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Sleep DurationMore2SleepNCT06341179

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

A study testing Sleep extension in people with Sleep Duration and Child Obesity, run by University of Copenhagen at 3 sites in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 6 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Sleep Duration, Child Obesity, Child Development
What is being tested?
Sleep extension
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
3 sitesDenmark
Study dates
13 Aug 2024to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
  • If a child's parents live separately, the child is allowed to sleep at both households. How-ever, if one of the parents does not wish to carry out the sleep intervention and follow given instructions, then the child should only sleep at their household Friday, Saturday and/or Sunday night.
  • In the circumstance where the child does not speak or understand Danish, the child's parents do not have to speak or understand Danish, as long as both parties can speak and understand English.
  • Participation in other research studies.
  • Metal implants and claustrophobia (only for substudy-II).

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Faidon Magkos, PhD contact

+45 35 33 36 71

fma@nexs.ku.dk

Eva Leedo-Townend, MSc contact

+45 35 33 35 68

elt@nexs.ku.dk

Denmark3 sites, 3 recruiting
  • University of Copenhagen

    Copenhagen, 1958

    Faidon Magkos, PhD, +45 35 33 36 71, fma@nexs.ku.dk

    Eva Leedo-Townend, MSc, +45 35 33 35 68, elt@nexs.ku.dk

    Recruiting
  • University of Copenhagen

    Copenhagen, 2200

    Faidon Magkos, PhD, +45 35 33 36 71, fma@nexs.ku.dk

    Jesper Lundbye-Jensen, PhD, +45 35 32 73 30, jlundbye@nexs.ku.dk

    Recruiting
  • Faidon Magkos

    Hvidovre, 2650

    Faidon Magkos, PhD, +45 35 33 36 71, fma@nexs.ku.dk

    Faidon Magkos, PhD

    Recruiting

Other trials in Denmark

About this study

Official title: A Randomized Controlled Trial of Sleep Extension to Regulate Body Weight and Improve Learning in School-aged Children

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.

Being tested
Sleep extension
Keywords
Sleep duration, Sleep quality, Overweight and Obesity, Energy Intake, Child Development and Behavior, Well-being, Cognitive Function, Learning Ability, Memory
Medical subject headings
Pediatric Obesity, Child Behavior, Sleep Initiation and Maintenance Disorders, Overweight, Obesity, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sleep extensionBehavioural

    The sleep extension group will receive a behavioral intervention focusing on parents putting their children to bed earlier by 60-90 minutes. Previous studies have found this change in daily sleeping routine to be feasible and to result in 40-45 min more actual sleep. Children and their parents will receive a behavioral intervention consisting of 6 sessions, including both in-person and virtual sessions, which will be scheduled based on the family's availability and to accommodate practicalities, e.g., potential sickness or cancellations. The first two sessions will occur at the beginning of the study. These initial sessions will focus on effective behavioral strategies to enhance sleep time, including goal setting (e.g., bedtimes and wake-up times), problem-solving and preplanning, stimulus control (i.e., sleep hygiene recommendations), and positive reinforcement. Subsequent sessions will be planned with the families to occur regularly during the 12-week intervention.

Study groups in NCT06341179
Study groupRoleWhat they receive
Sleep extensionExperimentalThe sleep extension group (n=71) will receive a behavioral intervention focusing on parents putting their children to bed earlier by 60-90 minutes. Parents will be instructed only to alter their children's daily sleeping routine, and not to directly alter their diet and physical activity habits. Children and their parents will receive a behavioral intervention consisting of 6 sessions, including both in-person and virtual sessions, which will be scheduled based on the family's availability and to accommodate practicalities.
Receives: Behavioral: Sleep extension
ControlNo interventionThe control group (n=71) will follow their habitual sleeping schedule. Parents will be instructed not to alter their children's daily sleeping routine, or their diet and physical activity habits. The same number and frequency of meetings (in-person or virtual) and methods of registration of bedtime/wake-up times will be used as in the sleep extension group. These meetings will be educational in nature and focus on general well-being and informing the families about the home registrations of e.g., sleep and dietary intake.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BMI Z-score

