About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Sleep extension
Treatment groups
Sponsors and collaborators
University of Copenhagen
Lead sponsor
Novo Nordisk Foundation (NNF)
Collaborator
Faculty of Health, Medicine and Life Sciences, Maastricht University
Collaborator
Center for Obesity Research & Education, Temple University
Collaborator
Danish Research Centre for Magnetic Resonance
Collaborator
University of Southern Denmark
Collaborator