools: a crate for english 1st grade, a crate for English 2nd grade, etc., thus making it easy to begin a lesson by simply bringing a box to each class.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention schools | Experimental | Behavioral: Active learning, Behavioral: Dietary councellingActive Learning; One hour each schoolday of physical Activity as part of academic learning Dietary councelling; teaching children and parents about a healty diet |
| Control schools | No intervention | –No intervention |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Students from Grade 1-6 (2015) from all elementary schools in Horten municipality and two schools from Loerenskog and Baerum municipality.
Key exclusion criteria (3 listed)
- Students with psychological and physical disabilities preventing them participating in the tests
- Students afflicted with sickness/disease during the testing period
- Students who do not wish to participate in the test
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 |
|---|---|---|
| Active learningPhysical activity one hour a day as part of academic learning | Behavioural | Intervention schools |
| Dietary councellingTeaching children and parents about a healthy diet | Behavioural | Intervention schools |
Primary outcome
Academic performance
Time frame: 72 months
Change in academic performance due to change in the pedagogic technique using standarised national academic tests
7 secondary outcomes
Cognitive ability
Time frame: 72 months
Diet changes
Time frame: 72 months
Changes in quality of life
Time frame: 72 months
Changes in blood values
Time frame: 72 months
General physical capacity
Time frame: 72 months
Cardiovascular risk factors
Time frame: 72 months
Physical activity level
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Background: PubMed 20861173de Onis M, Blossner M, Borghi E. Global prevalence and trends of overweight and obesity among preschool children. Am J Clin Nutr. 2010 Nov;92(5):1257-64. doi: 10.3945/ajcn.2010.29786. Epub 2010 Sep 22.
- Background: PubMed 15144354Wedderkopp N, Froberg K, Hansen HS, Andersen LB. Secular trends in physical fitness and obesity in Danish 9-year-old girls and boys: Odense School Child Study and Danish substudy of the European Youth Heart Study. Scand J Med Sci Sports. 2004 Jun;14(3):150-5. doi: 10.1111/j.1600-0838.2004.00365.x.
- Background: PubMed 16903897Moller NC, Wedderkopp N, Kristensen PL, Andersen LB, Froberg K. Secular trends in cardiorespiratory fitness and body mass index in Danish children: The European Youth Heart Study. Scand J Med Sci Sports. 2007 Aug;17(4):331-9. doi: 10.1111/j.1600-0838.2006.00583.x. Epub 2006 Aug 10.
- Background: PubMed 17387251Tomkinson GR, Olds TS. Secular changes in pediatric aerobic fitness test performance: the global picture. Med Sport Sci. 2007;50:46-66. doi: 10.1159/000101075.
- Background: PubMed 17641870Ekelund U, Anderssen SA, Froberg K, Sardinha LB, Andersen LB, Brage S; European Youth Heart Study Group. Independent associations of physical activity and cardiorespiratory fitness with metabolic risk factors in children: the European youth heart study. Diabetologia. 2007 Sep;50(9):1832-1840. doi: 10.1007/s00125-007-0762-5. Epub 2007 Jul 20.
- Background: PubMed 19133872Resaland GK, Mamen A, Anderssen SA, Andersen LB. Cardiorespiratory fitness and body mass index values in 9-year-old rural Norwegian children. Acta Paediatr. 2009 Apr;98(4):687-92. doi: 10.1111/j.1651-2227.2008.01181.x. Epub 2009 Jan 5.
- Background: PubMed 19522748Resaland GK, Mamen A, Boreham C, Anderssen SA, Andersen LB. Cardiovascular risk factor clustering and its association with fitness in nine-year-old rural Norwegian children. Scand J Med Sci Sports. 2010 Feb;20(1):e112-20. doi: 10.1111/j.1600-0838.2009.00921.x. Epub 2009 Jun 9.
- Background: PubMed 19895384Resaland GK, Andersen LB, Mamen A, Anderssen SA. Effects of a 2-year school-based daily physical activity intervention on cardiorespiratory fitness: the Sogndal school-intervention study. Scand J Med Sci Sports. 2011 Apr;21(2):302-9. doi: 10.1111/j.1600-0838.2009.01028.x.
- Background: PubMed 25236478Bugge A, Tarp J, Ostergaard L, Domazet SL, Andersen LB, Froberg K. LCoMotion - Learning, Cognition and Motion; a multicomponent cluster randomized school-based intervention aimed at increasing learning and cognition - rationale, design and methods. BMC Public Health. 2014 Sep 18;14:967. doi: 10.1186/1471-2458-14-967.
- Background: PubMed 21957711Fedewa AL, Ahn S. The effects of physical activity and physical fitness on children's achievement and cognitive outcomes: a meta-analysis. Res Q Exerc Sport. 2011 Sep;82(3):521-35. doi: 10.1080/02701367.2011.10599785.
- Background: PubMed 19777141Tomporowski PD, Davis CL, Miller PH, Naglieri JA. Exercise and Children's Intelligence, Cognition, and Academic Achievement. Educ Psychol Rev. 2008 Jun 1;20(2):111-131. doi: 10.1007/s10648-007-9057-0.
- Background: PubMed 22213750Singh A, Uijtdewilligen L, Twisk JW, van Mechelen W, Chinapaw MJ. Physical activity and performance at school: a systematic review of the literature including a methodological quality assessment. Arch Pediatr Adolesc Med. 2012 Jan;166(1):49-55. doi: 10.1001/archpediatrics.2011.716.
- 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.
Per Morten Fredriksen, Professor principal investigator
University College of Health Sciences - Campus Kristiania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active learning and Dietary councelling in people with Health Behaviour, run by Kristiania University College 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 3 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: status not confirmed, as of the sponsor's last update on 2 Jun 2021. 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?
Results are not available in the source record.
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?
Academic performance (time frame: 72 months). 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 NCT02495714, which also lists 18 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 2 Jun 2021.