    BMI (in kg/m^2) will be calculated from weight and height (secondary outcomes), and the age- and sex-specific BMI Z-score (in units of standard deviation from the reference population mean) will be computed using international (WHO) data

    Measured: Assessed at months 0, 3 and 9

  2. Learning ability: skill learning

    Skill learning ability will be measured as motor memory assessed as 24h retention after skill practice - I.e. total within and between session effect (range: from "low" = 0 to "high" = 100, unitless)

    Measured: Assessed at months 0 and 3

  3. Learning ability: Explicit memory

    Explicit memory assessed as 24h retention after word list memory encoding - I.e. total within and between session effect. Number of correctly recalled words in a 2-minute standardized task (range: from 0 to 20)

    Measured: Assessed at months 0 and 3

Secondary outcomes (26)
  1. Body fat percent

    Body fat in % of total body mass (total fat mass divided by total body weight) will be measured by a whole-body dual-energy X-ray absorptiometry (DXA) scan

    Measured: Assessed at months 0, 3 and 9

  2. Total fat mass (FM)

    Body FM (in grams) will be measured by a whole-body dual-energy X-ray absorptiometry (DXA) scan

    Measured: Assessed at months 0, 3 and 9

  3. Total lean mass (LM)

    Body LM (in grams) will be measured by a whole-body dual-energy X-ray absorptiometry (DXA) scan

    Measured: Assessed at months 0, 3 and 9

  4. Bone mineral content (BMC)

    BMC (in grams) will be measured by a whole-body dual-energy X-ray absorptiometry (DXA) scan

    Measured: Assessed at months 0, 3 and 9

  5. Bone mineral density (BMD)

    Areal BMD (in grams/cm^2) will be measured by a whole-body dual-energy X-ray absorptiometry (DXA) scan

    Measured: Assessed at months 0, 3 and 9

  6. Dietary energy intake

    Daily energy intake (in kcal/day) will be assessed with a three-day 24-hour recall interview on www.myfood24.org (daily averages will be computed)

    Measured: Assessed at months 0, 3 and 9

  7. Dietary protein, carbohydrate, fiber, and fat intakes

    Macronutrient intakes (in grams/day) will be assessed with a three-day 24-hour recall interview on www.myfood24.org (daily averages will be computed)

    Measured: Assessed at months 0, 3 and 9

  8. Subjective hunger

    Subjective level of hunger (range: from "very hungry" = 1 to "not hungry at all" = 5) in the fasting state and at 1 and 2 hours after a standardized breakfast will be measured by using an image-based visual analog scale (VAS)

    Measured: Assessed at months 0 and 3

  9. Physical activity (PA) time: total PA and MVPA

    The time (in min/day) spent being physically active regardless of intensity (total PA) and the time (in min/day) spent on moderate-to-vigorous-physical-activities (MVPA) will be measured for 7 consecutive days (daily averages will be computed) using a wrist-worn triaxial accelerometer

    Measured: Assessed at months 0, 1.5,3 and 9

  10. Resting metabolic rate (RMR)

    RMR (in kcal/day) will be measured with indirect calorimetry (canopy mode) the morning after an overnight fast (at least 8 hours)

    Measured: Assessed at months 0 and 3

  11. Thermic effect of food (TEF)

    TEF (in kcal) will be computed as the incremental area under the curve (above RMR) for postprandial energy expenditure (measured by indirect calorimetry) for 2 hours after consuming a standardized breakfast

    Measured: Assessed at months 0 and 3

  12. Weight

    Body mass (in kg) will be measured on a digital scale to the nearest 0.1 kg

    Measured: Assessed at months 0, 3 and 9

  13. Height

    Stature (in cm) will be measured using a wall-mounted stadiometer to the nearest 0.1 cm

    Measured: Assessed at months 0, 3 and 9

  14. Total energy expenditure (TEE)

    TEE (in kcal/day) will be measured by using the doubly labelled water method (8 urine samples over 2 weeks)

    Measured: Assessed at months 0 and 3

  15. Cognitive functions: Sustained attention

    Performance in neuropsychological assessment of sustained attention ability assessed as errors during a sustained test procedure, CANTAB test battery.

