protocolSection identificationModule nctId: NCT06341179, orgStudyIdInfo id: M2S, secondaryIdInfos id: H-23063352, type: OTHER, domain: Vek.dk, briefTitle: Effect of Sleep Extension on Overweight and Learning in Children, acronym: More2Sleep, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: University of Copenhagen, class: OTHER, collaborators name: Novo Nordisk A/S, collaborators name: Faculty of Health, Medicine and Life Sciences, Maastricht University, collaborators name: Center for Obesity Research & Education, Temple University, collaborators name: Danish Research Centre for Magnetic Resonance, collaborators name: University of Southern Denmark, descriptionModule briefSummary: 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., conditionsModule conditions: Sleep Duration, conditions: Child Obesity, conditions: Child Development, conditions: Child Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Sleep extension, outcomesModule primaryOutcomes measure: BMI Z-score, primaryOutcomes measure: Learning ability: skill learning, primaryOutcomes measure: Learning ability: Explicit memory, secondaryOutcomes measure: Body fat percent, secondaryOutcomes measure: Total fat mass (FM), secondaryOutcomes measure: Total lean mass (LM), secondaryOutcomes measure: Bone mineral content (BMC), secondaryOutcomes measure: Bone mineral density (BMD), secondaryOutcomes measure: Dietary energy intake, secondaryOutcomes measure: Dietary protein, carbohydrate, fiber, and fat intakes, secondaryOutcomes measure: Subjective hunger, secondaryOutcomes measure: Physical activity (PA) time: total PA and MVPA, secondaryOutcomes measure: Resting metabolic rate (RMR), secondaryOutcomes measure: Thermic effect of food (TEF), secondaryOutcomes measure: Weight, secondaryOutcomes measure: Height, secondaryOutcomes measure: Total energy expenditure (TEE), secondaryOutcomes measure: Fasting and postprandial glucose concentration, secondaryOutcomes measure: Fasting and postprandial insulin concentration, secondaryOutcomes measure: Fasting and postprandial total, HDL and LDL cholesterol concentrations, secondaryOutcomes measure: Fasting and postprandial triglyceride concentration, secondaryOutcomes measure: Fasting and postprandial C-reactive protein concentration, secondaryOutcomes measure: Fasting and postprandial tumor necrosis factor alpha concentration, secondaryOutcomes measure: Fasting and postprandial ghrelin concentration, secondaryOutcomes measure: Fasting and postprandial leptin concentration, secondaryOutcomes measure: Fasting and postprandial glucagon like peptide 1 concentration, secondaryOutcomes measure: Fasting and postprandial peptide YY concentration, secondaryOutcomes measure: Fasting and postprandial cholecystokinin concentration, secondaryOutcomes measure: Fasting and postprandial interleukin 6 concentration, secondaryOutcomes measure: Cognitive functions: processing speed, secondaryOutcomes measure: Cognitive functions: Sustained attention, secondaryOutcomes measure: Cognitive functions: Spatial working memory, secondaryOutcomes measure: Cognitive functions: Inhibitory control, secondaryOutcomes measure: Cognitive functions: Cognitive flexibility, secondaryOutcomes measure: School performance: mathematics performance, secondaryOutcomes measure: School performance: reading comprehension, secondaryOutcomes measure: Neurophysiological Measurement 1 - ERP Amplitude, secondaryOutcomes measure: Neurophysiological Measurement 2 - Cortical activity during skill learning, secondaryOutcomes measure: Neurophysiological Measurement 3 - Muscle activity during skill learning, secondaryOutcomes measure: Neurophysiological Measurement 4 - corticocortical functional connectivity, secondaryOutcomes measure: Neurophysiological Measurement 5 - corticomuscular connectivity, otherOutcomes measure: Health-related quality of life: child-reported, otherOutcomes measure: Health-related quality of life: parent-reported, otherOutcomes measure: Mental health: parent-reported, otherOutcomes measure: Parental Stress Scale: parent-reported, otherOutcomes measure: Perceived Stress Scale: child-reported, otherOutcomes measure: Demographics: income, otherOutcomes measure: Demographics: education, otherOutcomes measure: Wakefulness, otherOutcomes measure: Handedness, otherOutcomes measure: Fine Motor Control, otherOutcomes measure: Muscle strength, otherOutcomes measure: Brain myelination, otherOutcomes measure: Brain structural connectivity and microstructure, otherOutcomes measure: Brain functional connectivity, otherOutcomes measure: Vital signs: blood pressure, otherOutcomes measure: Vital signs: heart rate, otherOutcomes measure: Vital signs: temperature, otherOutcomes measure: Sleep quality: self-reported sleep duration, otherOutcomes measure: Sleep quality: self-reported latency, otherOutcomes measure: Sleep quality: self-reported awakenings, otherOutcomes measure: Sleep quality: self-reported tiredness/sleepiness, otherOutcomes measure: Sleep quality and architecture: Sleep stages, otherOutcomes measure: Sleep quality and architecture: sleep duration, otherOutcomes measure: Sleep quality and architecture: sleep latency, otherOutcomes measure: Sleep quality and architecture: awakenings, otherOutcomes measure: Sleep quality and architecture: arousals, otherOutcomes measure: Sleep: duration, otherOutcomes measure: Sleep: movements, otherOutcomes measure: Sleep: awakenings, otherOutcomes measure: Brain structure: cortical thickness, otherOutcomes measure: Brain structure: volume, otherOutcomes measure: Brain structure: Surface, otherOutcomes measure: Brain structure: volumes of subcortical grey matter structures, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 9 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of Copenhagen, city: Copenhagen, zip: 1958, country: Denmark, contacts name: Faidon Magkos, PhD, role: CONTACT, phone: +45 35 33 36 71, email: fma@nexs.ku.dk, contacts name: Cecilie Rasmussen, MSc, role: CONTACT, phone: +45 35 33 58 27, email: chr@nexs.ku.dk, contacts name: Faidon Magkos, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jesper Lundbye-Jensen, PhD, role: SUB_INVESTIGATOR, contacts name: Poul Jennum, MD, role: SUB_INVESTIGATOR, geoPoint lat: 55.67594, lon: 12.56553, locations facility: University of Copenhagen, city: Copenhagen, zip: 2200, country: Denmark, contacts name: Faidon Magkos, PhD, role: CONTACT, phone: +45 35 33 36 71, email: fma@nexs.ku.dk, contacts name: Jesper Lundbye-Jensen, PhD, role: CONTACT, phone: +45 35 32 73 30, email: jlundbye@nexs.ku.dk, contacts name: Faidon Magkos, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jesper Lundbye-Jensen, PhD, role: SUB_INVESTIGATOR, contacts name: Poul Jennum, MD, role: SUB_INVESTIGATOR, geoPoint lat: 55.67594, lon: 12.56553, locations facility: Faidon Magkos, city: Hvidovre, zip: 2650, country: Denmark, contacts name: Faidon Magkos, PhD, role: CONTACT, phone: +45 35 33 36 71, email: fma@nexs.ku.dk, contacts name: Faidon Magkos, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jesper Lundbye-Jensen, PhD, role: SUB_INVESTIGATOR, contacts name: Kathrine Madsen, PhD, role: SUB_INVESTIGATOR, contacts name: Hartwig Siebner, MD, role: SUB_INVESTIGATOR, contacts name: Poul Jennum, MD, role: SUB_INVESTIGATOR, geoPoint lat: 55.65719, lon: 12.47364, hasResults: False