Condition category
Not Applicable
Date applied
31/12/2015
Date assigned
20/01/2016
Last edited
31/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Physical inactivity is a health risk, and is especially common among people with less education. Studies have shown that levels of physical activity tend to decline in adolescence. This study examines whether the Let’s Move It program, developed for vocational schools and especially adolescents with low physical activity, is effective and cost-effective at increasing (or preventing the decline in) physical activity and reducing passive time. The focus is especially on the youth that display low levels of physical activity at the start of the study.

Who can participate?
Students and teachers at six schools in Southern Finland.

What does the study involve?
Schools are matched into pairs and are randomly allocated to either receive the intervention or continue teaching as usual. In the intervention schools, students attend six weekly group sessions to increase physical activity, classroom sitting time is reduced by activity breaks and light equipment, and opportunities for exercise are increased (e.g., via community partnerships, access to school facilities). The intervention also includes a poster campaign and a website.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
Six schools in Southern Finland

When is the study starting and how long is it expected to run for?
January 2015 to May 2017

Who is funding the study?
Ministry of Education and Culture (Finland)
Ministry of Social Affairs and Health (Finland)

Who is the main contact?
Dr Nelli Hankonen
Ms Elisa Kaaja
Mr Matti Heino

Trial website

blogs.helsinki.fi/letsmoveit

Contact information

Type

Scientific

Primary contact

Dr Nelli Hankonen

ORCID ID

Contact details

5th floor
Linna
33014 University of Tampere
Tampere
33014
Finland

Type

Public

Additional contact

Ms Elisa Kaaja

ORCID ID

Contact details

Department of Social Research
Social Psychology
P.O. Box 54
Helsinki
00014
Finland

Type

Scientific

Additional contact

Mr Matti Heino

ORCID ID

Contact details

Department of Social Research
Social Psychology
P.O. Box 54
Helsinki
00014
Finland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Cluster-randomized trial of a school-based multilevel intervention to increase physical activity and reduce sedentary behaviour among older adolescents in vocational secondary schools: 'Let’s Move It'

Acronym

Study hypothesis

We hypothesize that the intervention is effective in increasing physical activity and reducing sedentary behaviour, compared to control group, among girls and boys, both immediately and one year after the intensive intervention (i.e., 2 and 14 months from baseline).
Specifically, as the trial was designed especially for adolescents with low physical activity at baseline, we expect to detect a significant difference in change in physical activity and sedentary behaviour among low-active participants.

Ethics approval

Helsinki and Uusimaa Hospital District, decision number 367/13/03/03/2014

Study design

Cluster-randomised parallel-group trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

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

Condition

Physical activity and sedentary behaviour

Intervention

The design is a cluster-randomised parallel group trial, with school as the unit of randomization, with a no-intervention (standard curriculum/teaching as usual) control group and one intervention arm.

The Let's Move It (LMI) intervention objectives are to increase total physical activity, more specifically: increase moderate-to-vigorous PA (MVPA), decrease time spent in sedentary activities, and introduce more breaks in sitting/lying. The intervention targets Capability, Opportunity and Motivation (COM-B model) to these behaviors, delivered as:
1. Six intracurricular group sessions
2. Activity breaks and sitting reduction practices in classrooms
3. Increased opportunities for PA.

