Quality of Diet in Preschool Population (NCT04301180) | Clinical Trial Compass
CompletedNot Applicable
Quality of Diet in Preschool Population
Spain130 participantsStarted 2017-04-01
Plain-language summary
Childhood obesity is a problem of high prevalence and repercussions in adulthood. It is mostly due to inadequate life habits, modifiable through preventive strategies. The objective was to evaluate in the medium term the effectiveness of an intervention on adherence to the Mediterranean diet pattern in preschoolers.
Method: Community trial with two groups, in children between 3-5 years. The experimental group conducted a school garden and the usual contents on human body and health were taught in the control. Two schools were selected by cluster sampling, whose first unit of randomization were the educational areas followed by schools. The adaptation to the Mediterranean diet pattern was evaluated using the KIDMED questionnaire and weight, height, BMI and sociodemographic variables were controlled.
Who can participate
Age range
3 Years – 5 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:
* Age between 3 and 5 years
* Oral comprehension of Spanish.
Exclusion Criteria:
* Existence of language barriers in parents defined as not understanding spoken or written Spanish.
* Treatment with glucocorticoids.
* Having chronic diseases that could interfere with somatometry.
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
Change of KIDMED questionnaire
Timeframe: During the procedure; baseline, 1 year and 2 years