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

NCT ID: NCT06341179

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-13
• Study Completion Date: 2028-12-31

Brief 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. 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

Sleep Duration; Child Obesity; Child Development; Child Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sleep extension

The 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.

Group Type: EXPERIMENTAL

Sleep extension

Intervention Type: BEHAVIORAL

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.

Control

The 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sleep extension

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk Foundation (NNF)

UNKNOWN

Sponsor Role: collaborator

Faculty of Health, Medicine and Life Sciences, Maastricht University

UNKNOWN

Sponsor Role: collaborator

Center for Obesity Research & Education, Temple University

UNKNOWN

Sponsor Role: collaborator

Danish Research Centre for Magnetic Resonance

OTHER

Sponsor Role: collaborator

University of Southern Denmark

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Faidon Magkos, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen, Department of Nutrition, Exercise and Sports

Locations

University of Copenhagen

Copenhagen, , Denmark

Site Status: RECRUITING

University of Copenhagen

Copenhagen, , Denmark

Site Status: RECRUITING

Faidon Magkos

Hvidovre, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Faidon Magkos, PhD

Role: CONTACT

fma@nexs.ku.dk

+45 35 33 36 71

Eva Leedo-Townend, MSc

Role: CONTACT

elt@nexs.ku.dk

+45 35 33 35 68

Facility Contacts

Faidon Magkos, PhD

Role: primary

fma@nexs.ku.dk

+45 35 33 36 71

Eva Leedo-Townend, MSc

Role: backup

elt@nexs.ku.dk

+45 35 33 35 68

Faidon Magkos, PhD

Role: primary

fma@nexs.ku.dk

+45 35 33 36 71

Jesper Lundbye-Jensen, PhD

Role: backup

jlundbye@nexs.ku.dk

+45 35 32 73 30

Faidon Magkos, PhD

Role: primary

fma@nexs.ku.dk

+45 35 33 36 71

Other Identifiers

H-23063352

Identifier Type: OTHER

Identifier Source: secondary_id

M2S

Identifier Type: -

Identifier Source: org_study_id