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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
142
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.
University of Copenhagen
Copenhagen, Denmark
RECRUITINGUniversity of Copenhagen
Copenhagen, Denmark
RECRUITINGFaidon Magkos
Hvidovre, Denmark
RECRUITINGBMI 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 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)
Time frame: 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)
Time frame: Assessed at months 0 and 3
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 9
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 9
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 9
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 9
Bone mineral density (BMD)
Areal BMD (in grams/cm\^2) will be measured by a whole-body dual-energy X-ray absorptiometry (DXA) scan
Time frame: Assessed at months 0, 3 and 9
Dietary energy intake
Daily energy intake (in kcal/day) will be assessed with a three-day 24-hour recall interview on www.myfood24.org (daily averages will be computed)
Time frame: Assessed at months 0, 3 and 9
Dietary protein, carbohydrate, fiber, and fat intakes
Macronutrient intakes (in grams/day) will be assessed with a three-day 24-hour recall interview on www.myfood24.org (daily averages will be computed)
Time frame: Assessed at months 0, 3 and 9
Subjective hunger
Subjective level of hunger (range: from "very hungry" = 1 to "not hungry at all" = 5) in the fasting state and at 1 and 2 hours after a standardized breakfast will be measured by using an image-based visual analog scale (VAS)
Time frame: Assessed at months 0 and 3
Physical activity (PA) time: total PA and MVPA
The time (in min/day) spent being physically active regardless of intensity (total PA) and the time (in min/day) spent on moderate-to-vigorous-physical-activities (MVPA) will be measured for 7 consecutive days (daily averages will be computed) using a wrist-worn triaxial accelerometer
Time frame: Assessed at months 0, 1.5,3 and 9
Resting metabolic rate (RMR)
RMR (in kcal/day) will be measured with indirect calorimetry (canopy mode) the morning after an overnight fast (at least 8 hours)
Time frame: Assessed at months 0 and 3
Thermic effect of food (TEF)
TEF (in kcal) will be computed as the incremental area under the curve (above RMR) for postprandial energy expenditure (measured by indirect calorimetry) for 2 hours after consuming a standardized breakfast
Time frame: Assessed at months 0 and 3
Weight
Body mass (in kg) will be measured on a digital scale to the nearest 0.1 kg
Time frame: Assessed at months 0, 3 and 9
Height
Stature (in cm) will be measured using a wall-mounted stadiometer to the nearest 0.1 cm
Time frame: Assessed at months 0, 3 and 9
Total energy expenditure (TEE)
TEE (in kcal/day) will be measured by using the doubly labelled water method (8 urine samples over 2 weeks)
Time frame: Assessed at months 0 and 3
Cognitive functions: Sustained attention
Performance in neuropsychological assessment of sustained attention ability assessed as errors during a sustained test procedure, CANTAB test battery.
Time frame: Assessed at months 0, 3 and 9
Cognitive functions: Spatial working memory
Performance in neuropsychological assessment of spatial working memory assessed as errors and strategy during the test procedure (Cambridge Neuropsychological Test Automated Battery, Cambridge cognition, UK).
Time frame: Assessed at months 0, 3 and 9
Cognitive functions: Inhibitory control
Performance in neuropsychological assessment of inhibitory control assessed as errors during the test procedure (Modified Eriksen Flanker test, Psychology Software Tools, US) and Cambridge Neuropsychological Test Automated Battery, Cambridge cognition, UK)
Time frame: Assessed at months 0, 3 and 9
Cognitive functions: Cognitive flexibility
Performance in neuropsychological assessment of cognitive flexibility assessed as errors during the test procedure (Cambridge Neuropsychological Test Automated Battery, Cambridge cognition, UK)
Time frame: Assessed at months 0, 3 and 9
School performance: mathematics performance
Mathematics proficiency will be measured by Hogrefe math test
Time frame: Assessed at months 0, 3 and 9
School performance: reading comprehension
Danish reading proficiency will be measured by Hogrefe reading comprehension test
Time frame: Assessed at months 0, 3 and 9
Neurophysiological Measurement 1 - ERP Amplitude
EEG activity measured as the event-related potential (ERP) amplitude during the modified Eriksen Flanker Test
Time frame: Assessed at months 0 and 3
Neurophysiological Measurement 2 - Cortical activity during skill learning
Cortical activity during skill learning will be measured as EEG power
Time frame: Assessed at months 0 and 3
Neurophysiological Measurement 3 - Muscle activity during skill learning
Muscle activity during skill learning will be measured as electromyography amplitude
Time frame: Assessed at months 0 and 3
Neurophysiological Measurement 4 - corticocortical functional connectivity
Corticocortical functional connectivity will be measured as functional coupling in EEG (scale 0-1)
Time frame: Assessed at months 0 and 3
Neurophysiological Measurement 5 - corticomuscular connectivity
Corticomuscular connectivity will be measured as functional coupling between EEG and EMG during skill learning (0-1)
Time frame: Assessed at months 0 and 3
Eating window
The parents will be asked to note on a checklist when their children start and finish eating on each registration day to estimate the duration of the daily eating window.
Time frame: Assessed at months 0, 3 and 9.
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