Effect of Sleep Extension on Body Weight and Learning in Children (More2Sleep)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorUniversity of Copenhagen
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Sleep extension
BehavioralThe 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.
Treatment groups
142 Participants
are divided into 2 treatment groupsGroup A: Sleep extensionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
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
Time frame
Assessed at months 0, 3 and 92
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)
Time frame
Assessed at months 0 and 33
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)
Time frame
Assessed at months 0 and 3Secondary outcomes
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
Time frame
Assessed at months 0, 3 and 92
Total fat mass (FM)
Body FM (in grams) will be measured by a whole-body dual-energy X-ray absorptiometry (DXA) scan
Time frame
Assessed at months 0, 3 and 93
Total lean mass (LM)
Body LM (in grams) will be measured by a whole-body dual-energy X-ray absorptiometry (DXA) scan
Time frame
Assessed at months 0, 3 and 94
Bone mineral content (BMC)
BMC (in grams) will be measured by a whole-body dual-energy X-ray absorptiometry (DXA) scan
Time frame
Assessed at months 0, 3 and 9Other outcomes
1
Health-related quality of life: child-reported
The total summary score of health-related quality of life (from 50 to 250), and sub-scale scores (from 10 to 50) of physical well-being, psychological well-being, autonomy and parent relation, peers and social support, and school environment, will be assessed by KIDSCREEN 27 questionnaire
Time frame
Assessed at months 0, 3 and 92
Health-related quality of life: parent-reported
The Health Related Quality of Life score (from 0 to 100), Physical Health Summary score (from 0 to 100) and Psychosocial Health summary score (from 0 to 100) will be assessed by the Pediatric Quality of Life inventory (PedsQL)-Parent report (separate version for 6-7 y and 8-9 years olds)
Time frame
Assessed at months 0, 3 and 93
Mental health: parent-reported
The total difficulties score (from 0 to 40) of the Strengths and Difficulties Questionnaire, as well as sub-scale scores (from 0 to 10) of emotional symptoms, conduct problems, hyperactivity/inattention, relationship problems and prosocial behavior
Time frame
Assessed at months 0, 3 and 94
Parental Stress Scale: parent-reported
Perceived parental stress (from 18 to 90) will be assessed by the Parental Stress Scale questionnaire
Time frame
Assessed at months 0, 3 and 9Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Copenhagen
Lead sponsor
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
Source ClinicalTrials.gov