Behavioural science theories (e.g. self-determination theory and self-regulation theory) informed the design of intervention content. More specific description of each follows:
1. Trained facilitators in group sessions as part of health education or a similar course included in the school curriculum, and partly using the Internet. The face-to-face intervention consists of six interactive group sessions, ranging from 45 to 60 minutes each, which have been designed to target social cognitive antecedents of motivation and capability. The program includes behaviour change techniques (BCTs) supporting the change of self-determined motivation but also the progress from motivation to goal setting and self-regulation. The website and workbook contains additional materials.
2. The classroom sitting reduction involves decreasing passive time in classrooms by providing equipment for light-intensity activity, and by training teachers to use active teaching methods and introduce activity breaks during class. The intervention includes behaviour change techniques to support maintenance of changes, drawing from habit theory, as well as the self-determination theory.
3. Enhanced access to PA opportunities include maximising access to existing school PA facilities and increasing collaboration with community sporting groups and/or organisations to provide salient opportunities for students as well as reduced price deals (for leisure-time PA). Also, students are provided with online exercise videos to guide home-based workout tailored to low-active youth and not requiring gear. All activities are supported by internet resources as well as a poster campaign, designed based on Pre-Phase results with an advertisement agency.
The intervention pertains to both the class cluster level (LMI sessions, teacher-led activity breaks in classes) and individual level (tailored goals and action plans), as well as school cluster level (poster campaign, teachers workshop and PA equipment, school intervention team).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Changes in students' physical activity and sedentary behaviour over two months (post-intervention) and 14 months (long-term follow-up), specifically in the following co-primary outcome measures:
1. Moderate-to-vigorous physical activity as measured by 7-day accelerometry
2. Proportion of (and breaks in) passive time (sitting and lying) as measured by 7-day accelerometry
3. Step count, as measured by 7-day accelerometry
4. Self-reported physical activity (as measured by questionnaire)

Secondary outcome measures

Students: fat mass and muscle mass (as measured by bioimpedance), BMI, self-reported fitness, symptoms (e.g. neck and shoulder pain), and hypothesized mediators (e.g. autonomous physical activity motivation, intention, outcome expectations, behaviour change technique use), observed teacher sitting reduction behaviours, symptoms, etc).

Teachers: self-reported sitting reduction activities, hypothesized mediators for behaviour change (e.g., motivation, outcome expectancies, habit, behaviour change technique use), observed student behaviour, support from organization, etc).

Overall trial start date

01/01/2015

Overall trial end date

31/05/2017

Reason abandoned

Eligibility

Participant inclusion criteria

The study will comprise 6 school units in Southern Finland. In the vocational schools within the study region that meet the eligibility criteria, we will invite an equal number of student groups, with the requirement of having the Health Education course catered in the first or second study period after baseline measurement, or a possibility of locating the six Let’s Move It (LMI) student sessions elsewhere in the curriculum. Willing students and teachers are included in the trial.

1. Classes of vocational students in the study year 1 or 2 that can be given 6 sessions of LMI sessions as part of standard curriculum
2. Students in the class and/or attending the class teaching sessions
3. Core class or vocational class teachers whose classes involve a large amount of sitting or static/burdening work positions
4. All students of the included classes participate in the LMI sessions, i.e., the voluntariness involves participation in the research measurements
5. Students of all ages will be invited to take part in the study, but subgroup analyses will be run for those aged 15-19 at baseline

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

1000

Participant exclusion criteria

Classes:
1. Insufficient knowledge of the Finnish language to take part in group interventions and use written materials (i.e., preparatory classes for new immigrants)
2. Classes comprised primarily of adult-age students
3. Classes catering for students with severe physical and mental disabilities

Students:
1. Physical condition hindering taking part in PA or bioimpedance measurement (e.g., pregnancy)

Recruitment start date

09/01/2015

Recruitment end date

24/03/2016

Locations

Countries of recruitment

Finland

Trial participating centre

6 vocational school units
Helsinki, Espoo
00550
Finland

Sponsor information

Organisation

University of Helsinki (Finland)

Sponsor details

Department of Social Research
Unioninkatu 37
PO Box 54
Helsinki
00014
Finland

Sponsor type

University/education

Website

www.helsinki.fi

Funders

Funder type

Government

Funder name

Opetus- ja Kulttuuriministeriö

Alternative name(s)

Ministry of Education and Culture, Finland

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Finland

Funder name

Ministry of Social Affairs and Health (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27229682

Publication citations

Additional files

Editorial Notes

31/05/2016: Publication reference added.