Impact of extra sleep on overweight children and their learning

A Randomized Controlled Trial of Sleep Extension to Regulate Body Weight and Improve Learning in School-aged Children

This study is testing if giving extra sleep to mildly overweight children aged 6-9 can help them learn better and manage their weight.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 142 (estimated)
• Ages: 6 Years to 12 Years
• Sex: All
• Sponsor: University of Copenhagen (other)
• Locations: 3 sites (Copenhagen and 2 other locations)
• Trial ID: NCT06341179 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are children aged 6-9 years who are mildly overweight or obese and sleep less than the recommended duration.

Not a fit: Patients with chronic conditions affecting growth, metabolism, or sleep disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved weight management and cognitive development in children.

How similar studies have performed: Previous studies have indicated that improving sleep duration can positively impact weight management and cognitive function, suggesting potential success for this approach.

Eligibility criteria

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 this trial is running

Copenhagen and 2 other locations

• 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

Conditions: Sleep Duration, Child Obesity, Child Development, Child Behavior, Sleep duration, Sleep quality, Overweight and Obesity, Energy Intake