Impact of extra sleep on overweight children and their learning

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of extending sleep duration by approximately 45 minutes per night in mildly overweight or obese children aged 6-9 years who typically sleep less than 9 hours. The study involves a randomized controlled design with two groups: one receiving sleep extension and the other serving as a control. Data will be collected at three time points: before the intervention, after 3 months, and at a 6-month follow-up to assess changes in body weight and learning abilities. Optional substudies will explore metabolic and learning mechanisms in a subset of participants.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age: 6-12 years old (inclusive range).
* Weight status: having a BMI above average, defined as an age- and sex-specific BMI Z-score above zero using reference standards from the WHO.
* Sleep duration: sleeping ≤9 h/night on the basis of sleep diaries filled in by the children's parents, based on recommendations by the American Academy of Sleep Medicine and the Sleep Health Foundation.

Exclusion Criteria:

* Any genetic, neurological, endocrinological or psychiatric condition that affects growth, metabolism, eating behaviors, cognitive function, or body weight (for example: dwarfism, epilepsy, attention deficit hyperactivity disorder, head trauma, β-thalassemia, hypothyroid-ism, hyperthyroidism, type I diabetes).
* Any sleep-related disorder (for example: obstructive sleep apnea, parasomnias, narcolepsy, restless leg syndrome).
* Regular use of prescribed or over-the-counter medications that influence study outcomes.
* Irregular school schedule.
* If a child's parents live separately, the child is allowed to sleep at both households. How-ever, if one of the parents does not wish to carry out the sleep intervention and follow given instructions, then the child should only sleep at their household Friday, Saturday and/or Sunday night.
* In the circumstance where the child does not speak or understand Danish, the child's parents do not have to speak or understand Danish, as long as both parties can speak and understand English.
* Participation in other research studies.
* Metal implants and claustrophobia (only for substudy-II).

Where it's running

• University of Copenhagen
  Copenhagen, Denmark Recruiting
• University of Copenhagen
  Copenhagen, Denmark Recruiting
• Faidon Magkos
  Hvidovre, Denmark Recruiting

Study contacts

• Principal investigator: Faidon Magkos, PhD — University of Copenhagen, Department of Nutrition, Exercise and Sports
• Study coordinator: Faidon Magkos, PhD
• Email: fma@nexs.ku.dk
• Phone: +45 35 33 36 71

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.