Child Development Clinical Trial
— More2SleepOfficial title:
A Randomized Controlled Trial of Sleep Extension to Reduce Overweight and Improve Learning in Prepubescent Children
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 9 Years |
Eligibility | 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, ß-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. |
Country | Name | City | State |
---|---|---|---|
Denmark | University of Copenhagen | Copenhagen | |
Denmark | University of Copenhagen | Copenhagen | |
Denmark | Faidon Magkos | Hvidovre |
Lead Sponsor | Collaborator |
---|---|
University of Copenhagen | Center for Obesity Research & Education, Temple University, Danish Research Centre for Magnetic Resonance, Faculty of Health, Medicine and Life Sciences, Maastricht University, Novo Nordisk Foundation (NNF), University of Southern Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | Assessed at months 0, 3 and 9 | |
Other | 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) | Assessed at months 0, 3 and 9 | |
Other | 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 | Assessed at months 0, 3 and 9 | |
Other | Parental Stress Scale: parent-reported | Perceived parental stress (from 18 to 90) will be assessed by the Parental Stress Scale questionnaire | Assessed at months 0, 3 and 9 | |
Other | Perceived Stress Scale: child-reported | Perceived child stress score (from 1 to 39) will be assessed by the PSS-C questionnaire | Assessed at months 0, 3 and 9 | |
Other | Demographics: income | Income level (stepwise increasing from level 1 to 7) will be reported by the parents on a demographics questionnaire | Assessed at month 0 | |
Other | Demographics: education | Education level (stepwise increasing from level 1 to 8) will be reported by the parents on a demographics questionnaire | Assessed at month 0 | |
Other | Wakefulness | Wakefulness (score from "very awake" = 1 to "sleeping" = 8) assessed by Standford Sleepiness Scale | Assessed at months 0, 3 and 9 | |
Other | Handedness | Handedness preference (right or left) will be assessed by asking the children "Which hand do you use to write and draw?" do to determine dominant hand | Assessed at month 0 | |
Other | Fine Motor Control | Fine motor control will be assessed by the pegboard test (score in number of pins placed correctly) | Assessed at months 0, 3 and 9 | |
Other | Muscle strength | Muscular strength of the handgrip will be measured by a handgrip dynamometer (in Newton) | Assessed at months 0, 3 and 9 | |
Other | Brain myelination | Indices of myelination in grey and white matter are estimated using R1 obtained from an MP2RAGE MRI-sequence | Assessed at months 0 and 3 | |
Other | Brain structural connectivity and microstructure | Grey and white matter microstructure will be examined using diffusion-weighted imaging | Assessed at months 0 and 3 | |
Other | Brain functional connectivity | Functional connectivity will be measured using resting-state function MRI (fMRI) | Assessed at months 0 and 3 | |
Other | Vital signs: blood pressure | Systolic and diastolic blood pressure (in mmHg) will be measured at rest by using a automatic sphygmomanometer | Assessed at months 0, 3 and 9 | |
Other | Vital signs: heart rate | Heart rate (in beats per minute, bpm) will be measured at rest by using an automatic sphygmomanometer | Assessed at months 0, 3 and 9 | |
Other | Vital signs: temperature | Body (skin) temperature (in degrees Celsius) will be measured telemetrically in the ear | Assessed at months 0, 3 and 9 | |
Other | Sleep quality: self-reported sleep duration | Sleep duration (hour/night) will be measured by the Scandinavian Sleep Questionnaire (Child and parent-reported). | Assessed at months 0, 3 and 9 | |
Other | Sleep quality: self-reported latency | Latency (minutes) will be measured by the Scandinavian Sleep Questionnaire (Child and parent-reported) | Assessed at months 0, 3 and 9 | |
Other | Sleep quality: self-reported awakenings | Awakenings (number/night) will be measured by the Scandinavian Sleep Questionnaire (Child and parent-reported). | Assessed at months 0, 3 and 9 | |
Other | Sleep quality: self-reported tiredness/sleepiness | Tiredness/sleepiness during the day (yes/no) will be measured by the Scandinavian Sleep Questionnaire (Child and parent-reported). | Assessed at months 0, 3 and 9 | |
Other | Sleep quality and architecture: Sleep stages | Sleep stages (distribution of sleep stages in minutes and percentages of total sleep time) will be measured by polysomnography through a one night sleep period. | Assessed at months 0 and 3 | |
