Clinical trial NCT06341179: Effect of Sleep Extension on Overweight and Learning in Children
Official title: A Randomized Controlled Trial of Sleep Extension to Reduce Overweight and Improve Learning in Prepubescent Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Novo Nordisk Foundation (NNF)
name: Faculty of Health, Medicine and Life Sciences, Maastricht University
name: Center for Obesity Research & Education, Temple University
name: Danish Research Centre for Magnetic Resonance
name: University of Southern Denmark
First posted: 2024-04-02
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: More2Sleep is a randomized, controlled, parallel trial with two groups (sleep extension vs control) including 300 school-aged children (6-9 years) who are mildly overweight or obese 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=150).

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 are overweight or obese, and sleep less than recommended for their age.


Eligibility criteria: Inclusion Criteria:

* Age: 6-9 years old (inclusive range).
* Weight status: modestly overweight or obese (equivalent adult BMI of 25 to 35 kg/m2) defined as a sex-specific BMI Z-score between +1 and +3 (inclusive range) using reference standards from the World Health Organization.
* 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 or chronic condition that affects growth, metabolism, eating behaviors, cognitive function, or body weight (for example: dwarfism, epilepsy, attention deficit hyperactivity disorder, β-thalassemia, hypo-/hyper-thyroidism, 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 out-comes.
* Irregular school schedule or not consistently sleeping in the same household during the school week.
* Participation in other research studies.

