Condition category
Not Applicable
Date applied
20/01/2019
Date assigned
07/05/2019
Last edited
10/05/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
The background of this study is a more pronounced increase in health complaints in Sweden than in other Nordic countries. This acceleration in health complaints is correlated with less physical exercise and school stress (Public Health Agency of Sweden, 2019). Current study aims to answer the question whether or not physical breaks in class can improve student’s physical and mental health and academic results. There is no randomly selection of the participants; therefore, the design of the study is pseudo experimental.

Who can participate?
The study involves 60 students from an upper secondary school are divided into two classes, intervention and control. The control class has higher sport interest than the intervention group but equal in gender and age distribution. All students is as healthy volunteers.

What does the study involve?
The intervention group will have separate classroom prepared for physical low activity breaks of 7 minutes twice in lecture; they will have a rotating schedule of different equipment’s: office bikes; standing tables; sitting balls and yoga matts. The intervention group will also have outdoor walking with listening to pods teaching information of physical importance. The teaching for the control group is lectures as usual, with no access to the intervention classroom.

What are the possible benefits and risks of participating?
There is, therefore no side effects for the control group, but might have beneficial effect for the intervention group, in matter of better mental health; of every day physical movements, academic performance and better social climate in the class.

Where is the study run from?
The study take place in a typical secondary school in minor town of Sweden.

When is the study starting and how long is it expected to run for?
February 2019 to December 2019

Who is funding the study?
This is a governmental funded study from the ministry of education in Sweden.

Who is the main contact?
Dr. Hans O. Lofgren
hans.lofgren@umu.se

Trial website

Contact information

Type

Public

Primary contact

Mr Johannes Skog

ORCID ID

Contact details

Hjortronvagen 19
Falun
79145
Sweden
+46 23-87743
johannes.skog@falun.se

Type

Scientific

Additional contact

Dr Hans Löfgren

ORCID ID

http://orcid.org/0000-0003-2588-0780

Contact details

Child and Adolescent Psychiatry
Institution of Applied Clinical Medicine
Umeå University
Umeå
901 87
Sweden
+46 730 92 97 95
hans.lofgren@umu.se

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Dnr 8.1.2-2018:0029833

Study information

Scientific title

Active and Participating by Innovative Classrooms – a pseudo-experimental study of learning abilities, health, peer involvements and academic self-reflection.

Acronym

APIC

Study hypothesis

Minor physical and self-reflection can improve learning abilities, health and peer involvements.

Ethics approval

Not provided at time of registration

Study design

Phase One: review and development by expert consensus
Phase Two: prospective cohort
Phase Three: non-randomised experimental intervention

Primary study design

Interventional

Secondary study design

Psedo-exerimental non randomised study

Trial setting

Schools

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet.

Condition

General health

Intervention

The current study is planned for three phases that will be conducted over 12 months in total.Phase 1 involves establishing which equipment that are available for new and improved classrooms. Phase 2 involves gathering pre-data from two classes, one intervention group and one control group. Phase 3 involves conducting the intervention by teachers in the experimental classroom over two semesters in a typical upper secondary school in a smaller town in Sweden.

The sample include 60 healthy students of both gender, between 16 and 17 years of age. There is no exclusion criteria other than denying participating in the study. Clear oral- and written information, including the aim, of the study are provided to the participants and their parents. Written consent is the inclusion criteria. The teacher that will collect the data collection is responsible for conducting the interventions and holding the anonymization code-key; he is the study-manager. Application for ethical approve is requested from the ministry of ethical applications.

The intervention encompasses activity breaks in English- and Mathematic lectures in a pre-set classroom with movement stimulating equipment, i.e. Pilates bolls and muscle training rubber bands. One Sofa by the company Lekolar of the model Meeting Point Mr Box 3-sits high back. The high back gives some isolation and privacy for teamwork. One smaller whiteboard, besides the large whiteboard, is for scheduling and as cognitive assistant. Twelve standing tables of Lekolar is aimed to minimize sitting. Twelve balance plates of Lekolar that can be combined with the standing tables is aimed to increase movements in the classroom. Ten office bikes by the company Kinnarps including registration sensors, and magnetic resistance so that the students can study and bicycle at the same time. Finally, fourteen ordinary working places with chairs and desks. The activity breaks are twice in seven minutes, the purpose is that the brain might rest to achieve cognitive improvement, concentration improvement and the sitting still will by pulse activating and joyful peer-participating activities. The students sees the remaining time to the break on a specific countdown clock (Time Timer). To ensure that every student in the intervention group will have minor physical during class, there will be a rotation schedule of six weeks. There will also be lectures by walking, listening to information about the importance of exercise recorded on pods on the gymnastic lectures. For the control group the lectures will continue as usual in usual classrooms. The study manage-teacher will take notes of any diverges from the study protocol.