Other | Sleep quality and architecture: sleep duration | Total sleep time (minutes) will be measured by polysomnography through a one night sleep period. | Assessed at months 0 and 3 | |
Other | Sleep quality and architecture: sleep latency | Sleep latency (minutes) will be measured by polysomnography through a one night sleep period. | Assessed at months 0 and 3 | |
Other | Sleep quality and architecture: awakenings | Awakenings (number) will be measured by polysomnography through a one night sleep period. | Assessed at months 0 and 3 | |
Other | Sleep quality and architecture: arousals | Arousals (number per hour) will be measured by polysomnography through a one night sleep period. | Assessed at months 0 and 3 | |
Other | Sleep: duration | Sleep duration (in minutes per night) will be measured by using a wrist-worn triaxial accelerometer for 7 consecutive days (the average will be computed). | Assessed at months 0, 1.5,3 and 9 | |
Other | Sleep: movements | Movements (number) will be measured by using a wrist-worn triaxial accelerometer for 7 consecutive days (the average will be computed). | Assessed at months 0, 1.5,3 and 9 | |
Other | Sleep: awakenings | Awakenings (number) will be measured by using a wrist-worn triaxial accelerometer for 7 consecutive days (the average will be computed). | Assessed at months 0, 1.5,3 and 9 | |
Other | Brain structure: cortical thickness | Cortical thickness (mm) will be measured by a T1-weighted MR-image (MP2RAGE). | Assessed at months 0 and 3 | |
Other | Brain structure: volume | Volume (mm3) will be measured by a T1-weighted MR-image (MP2RAGE). | Assessed at months 0 and 3 | |
Other | Brain structure: Surface | Surface area (mm2) will be measured by a T1-weighted MR-image (MP2RAGE). | Assessed at months 0 and 3 | |
Other | Brain structure: volumes of subcortical grey matter structures | Volumes (mm3) of subcortical grey matter structures will be measured by a T1-weighted MR-image (MP2RAGE). | Assessed at months 0 and 3 | |
Primary | 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 | Assessed at months 0, 3 and 9 | |
Primary | 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) | Assessed at months 0 and 3 | |
Primary | 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) | Assessed at months 0 and 3 | |
Secondary | 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 | Assessed at months 0, 3 and 9 | |
Secondary | Total fat mass (FM) | Body FM (in grams) will be measured by a whole-body dual-energy X-ray absorptiometry (DXA) scan | Assessed at months 0, 3 and 9 | |
Secondary | Total lean mass (LM) | Body LM (in grams) will be measured by a whole-body dual-energy X-ray absorptiometry (DXA) scan | Assessed at months 0, 3 and 9 | |
Secondary | Bone mineral content (BMC) | BMC (in grams) will be measured by a whole-body dual-energy X-ray absorptiometry (DXA) scan | Assessed at months 0, 3 and 9 | |
Secondary | Bone mineral density (BMD) | Areal BMD (in grams/cm^2) will be measured by a whole-body dual-energy X-ray absorptiometry (DXA) scan | Assessed at months 0, 3 and 9 | |
Secondary | 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) | Assessed at months 0, 3 and 9 | |
Secondary | 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) | Assessed at months 0, 3 and 9 | |
Secondary | 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) | Assessed at months 0 and 3 | |
Secondary | 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 | Assessed at months 0, 1.5,3 and 9 | |
Secondary | 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) | Assessed at months 0 and 3 | |
Secondary | 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 | Assessed at months 0 and 3 | |
Secondary | Weight | Body mass (in kg) will be measured on a digital scale to the nearest 0.1 kg | Assessed at months 0, 3 and 9 | |
Secondary | Height | Stature (in cm) will be measured using a wall-mounted stadiometer to the nearest 0.1 cm | Assessed at months 0, 3 and 9 | |
Secondary | Total energy expenditure (TEE) | TEE (in kcal/day) will be measured by using the doubly labelled water method (8 urine samples over 2 weeks) | Assessed at months 0 and 3 | |
Secondary | Fasting and postprandial glucose concentration | The concentration of glucose (in mmol/L) will be measured in blood during fasting and at 2 hours after consuming a standardized breakfast | Assessed at months 0 and 3 | |
Secondary | Fasting and postprandial insulin concentration | The concentration of insulin (in pmol/L) will be measured in blood during fasting and at 2 hours after consuming a standardized breakfast | Assessed at months 0 and 3 | |
