Effect of Sleep Extension on Overweight and Learning in Children

Child Development Clinical Trial

— More2Sleep  

Official title:

A Randomized Controlled Trial of Sleep Extension to Reduce Overweight and Improve Learning in Prepubescent Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06341179
• Other study ID #: M2S
• Secondary ID: H-23063352
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2024
• Source: University of Copenhagen
• Contact: Faidon Magkos, PhD
• Phone: +45 35 33 36 71
• Email: fma[@]nexs.ku.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Child Behavior
• Child Development
• Child Obesity
• Overweight
• Pediatric Obesity

Intervention

Behavioral:
• Sleep extension
Children and their parents will receive a behavioral intervention consisting of two in-person sessions and four virtual sessions. The two in-person sessions will take place at the beginning of the study (during weeks 1 and 2) and will focus on effective behavioral strategies to enhance sleep time, including goal setting (e.g., bedtimes and wake-up times), self-monitoring (via actigraphy), problem-solving and preplanning, stimulus control (i.e., sleep hygiene recommendations), and positive reinforcement. The four virtual sessions will take place at frequent intervals during the 12-week intervention (at weeks 4, 6, 8, and 10) and will act as reminders/refreshers to reinforce strategies to enhance changes in sleep time. Parents will receive advice in relation to altering only their children's sleeping routine (bedtime), and they will be instructed not to directly modify their children's food consumption or physical and sedentary activities during daytime.

Locations

Country	Name	City	State
Denmark	University of Copenhagen	Copenhagen
Denmark	University of Copenhagen	Copenhagen
Denmark	Faidon Magkos	Hvidovre

Sponsors (6)

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

Country where clinical trial is conducted

Denmark, 

Outcome

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