Primary outcomes:
measure: BMI Z-score
timeFrame: Assessed at months 0, 3 and 9
measure: Learning ability: skill learning
timeFrame: Assessed at months 0 and 3
measure: Learning ability: Explicit memory
timeFrame: Assessed at months 0 and 3
Secondary outcomes:
measure: Body fat percent
timeFrame: Assessed at months 0, 3 and 9
measure: Total fat mass (FM)
timeFrame: Assessed at months 0, 3 and 9
measure: Total lean mass (LM)
timeFrame: Assessed at months 0, 3 and 9
measure: Bone mineral content (BMC)
timeFrame: Assessed at months 0, 3 and 9
measure: Bone mineral density (BMD)
timeFrame: Assessed at months 0, 3 and 9
measure: Dietary energy intake
timeFrame: Assessed at months 0, 3 and 9
measure: Dietary protein, carbohydrate, fiber, and fat intakes
timeFrame: Assessed at months 0, 3 and 9
measure: Subjective hunger
timeFrame: Assessed at months 0 and 3
measure: Physical activity (PA) time: total PA and MVPA
timeFrame: Assessed at months 0, 1.5,3 and 9
measure: Resting metabolic rate (RMR)
timeFrame: Assessed at months 0 and 3
measure: Thermic effect of food (TEF)
timeFrame: Assessed at months 0 and 3
measure: Weight
timeFrame: Assessed at months 0, 3 and 9
measure: Height
timeFrame: Assessed at months 0, 3 and 9
measure: Total energy expenditure (TEE)
timeFrame: Assessed at months 0 and 3
measure: Fasting and postprandial glucose concentration
timeFrame: Assessed at months 0 and 3
measure: Fasting and postprandial insulin concentration
timeFrame: Assessed at months 0 and 3
measure: Fasting and postprandial total, HDL and LDL cholesterol concentrations
timeFrame: Assessed at months 0 and 3
measure: Fasting and postprandial triglyceride concentration
timeFrame: Assessed at months 0 and 3
measure: Fasting and postprandial C-reactive protein concentration
timeFrame: Assessed at months 0 and 3
measure: Fasting and postprandial tumor necrosis factor alpha concentration
timeFrame: Assessed at months 0 and 3
measure: Fasting and postprandial ghrelin concentration
timeFrame: Assessed at months 0 and 3
measure: Fasting and postprandial leptin concentration
timeFrame: Assessed at months 0 and 3
measure: Fasting and postprandial glucagon like peptide 1 concentration
timeFrame: Assessed at months 0 and 3
measure: Fasting and postprandial peptide YY concentration
timeFrame: Assessed at months 0 and 3
measure: Fasting and postprandial cholecystokinin concentration
timeFrame: Assessed at months 0 and 3
measure: Fasting and postprandial interleukin 6 concentration
timeFrame: Assessed at months 0 and 3
measure: Cognitive functions: processing speed
timeFrame: Assessed at months 0, 3 and 9
measure: Cognitive functions: Sustained attention
timeFrame: Assessed at months 0, 3 and 9
measure: Cognitive functions: Spatial working memory
timeFrame: Assessed at months 0, 3 and 9
measure: Cognitive functions: Inhibitory control
timeFrame: Assessed at months 0, 3 and 9
measure: Cognitive functions: Cognitive flexibility
timeFrame: Assessed at months 0, 3 and 9
measure: School performance: mathematics performance
timeFrame: Assessed at months 0, 3 and 9
measure: School performance: reading comprehension
timeFrame: Assessed at months 0, 3 and 9
measure: Neurophysiological Measurement 1 - ERP Amplitude
timeFrame: Assessed at months 0 and 3
measure: Neurophysiological Measurement 2 - Cortical activity during skill learning
timeFrame: Assessed at months 0 and 3
measure: Neurophysiological Measurement 3 - Muscle activity during skill learning
timeFrame: Assessed at months 0 and 3
measure: Neurophysiological Measurement 4 - corticocortical functional connectivity
timeFrame: Assessed at months 0 and 3
measure: Neurophysiological Measurement 5 - corticomuscular connectivity
timeFrame: Assessed at months 0 and 3
Other outcomes:
measure: Health-related quality of life: child-reported
timeFrame: Assessed at months 0, 3 and 9
measure: Health-related quality of life: parent-reported
timeFrame: Assessed at months 0, 3 and 9
measure: Mental health: parent-reported
timeFrame: Assessed at months 0, 3 and 9
measure: Parental Stress Scale: parent-reported
timeFrame: Assessed at months 0, 3 and 9
measure: Perceived Stress Scale: child-reported
timeFrame: Assessed at months 0, 3 and 9
measure: Demographics: income
timeFrame: Assessed at month 0
measure: Demographics: education
timeFrame: Assessed at month 0
measure: Wakefulness
timeFrame: Assessed at months 0, 3 and 9
measure: Handedness
timeFrame: Assessed at month 0
measure: Fine Motor Control
timeFrame: Assessed at months 0, 3 and 9
measure: Muscle strength
timeFrame: Assessed at months 0, 3 and 9
measure: Brain myelination
timeFrame: Assessed at months 0 and 3
measure: Brain structural connectivity and microstructure
timeFrame: Assessed at months 0 and 3
measure: Brain functional connectivity
timeFrame: Assessed at months 0 and 3
measure: Vital signs: blood pressure
timeFrame: Assessed at months 0, 3 and 9
measure: Vital signs: heart rate
timeFrame: Assessed at months 0, 3 and 9
measure: Vital signs: temperature
timeFrame: Assessed at months 0, 3 and 9
measure: Sleep quality: self-reported sleep duration
timeFrame: Assessed at months 0, 3 and 9
measure: Sleep quality: self-reported latency
timeFrame: Assessed at months 0, 3 and 9
measure: Sleep quality: self-reported awakenings
timeFrame: Assessed at months 0, 3 and 9
measure: Sleep quality: self-reported tiredness/sleepiness
timeFrame: Assessed at months 0, 3 and 9
measure: Sleep quality and architecture: Sleep stages
timeFrame: Assessed at months 0 and 3
measure: Sleep quality and architecture: sleep duration
timeFrame: Assessed at months 0 and 3
measure: Sleep quality and architecture: sleep latency
timeFrame: Assessed at months 0 and 3
measure: Sleep quality and architecture: awakenings
timeFrame: Assessed at months 0 and 3
measure: Sleep quality and architecture: arousals
timeFrame: Assessed at months 0 and 3
measure: Sleep: duration
timeFrame: Assessed at months 0, 1.5,3 and 9
measure: Sleep: movements
timeFrame: Assessed at months 0, 1.5,3 and 9
measure: Sleep: awakenings
timeFrame: Assessed at months 0, 1.5,3 and 9
measure: Brain structure: cortical thickness
timeFrame: Assessed at months 0 and 3
measure: Brain structure: volume
timeFrame: Assessed at months 0 and 3
measure: Brain structure: Surface
timeFrame: Assessed at months 0 and 3
measure: Brain structure: volumes of subcortical grey matter structures
timeFrame: Assessed at months 0 and 3
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
city: Copenhagen
country: Denmark
facility: University of Copenhagen
city: Hvidovre
country: Denmark
facility: Faidon Magkos
Study officials:
affiliation: University of Copenhagen, Department of Nutrition, Exercise and Sports
name: Faidon Magkos, PhD
role: PRINCIPAL_INVESTIGATOR
References: