Effect of Sleep Extension on Body Weight and Learning in Children (More2Sleep)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorUniversity of Copenhagen

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

142 Participants
are divided into 2 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