Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06341179

Recruiting nowNot applicableInterventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age6 Years to 12 Years

SexAll

Healthy volunteersAccepted

ConditionSleep Duration, Child Obesity, Child Development, Child Behavior

Full registry 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).

Treatments and study arms

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.

Primary outcomes

BMI Z-scoreAssessed at months 0, 3 and 9

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

Learning ability: skill learningAssessed at months 0 and 3

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)

Learning ability: Explicit memoryAssessed at months 0 and 3

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)