Study on the Effect of a Gamified Health Education Programme on Primary School Children (NCT07276412) | Clinical Trial Compass
RecruitingNot Applicable
Study on the Effect of a Gamified Health Education Programme on Primary School Children
Spain500 participantsStarted 2024-09-02
Plain-language summary
This randomised study evaluates the effectiveness of Health Education through a Gamified Health Programme on diet, sedentary behaviour and daily physical activity in primary school children.
Who can participate
Age range
6 Years – 7 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pupils enrolled in primary education at schools in Extremadura.
Exclusion Criteria:
* All pupils diagnosed with special educational needs will be excluded.
* Pupils who join after the programme has started.
* Absence of informed consent signature to participate in the study and use of the BELLOTEX-SALUD application by the child's parents or legal guardians.
* Any condition that, in the opinion of the investigators, would disqualify the subject from participation in the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in weekly physical activity at 12 weeks
Timeframe: 0 and 12 weeks
2
Changes in body fat mass composition over 12 weeks
Timeframe: 0 and 12 weeks
3
Changes in body weight composition over 12 weeks
Timeframe: 0 and 12 weeks
4
Changes in Body Mass Index over 12 weeks
Timeframe: 0 and 12 weeks
5
Changes in the percentage of carbohydrates ingested over 12 weeks
Timeframe: 0 and 12 weeks
6
Changes in the percentage of fat ingested over 12 weeks