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Effect of Sleep Extension on Overweight and Learning in Children

Effect of Sleep Extension on Overweight and Learning in Children

Recruiting
6-9 years
All
Phase N/A

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Overview

More2Sleep is a randomized, controlled, parallel trial with two groups (sleep extension vs control) including 300 school-aged children (6-9 years) who are mildly overweight or obese 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=150).

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 are overweight or obese, and sleep less than recommended for their age.

Eligibility

Inclusion Criteria:

  • Age: 6-9 years old (inclusive range).
  • Weight status: modestly overweight or obese (equivalent adult BMI of 25 to 35 kg/m2) defined as a sex-specific BMI Z-score between +1 and +3 (inclusive range) using reference standards from the World Health Organization.
  • 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 or chronic condition that affects growth, metabolism, eating behaviors, cognitive function, or body weight (for example: dwarfism, epilepsy, attention deficit hyperactivity disorder, β-thalassemia, hypo-/hyper-thyroidism, 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 out-comes.
  • Irregular school schedule or not consistently sleeping in the same household during the school week.
  • Participation in other research studies.

Study details
    Sleep Duration
    Child Obesity
    Child Development
    Child Behavior

NCT06341179

University of Copenhagen

16 May 2024

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