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

University of Copenhagen

Status: Enrolling

Conditions: Child Development; Child Behavior; Sleep Duration; Child Obesity

Treatments: Behavioral: Sleep extension

Study type: Interventional

Funder types: Other

Identifiers

NCT06341179

H-23063352 (Other Identifier)

M2S

Details and patient eligibility

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.

Enrollment: 142 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 2 patient groups

Sleep extension

Experimental group

Description:

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.

Treatment:

Behavioral: Sleep extension

Control

No Intervention group

Description:

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.