Actively Recruiting
Effect of Sleep Extension on Body Weight and Learning in Children (More2Sleep)
Led by University of Copenhagen · Updated on 2025-11-25
142
Participants Needed
3
Research Sites
228 weeks
Total Duration
On this page
Sponsors
U
University of Copenhagen
Lead Sponsor
N
Novo Nordisk Foundation (NNF)
Collaborating Sponsor
AI-Summary
What this Trial Is About
More2Sleep is a randomized, controlled, parallel trial with two groups (sleep extension vs control) including 142 school-aged children (6-12 years) who have a BMI above average, defined as age- and sex-specific BMI Z-score above zero using WHO reference standards, and habitually sleep for ≤ 9 h/night. Data will be collected before and after a 3-month sleep extension intervention, and after a 6-month follow-up (at months 0, 3, and 9). The collection of data is mainly related to the main study. However, some optional examinations will be conducted on a first come, first serve basis, consisting of substudy-I (metabolic mechanisms, n=60) and substudy-II (learning mechanisms, n=142). The primary objective is to assess the effects of sleep extension by \~45 min/night, achieved by going to bed 60-90 min earlier, on adiposity and learning ability in school-aged children who have a BMI for age and sex above average, and sleep less than recommended for their age.
CONDITIONS
Official Title
Effect of Sleep Extension on Body Weight and Learning in Children (More2Sleep)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 6 and 12 years old (inclusive).
- BMI above average for age and sex based on WHO reference standards.
- Habitual sleep duration of 9 hours or less per night as reported by parent sleep diaries.
You will not qualify if you...
- Presence of genetic, neurological, endocrinological, or psychiatric conditions affecting growth, metabolism, eating, cognition, or body weight.
- Diagnosis of sleep-related disorders such as obstructive sleep apnea, parasomnias, narcolepsy, or restless leg syndrome.
- Regular use of medications that could affect study outcomes.
- Irregular school schedule.
- If parents live separately, a parent must agree to carry out the sleep intervention at their household; otherwise, the child should only sleep at that household on Friday, Saturday, and/or Sunday nights.
- Child or parents unable to speak or understand Danish unless both can communicate in English.
- Participation in other research studies.
- Presence of metal implants or claustrophobia (only for substudy-II).
AI-Screening
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Trial Site Locations
Total: 3 locations
1
University of Copenhagen
Copenhagen, Denmark, 1958
Actively Recruiting
2
University of Copenhagen
Copenhagen, Denmark, 2200
Actively Recruiting
3
Faidon Magkos
Hvidovre, Denmark, 2650
Actively Recruiting
Research Team
F
Faidon Magkos, PhD
CONTACT
E
Eva Leedo-Townend, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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