The outcomes are measured three times, base line measures before intervention, second measure before summer leave and end measure in the end of 2019. Demographic data of age, gender, origin, living conditions, sports activities and time assessment of activity, parental education and occupations, transportation and distance to school. Academic achievements of English and mathematics (grades). The mental health is measured by of “Youth Self Report” (YSR), (Achenbach, 2001) an 112 questions long questionnaire about symptoms of mental health considered gold standard of mental health measurement of youth YSR will provide total scale, subscales of externalization and internalization and subscales of DSM-5 (Diagnostic and Statistical Manual of mental disorders). The social climate of the classes is measured by the “What Happen in My Class –questionnaire” (WHMC) that measure Student cohesiveness, Involvement and Cooperation in a two dimensions, one actual and one preferred. WHMC has 20 statements that the students is asked to assess on a Likert scale ranging from “almost never” to “almost always”. Accelerometers records movements in three phases, each phase is one week from the measures of the questionnaires. The three measurements (T1, T2 and T3) will be statistically analysed by SPSS 25.

The correlation of the demographics, questionnaires and accelerometers of the change between the measure points for each group. The standard deviation of the group’s change will be divided by the difference (of the change) between the groups to get an effect size.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

To be measured at baseline, before summer leave and at the end of 2019:
1. Demographic questions of age, gender, origin, living conditions, sports activities and time assessment of activity, parental education and occupations, transportation and distance to school.
2. Academic achievements of English and mathematics.
3. Mental health will be measured by “Youth Self Report” (YSR), (Achenbach, 2001) a 112 items questionnaire with three answering statements “not true”, “somewhat or sometimes true” and “very true or often true”.
4. The social climate of the classes is measured by the “What Happen in My Class –questionnaire” (WHMC) that measure Student cohesiveness, Involvement and Cooperation in a two dimensions, one actual and one preferred.
5. Physical activity is measured by accelerometers attached to the student’s body for one week, three times during the study. The starting day for each measurement is the day of the questionnaires. Three complement questions address students self-report of leisure time physical activities (The National Board of Health and Welfare, 2011).

Secondary outcome measures

none

Overall trial start date

04/02/2019

Overall trial end date

16/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Student
2. Aged 16-17 years old

Participant type

Healthy volunteer

Age group

Other

Gender

Both

Target number of participants

60

Participant exclusion criteria

none

Recruitment start date

01/09/2019

Recruitment end date

01/09/2019

Locations

Countries of recruitment

Sweden

Trial participating centre

Kristinegymnasiet
Falun kommun Bergmästergatan 32
Falun
79171
Sweden

Sponsor information

Organisation

Umeå university

Sponsor details

Umeå universitet
901 87 Umeå
Umeå
90187
Sweden

Sponsor type

University/education

Website

https://www.umu.se

Funders

Funder type

Government

Funder name

Ministry of Education in Sweden

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The study protocol with be registered with an international research registry (ClinicalTrials.gov) and will be made available in the open access University electronic repository. Results of the study will be disseminated in high profile peer-reviewed scientific journals and relevant academic conferences by the ministry of education. Authorship will include funded co-applicants, project supervisor, according to International Committee of Medical Journal Editors (ICMJE) guidelines.

At the end of the study a report will be submitted to the trial funders with full details of study progress and study findings. It is anticipated that the findings are described by domestic conferences.

IPD sharing statement: the datasets in continuous numeric data in excel format, analysed during the current study will be available upon request from Dr Hans O. Lofgren, hans.lofgren@umu.se of: Youth Self Report (Achenbach 2001); What-is-Happening-in-this-Class? (Aldridge & Fraser, 2000); student’s academic performance; accelerometer data. This data will be accessible from april 2020 for peer-reviewers or scholars that need to replicate the study, under the condition that the identity of the students or exact location (school) will remain anonymous, the purpose of requisition of data must be for research or education only. Data will not be provided for profitable business. Data will be provided for administration cost (including VAT). The participants of the study has given the consent that peer reviewers might revaluate the data.

Intention to publish date

01/06/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

10/05/2019: Internal review.