Actively Recruiting

Phase Not Applicable
Age: 6Years - 12Years
All Genders
Healthy Volunteers
NCT06341179

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

Age: 6Years - 12Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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.
Not Eligible

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

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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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