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

NCT06341179 | Recruiting

• 2 other identifiers: M2SH-23063352
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 3

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

Keywords

Sleep duration; Sleep quality; Overweight and Obesity; Energy Intake; Child Development and Behavior; Well-being; Cognitive Function; Learning Ability; Memory

Outcome Measures

Primary Outcomes (3)

• 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

  Assessed at months 0, 3 and 9

• 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)

  Assessed at months 0 and 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)

  Assessed at months 0 and 3

Secondary Outcomes (26)

• Body fat percent

  Assessed at months 0, 3 and 9

• Total fat mass (FM)

  Assessed at months 0, 3 and 9

• Total lean mass (LM)

  Assessed at months 0, 3 and 9

• Bone mineral content (BMC)

  Assessed at months 0, 3 and 9

• Bone mineral density (BMD)

  Assessed at months 0, 3 and 9

Other Outcomes (49)

• Health-related quality of life: child-reported

  Assessed at months 0, 3 and 9

• Health-related quality of life: parent-reported

  Assessed at months 0, 3 and 9

• Mental health: parent-reported

  Assessed at months 0, 3 and 9

Study Arms (2)

Sleep extension

EXPERIMENTAL

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.

Behavioral: Sleep extension

Control

NO INTERVENTION

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.

Interventions

Sleep extension 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.

Sleep extension

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Copenhagen: lead
• Novo Nordisk Foundation (NNF): collaborator
• Faculty of Health, Medicine and Life Sciences, Maastricht University: collaborator
• Center for Obesity Research & Education, Temple University: collaborator
• Danish Research Centre for Magnetic Resonance: collaborator
• University of Southern Denmark: collaborator

Study Sites (3)

University of Copenhagen

Copenhagen, 1958, Denmark

RECRUITING

University of Copenhagen

Copenhagen, 2200, Denmark

RECRUITING

Faidon Magkos

Hvidovre, 2650, Denmark

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity; Child Behavior; Sleep Initiation and Maintenance Disorders; Overweight; Obesity; Behavior

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Faidon Magkos, PhD

  University of Copenhagen, Department of Nutrition, Exercise and Sports

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: April 2, 2024
• Study Start: August 13, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 25, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)