    Measured: Assessed at months 0, 3 and 9

  16. Cognitive functions: Spatial working memory

    Performance in neuropsychological assessment of spatial working memory assessed as errors and strategy during the test procedure (Cambridge Neuropsychological Test Automated Battery, Cambridge cognition, UK).

    Measured: Assessed at months 0, 3 and 9

  17. Cognitive functions: Inhibitory control

    Performance in neuropsychological assessment of inhibitory control assessed as errors during the test procedure (Modified Eriksen Flanker test, Psychology Software Tools, US) and Cambridge Neuropsychological Test Automated Battery, Cambridge cognition, UK)

    Measured: Assessed at months 0, 3 and 9

  18. Cognitive functions: Cognitive flexibility

    Performance in neuropsychological assessment of cognitive flexibility assessed as errors during the test procedure (Cambridge Neuropsychological Test Automated Battery, Cambridge cognition, UK)

    Measured: Assessed at months 0, 3 and 9

  19. School performance: mathematics performance

    Mathematics proficiency will be measured by Hogrefe math test

    Measured: Assessed at months 0, 3 and 9

  20. School performance: reading comprehension

    Danish reading proficiency will be measured by Hogrefe reading comprehension test

    Measured: Assessed at months 0, 3 and 9

  21. Neurophysiological Measurement 1 - ERP Amplitude

    EEG activity measured as the event-related potential (ERP) amplitude during the modified Eriksen Flanker Test

    Measured: Assessed at months 0 and 3

  22. Neurophysiological Measurement 2 - Cortical activity during skill learning

    Cortical activity during skill learning will be measured as EEG power

    Measured: Assessed at months 0 and 3

  23. Neurophysiological Measurement 3 - Muscle activity during skill learning

    Muscle activity during skill learning will be measured as electromyography amplitude

    Measured: Assessed at months 0 and 3

  24. Neurophysiological Measurement 4 - corticocortical functional connectivity

    Corticocortical functional connectivity will be measured as functional coupling in EEG (scale 0-1)

    Measured: Assessed at months 0 and 3

  25. Neurophysiological Measurement 5 - corticomuscular connectivity

    Corticomuscular connectivity will be measured as functional coupling between EEG and EMG during skill learning (0-1)

    Measured: Assessed at months 0 and 3

  26. Eating window

    The parents will be asked to note on a checklist when their children start and finish eating on each registration day to estimate the duration of the daily eating window.

    Measured: Assessed at months 0, 3 and 9.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2024
  2. Study start13 Aug 2024
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
142 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06341179
Sponsor's protocol ID
M2S
Other IDs
H-23063352
Acronym
More2Sleep
Status last verified
Jan 2025
First submitted
10 Aug 2023
Last updated
25 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rasmussen CH, Neesgaard ND, Skriver-Bayer M, Muushardt CS, Leedo-Townend E, Bjorndal JR, Rosenkrans MI, Wulff-Abramsson A, Mejer L, Madsen KS, Johnsen LK, Siebner HR, Debes NM, Hart CN, Plasqui G, Grontved A, Nielsen G, Jennum PJ, Lundbye-Jensen J, Magkos F. Protocol for a randomized controlled trial investigating the effects of sleep extension on body weight and learning in children (More2Sleep). Front Pediatr. 2026 May 11;14:1758117. doi: 10.3389/fped.2026.1758117. eCollection 2026.

    PubMed 42199500

Questions about this trial

What is this clinical trial studying?

A study testing Sleep extension in people with Sleep Duration and Child Obesity, run by University of Copenhagen at 3 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Faidon Magkos, PhD (+45 35 33 36 71, fma@nexs.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BMI Z-score (time frame: Assessed at months 0, 3 and 9). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06341179, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.

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