Effect of Sleep Extension on Overweight and Learning in Children
- Conditions
- Sleep DurationChild ObesityChild DevelopmentChild Behavior
- Interventions
- Behavioral: Sleep extension
- Registration Number
- NCT06341179
- Lead Sponsor
- University of Copenhagen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sleep extension Sleep extension The sleep extension group (n=150) will receive a behavioral intervention focusing on parents putting their children to bed earlier by 60-90 minutes. Parents will be instructed only to alter their children's daily sleeping routine, and not to directly alter their diet and physical activity habits. The intervention will be delivered via 2 in-person (weeks 1 and 2) and 4 virtual meetings (weeks 4, 6, 8, and 10).
- Primary Outcome Measures
Name Time Method BMI Z-score Assessed 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: Explicit memory Assessed 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)
Learning ability: skill learning Assessed 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)
- Secondary Outcome Measures
Name Time Method Neurophysiological Measurement 2 - Cortical activity during skill learning Assessed at months 0 and 3 Cortical activity during skill learning will be measured as EEG power
Bone mineral content (BMC) Assessed at months 0, 3 and 9 BMC (in grams) will be measured by a whole-body dual-energy X-ray absorptiometry (DXA) scan
Dietary protein, carbohydrate, fiber, and fat intakes Assessed at months 0, 3 and 9 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)
Total energy expenditure (TEE) Assessed at months 0 and 3 TEE (in kcal/day) will be measured by using the doubly labelled water method (8 urine samples over 2 weeks)
Fasting and postprandial glucose concentration Assessed at months 0 and 3 The concentration of glucose (in mmol/L) will be measured in blood during fasting and at 2 hours after consuming a standardized breakfast
Total lean mass (LM) Assessed at months 0, 3 and 9 Body LM (in grams) will be measured by a whole-body dual-energy X-ray absorptiometry (DXA) scan
Dietary energy intake Assessed at months 0, 3 and 9 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)
Fasting and postprandial insulin concentration Assessed at months 0 and 3 The concentration of insulin (in pmol/L) will be measured in blood during fasting and at 2 hours after consuming a standardized breakfast
Fasting and postprandial interleukin 6 concentration Assessed at months 0 and 3 The concentration of IL6 (in ng/L) will be measured in blood during fasting and at 2 hours after consuming a standardized breakfast
Neurophysiological Measurement 4 - corticocortical functional connectivity Assessed at months 0 and 3 Corticocortical functional connectivity will be measured as functional coupling in EEG (scale 0-1)
Body fat percent Assessed at months 0, 3 and 9 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
Bone mineral density (BMD) Assessed at months 0, 3 and 9 Areal BMD (in grams/cm\^2) will be measured by a whole-body dual-energy X-ray absorptiometry (DXA) scan
Total fat mass (FM) Assessed at months 0, 3 and 9 Body FM (in grams) will be measured by a whole-body dual-energy X-ray absorptiometry (DXA) scan
Resting metabolic rate (RMR) Assessed at months 0 and 3 RMR (in kcal/day) will be measured with indirect calorimetry (canopy mode) the morning after an overnight fast (at least 8 hours)
Fasting and postprandial ghrelin concentration Assessed at months 0 and 3 The concentration of ghrelin (in pg/mL) will be measured in blood during fasting and at 2 hours after consuming a standardized breakfast
Subjective hunger Assessed at months 0 and 3 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)
Weight Assessed at months 0, 3 and 9 Body mass (in kg) will be measured on a digital scale to the nearest 0.1 kg
Fasting and postprandial peptide YY concentration Assessed at months 0 and 3 The concentration of PYY (in pg/mL) will be measured in blood during fasting and at 2 hours after consuming a standardized breakfast
Cognitive functions: Inhibitory control Assessed at months 0, 3 and 9 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)
Cognitive functions: Cognitive flexibility Assessed at months 0, 3 and 9 Performance in neuropsychological assessment of cognitive flexibility assessed as errors during the test procedure (Cambridge Neuropsychological Test Automated Battery, Cambridge cognition, UK)
Neurophysiological Measurement 5 - corticomuscular connectivity Assessed at months 0 and 3 Corticomuscular connectivity will be measured as functional coupling between EEG and EMG during skill learning (0-1)
Physical activity (PA) time: total PA and MVPA Assessed at months 0, 1.5,3 and 9 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
Thermic effect of food (TEF) Assessed at months 0 and 3 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
Height Assessed at months 0, 3 and 9 Stature (in cm) will be measured using a wall-mounted stadiometer to the nearest 0.1 cm
Fasting and postprandial triglyceride concentration Assessed at months 0 and 3 The concentration of triglyceride (in mmol/L) will be measured in blood during fasting and at 2 hours after consuming a standardized breakfast
Cognitive functions: Spatial working memory Assessed at months 0, 3 and 9 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).
School performance: reading comprehension Assessed at months 0, 3 and 9 Danish reading proficiency will be measured by Hogrefe reading comprehension test
Neurophysiological Measurement 3 - Muscle activity during skill learning Assessed at months 0 and 3 Muscle activity during skill learning will be measured as electromyography amplitude
Fasting and postprandial total, HDL and LDL cholesterol concentrations Assessed at months 0 and 3 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
Fasting and postprandial C-reactive protein concentration Assessed at months 0 and 3 The concentration of CRP (in mg/L) will be measured in blood during fasting and at 2 hours after consuming a standardized breakfast
Fasting and postprandial tumor necrosis factor alpha concentration Assessed at months 0 and 3 The concentration of TNFa (in ng/L) will be measured in blood during fasting and at 2 hours after consuming a standardized breakfast
Fasting and postprandial leptin concentration Assessed at months 0 and 3 The concentration of leptin (in ng/mL) will be measured in blood during fasting and at 2 hours after consuming a standardized breakfast
Fasting and postprandial glucagon like peptide 1 concentration Assessed at months 0 and 3 The concentration of GLP1 (in pg/mL) will be measured in blood during fasting and at 2 hours after consuming a standardized breakfast
Fasting and postprandial cholecystokinin concentration Assessed at months 0 and 3 The concentration of CKK (in pg/mL) will be measured in blood during fasting and at 2 hours after consuming a standardized breakfast
Cognitive functions: processing speed Assessed at months 0, 3 and 9 Performance in neuropsychological assessment of processing speed as choice reaction time, CANTAB test battery.
Cognitive functions: Sustained attention Assessed at months 0, 3 and 9 Performance in neuropsychological assessment of sustained attention ability assessed as errors during a sustained test procedure, CANTAB test battery.
School performance: mathematics performance Assessed at months 0, 3 and 9 Mathematics proficiency will be measured by Hogrefe math test
Neurophysiological Measurement 1 - ERP Amplitude Assessed at months 0 and 3 EEG activity measured as the event-related potential (ERP) amplitude during the modified Eriksen Flanker Test
Trial Locations
- Locations (2)
University of Copenhagen
🇩🇰Copenhagen, Denmark
Faidon Magkos
🇩🇰Hvidovre, Denmark