Effect of Sleep Extension on Overweight and Learning in Children

Last updated: January 10, 2025
Sponsor: University of Copenhagen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Hypertriglyceridemia

Treatment

Sleep extension

Clinical Study ID

NCT06341179
M2S
H-23063352
  • Ages 6-9
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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 Criteria

Inclusion

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) usingreference standards from the World Health Organization.

  • Sleep duration: sleeping ≤9 h/night on the basis of sleep diaries filled in by thechildren's parents, based on recommendations by the American Academy of SleepMedicine and the Sleep Health Foundation.

Exclusion

Exclusion Criteria:

  • Any genetic or chronic condition that affects growth, metabolism, eating behaviors,cognitive function, or body weight (for example: dwarfism, epilepsy, attentiondeficit hyperactivity disorder, β-thalassemia, hypo-/hyper-thyroidism, type Idiabetes).

  • 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 studyout-comes.

  • Irregular school schedule or not consistently sleeping in the same household duringthe school week.

  • Participation in other research studies.

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Sleep extension
Phase:
Study Start date:
August 13, 2024
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • University of Copenhagen

    Copenhagen, 1958
    Denmark

    Active - Recruiting

  • Faidon Magkos

    Hvidovre, 2650
    Denmark

    Active - Recruiting

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