Secondary | Fasting and postprandial total, HDL and LDL cholesterol concentrations | The concentrations of total, HDL and LDL cholesterol (in mmol/L) will be measured in blood during fasting and at 2 hours after consuming a standardized breakfast | Assessed at months 0 and 3 | |
Secondary | Fasting and postprandial triglyceride concentration | The concentration of triglyceride (in mmol/L) will be measured in blood during fasting and at 2 hours after consuming a standardized breakfast | Assessed at months 0 and 3 | |
Secondary | Fasting and postprandial C-reactive protein concentration | The concentration of CRP (in mg/L) will be measured in blood during fasting and at 2 hours after consuming a standardized breakfast | Assessed at months 0 and 3 | |
Secondary | Fasting and postprandial tumor necrosis factor alpha concentration | The concentration of TNFa (in ng/L) will be measured in blood during fasting and at 2 hours after consuming a standardized breakfast | Assessed at months 0 and 3 | |
Secondary | Fasting and postprandial ghrelin concentration | The concentration of ghrelin (in pg/mL) will be measured in blood during fasting and at 2 hours after consuming a standardized breakfast | Assessed at months 0 and 3 | |
Secondary | Fasting and postprandial leptin concentration | The concentration of leptin (in ng/mL) will be measured in blood during fasting and at 2 hours after consuming a standardized breakfast | Assessed at months 0 and 3 | |
Secondary | Fasting and postprandial glucagon like peptide 1 concentration | The concentration of GLP1 (in pg/mL) will be measured in blood during fasting and at 2 hours after consuming a standardized breakfast | Assessed at months 0 and 3 | |
Secondary | Fasting and postprandial peptide YY concentration | The concentration of PYY (in pg/mL) will be measured in blood during fasting and at 2 hours after consuming a standardized breakfast | Assessed at months 0 and 3 | |
Secondary | Fasting and postprandial cholecystokinin concentration | The concentration of CKK (in pg/mL) will be measured in blood during fasting and at 2 hours after consuming a standardized breakfast | Assessed at months 0 and 3 | |
Secondary | Fasting and postprandial interleukin 6 concentration | The concentration of IL6 (in ng/L) will be measured in blood during fasting and at 2 hours after consuming a standardized breakfast | Assessed at months 0 and 3 | |
Secondary | Cognitive functions: processing speed | Performance in neuropsychological assessment of processing speed as choice reaction time, CANTAB test battery. | Assessed at months 0, 3 and 9 | |
Secondary | Cognitive functions: Sustained attention | Performance in neuropsychological assessment of sustained attention ability assessed as errors during a sustained test procedure, CANTAB test battery. | Assessed at months 0, 3 and 9 | |
Secondary | 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). | Assessed at months 0, 3 and 9 | |
Secondary | 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) | Assessed at months 0, 3 and 9 | |
Secondary | 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) | Assessed at months 0, 3 and 9 | |
Secondary | School performance: mathematics performance | Mathematics proficiency will be measured by Hogrefe math test | Assessed at months 0, 3 and 9 | |
Secondary | School performance: reading comprehension | Danish reading proficiency will be measured by Hogrefe reading comprehension test | Assessed at months 0, 3 and 9 | |
Secondary | Neurophysiological Measurement 1 - ERP Amplitude | EEG activity measured as the event-related potential (ERP) amplitude during the modified Eriksen Flanker Test | Assessed at months 0 and 3 | |
Secondary | Neurophysiological Measurement 2 - Cortical activity during skill learning | Cortical activity during skill learning will be measured as EEG power | Assessed at months 0 and 3 | |
Secondary | Neurophysiological Measurement 3 - Muscle activity during skill learning | Muscle activity during skill learning will be measured as electromyography amplitude | Assessed at months 0 and 3 | |
Secondary | Neurophysiological Measurement 4 - corticocortical functional connectivity | Corticocortical functional connectivity will be measured as functional coupling in EEG (scale 0-1) | Assessed at months 0 and 3 | |
Secondary | Neurophysiological Measurement 5 - corticomuscular connectivity | Corticomuscular connectivity will be measured as functional coupling between EEG and EMG during skill learning (0-1) | Assessed at months 0 and 3 |
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