SmartMoves - a pilot study
| ISRCTN | ISRCTN97975679 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97975679 |
| Protocol serial number | NL43909.029.13 |
| Sponsor | EMGO Institute for Health and Care Research (Netherlands) |
| Funder | EMGO Institute for Health and Care Research, VU University Medical Center (Netherlands) |
- Submission date
- 10/06/2014
- Registration date
- 07/08/2014
- Last edited
- 05/01/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Physical activity (exercise) isnt just good for a child's health. Research has shown that physical education (PE) and physical activity can also improve academic performance. However, to date, there have been few studies looking into the effects of physical activity on the cognitive functioning (for example thinking, remembering, judging, and problem-solving) in children. Furthermore, the effects of prolonged sitting on the cognitive functioning of children has never been properly investigated, or indeed how physical activity (or prolonged sitting) affects childrens cardiometabolic health (i.e. their risk of developing heart disease or diabetes). Here, we are going to look into how feasible it is to set up a study to measure the effect of physical activity on the cognitive functioning of children when at school.
Who can participate?
Dutch speaking, healthy children between the ages of 10 and 13.
What does the study involve?
All participating children eat the same breakfast in the morning. They are then randomly allocated into one of three groups. Those in group A sit for a prolonged period in their classroom at school (all morning). Those in group B also sit in their classroom, but with an active break (where the children do a physical activity) halfway through the morning. Those in group C start the day with a physical activity, then sit down in their classroom with an active break halfway through the morning. Blood samples are taken from all the children just before they eat their breakfast and then at the end of the morning. They all take part in cognitive functioning tests at various times throughout the morning.
What are the possible benefits and risks of participating?
There is very little risk to taking part in this study. Blood samples are collected using a fingerprick method, a commonly used technique with few risks.
Where is the study run from?
Department of Public and Occupational Health, VU University Medical Centre, Amsterdam (Netherlands)
When is the study starting and how long is it expected to run for?
June 2013 to June 2014
Who is funding the study?
EMGO Institute for Health and Care Research (Netherlands)
Who is the main contact?
Dr Amika Singh
a.singh@vumc.nl
Contact information
Scientific
van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
| Phone | +31 (0)20 4448382 |
|---|---|
| a.singh@vumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised pilot study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Physical activity, sitting and cognition a pilot study |
| Study objectives | We hypothesized that both one as well as two bouts of moderate-intensity physical activity would enhance childrens selective attention, with larger effects for repeated bouts, when compared to sitting the whole morning. |
| Ethics approval(s) | Medical Ethics Committee of the VU University Medical Center, Amsterdam (The Netherlands), 17/12/2013 |
| Health condition(s) or problem(s) studied | Physical activity, cognitive functioning |
| Intervention | Group A - prolonged sitting Group B - sitting with an active break halfway the morning Group C - day start with physical activity, then sitting with an active break halfway the morning |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Selective attention according to the TEA-CH test, measured at baseline, after 20, 110, 130 and 220 minutes |
| Key secondary outcome measure(s) |
Fasting blood levels of C-peptide, triglycerides and cholesterol, measured at baseline, after 20, 110, 130 and 220 minutes |
| Completion date | 01/06/2014 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 10 Years |
| Upper age limit | 13 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Aged between 10-13 years 2. Apparently healthy 3. Dutch speaking Children were requested to refrain from any moderate-to-vigorous physical activity (MVPA) for at least 3 days prior to the experiment. |
| Key exclusion criteria | 1. Known physical activity contraindications 2. Major illness/injury (acute or chronic) 3. Physical problems that may limit the ability to perform the experiment Participants will be screened by a health check questionnaire. |
| Date of first enrolment | 01/06/2013 |
| Date of final enrolment | 01/06/2014 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
1081 BT
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2016 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
