Plain English Summary
Background and study aims
Few children engage in sufficient moderate-to-vigorous physical activity at elementary school, despite the related health benefits. Previous studies have identified the most efficient behaviour change methods for influencing physical activity among children. The aim of this study is to test the effect of a program promoting at least 30 minutes of daily school-based physical activity.
Who can participate?
Children in grades 5 and 6 at participating schools
What does the study involve?
Participating schools are randomly allocated to either deliver the physical activity program or the standard curriculum. The physical activity program (IMove30+) is delivered over 14 weeks and includes physical activity, active learning and awareness-raising activities with children, parents and educational staff, as well as monitoring the children’s participation in physical activity. Before and after the program children’s physical activity levels, height, weight and waist, and screen time are measured.
What are the possible benefits and risks of participating?
The children receive personalized follow-up to help them to adopt an active lifestyle, and they contribute to the advancement of knowledge in this field and to the improvement of the interventions offered to the participants. There is an increased risk of injury while taking part in physical activities, but particular attention will be paid to safety during meetings. There is no particular psychological risk associated with this type of study.
Where is the study run from?
Université Laval (Canada)
When is the study starting and how long is it expected to run for?
July 2015 to March 2016
Who is funding the study?
Université Laval (Canada)
Who is the main contact?
Mrs Tania Santina
tanya.santina.1@ulaval.ca
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Tania Santina
ORCID ID
Contact details
Faculty of Nursing
Université Laval
Québec
G1V 0A6
Canada
+1 (0)418 656 2131
tanya.santina.1@ulaval.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2014-274 Phase IV/16-11-2015
Study information
Scientific title
Tackling the trio of intention, perceived control and self-identity for promoting physical activity among girls and boys in elementary school: a quasi-experimental study
Acronym
CRT
Study hypothesis
The primary hypotheses were as follows:
1. Children in the experimental group, including both girls and boys belonging to different BMI classes, would significantly increase their general PA level compared to the control group
2. A larger proportion of children in the experimental group would engage in at least 30 minutes of daily Moderate to Vigorous Physical Activity (MVPA) at school after the intervention (i.e., 14 weeks from baseline) compared to the control group
The secondary hypotheses were that children exposed to the intervention, as compared to the control group, would:
1. Significantly decrease their BMI, waist circumference and screen time
2. Report a significantly higher intention to engage in MVPA at school, demonstrate a higher self-identification as a sporty child and perceive more behavioral control and facilitating factors and fewer barriers
3. Changes in PA level would be moderated or mediated by changes in psychosocial variables
Ethics approval
The ethics board of the Human Research Ethics Committees, 16/11/2015, ref: 2014-274 Phase IV/16-11-2015
Study design
Quasi-experimental study
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Schools
Trial type
Prevention
Patient information sheet
No participant information sheet available
Condition
Promotion of school-based physical activity
Intervention
A quasi-experimental trial was used with pre- and post-intervention measures and two parallel groups: an experimental group (the IMove30+ program) compared with a control group (standard curriculum). Two schools were involved, including all fifth- and sixth-grade classes (17 classes, experimental school k = 9, control school k = 8). These two schools were selected from 11 candidates because these two were similar with regard to the total number of students, the school fees and the education levels offered. The two schools were both secular school with co-education of girls and boys, and both had certified physical education teachers, a school nurse and two recesses lasting 25 minutes each. Both were willing to engage in a reformed curriculum along with school staff activities in order to promote school-based PA. To prevent contamination and for practical reasons, the school was chosen as a unit of randomization. Prior to starting the trial, participating schools were randomly allocated to the intervention and control arms, using a lottery draw.
The IMove30+ program is a school-based intervention promoting at least 30 minutes of daily school-based MVPA among children in elementary school. The program was designed to be offered in an Arabic context over one semester (14 weeks) and repeated as many times as desired. It was developed using the Intervention Mapping process (Bartholomew et al., 2016), which is characterized by the participation of stakeholders (e.g., children, school managers, nurses and teachers) and based on an extensive literature review of the factors influencing children’s PA and of the active components of previous effective programs. Considering that most studies explored factors influencing PA during leisure time (i.e., out of school) among Western countries, an additional survey was conducted in a Lebanese school context and described elsewhere (Santina et al., 2017). Following this survey, 5 determinants of school-based MVPA were identified and used to guide the selection of the behavior change methods used in IMove30+ (Kok et al., 2016): (a) intention (associated behavior change methods: action and coping planning); (b) self-identity (change methods: giving opportunities to perceive oneself as a role model and experiencing valued self-identity); (c) perceived behavioral control; (d) perceived barriers (change methods: behavior adoption facilitation, providing rewards); and (e) gender (change method: providing enjoyable opportunities for girls) (Santina et al., 2017). The program included 8 components:
1. 10 minutes of daily structured MVPA delivered daily by the teacher during academic lessons (i.e., during a short break in the classroom) and comprising motor skill tasks such as jumping
2. 20 minutes of daily structured (e.g., dance, soccer) or unstructured (e.g., Dragon Chain, Tank Assault) MVPA during lunch recess
3. Learning activities on PA based on an assignment booklet used by children (Annexe H)
4. Parental information
5. Educational staff involvement
6. Monitoring system of the children’s participation in PA
7. Events at school (e.g., biking and hiking trips, a PA celebration day)
8. Environmental changes (e.g., updated procedures for using sport equipment, improving the attractiveness of the playground).
Fidelity to program delivery was promoted and successfully achieved through intervention manuals, training and direct observation by a member of the research team. Details on the intervention development and content can be found elsewhere (Santina, Beaulieu, Gagné, & Guillaumie, under review). In the control group, children followed the usual school curriculum during the study period (i.e., one class of 50-minute physical education per week and unsupervised activities during recess).
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Children’s general PA levels, measured by the Physical Activity Questionnaire for Older Children (PAQ-C)
2. Proportion of children engaged in at least 30 minutes of daily Moderate to Vigorous Physical Activity at school during the previous week
Measured at baseline (in December 2015) and at the end of the intervention after 14 weeks (in March 2016)
Secondary outcome measures
1. Anthropometric measures (height, weight and waist circumference) measured in a clinical exam by dieticians
2. Psychosocial variables and screen time, measured using a self-administered questionnaire
Measured at baseline (in December 2015) and at the end of the intervention after 14 weeks (in March 2016)
Overall trial start date
17/07/2015
Overall trial end date
24/03/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Children in grades 5 and 6 in participating schools
2. Signed the child assent form
3. Parent/guardian has signed an informed consent form
Participant type
All
Age group
Child
Gender
Both
Target number of participants
374
Participant exclusion criteria
Children who had a medical condition or physical injury that hindered testing or participation (e.g., cardiovascular or metabolic diseases, asthma or disabilities)
Recruitment start date
21/11/2015
Recruitment end date
25/11/2015
Locations
Countries of recruitment
Lebanon
Trial participating centre
Université Laval
Facuté des sciences infirmières
Québec
G1V 0A6
Canada
Funders
Funder type
University/education
Funder name
Université Laval
Alternative name(s)
Laval University, UL
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
Canada
Results and Publications
Publication and dissemination plan
The manuscript is under review.
IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available due to the parental consent and children assignment forms used.
Intention to publish date
22/10/2018
Participant level data
Not expected to be available
Basic results (scientific)
Publication list