UnknownNot Applicable

24-h Movement Behaviors and Adherence to the Mediterranean Diet in Children

Spain154 participantsStarted 2022-12-02

Plain-language summary

The purpose of this study is to determine the effects of the Archena Infancia Saludable project on adherence to MD and 24-h movement behaviors in schoolchildren

Who can participate

Age range

6 Years – 13 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: Schoolchildren aged 6-13 years will be eligible Exclusion Criteria: * Participants with any pathology that contraindicate exercise or that request special attention. * Participants under pharmacological treatment that prevent them from receiving the contents of the activities of the program. * Participants or parents/legal guardians presenting Spanish learning difficulties. * Participants do not authorized by the parents/guardians to be included in the research project. * Participants do not agree to take part in the research project.

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

Adherence to the Mediterranean diet

Timeframe: From baseline to 36 weeks later

24-h movement behaviors (accelerometers) sedentary time

Timeframe: From baseline to 36 weeks later

24-h movement behaviors (self-reported)

Timeframe: From baseline to 36 weeks later

24-h movement behaviors (accelerometers) physical activity

Timeframe: From baseline to 36 weeks later

24-h movement behaviors (accelerometers) sleep duration

Timeframe: From baseline to 36 weeks later.

Trial details

NCT IDNCT05620303

SponsorUniversity of Castilla-La Mancha

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-31

View on ClinicalTrials.gov More Mediterranean Diet trials

Who can participate

Age range

6 Years – 13 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.

What they're measuring

Adherence to the Mediterranean diet

Timeframe: From baseline to 36 weeks later

24-h movement behaviors (accelerometers) sedentary time

Timeframe: From baseline to 36 weeks later

24-h movement behaviors (self-reported)

Timeframe: From baseline to 36 weeks later

24-h movement behaviors (accelerometers) physical activity

Timeframe: From baseline to 36 weeks later

24-h movement behaviors (accelerometers) sleep duration

Timeframe: From baseline to 36 weeks later.