Effect of Sleep Extension on Body Weight and Learning in Children (More2Sleep)

Официальное название

A Randomized Controlled Trial of Sleep Extension to Regulate Body Weight and Improve Learning in School-aged Children

Обзор

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.

Вмешательства

• Поведенческое Sleep extension
  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,

Первичные конечные точки

• BMI Z-score [Срок оценки: Assessed at months 0, 3 and 9]
• Learning ability: skill learning [Срок оценки: Assessed at months 0 and 3]
• Learning ability: Explicit memory [Срок оценки: Assessed at months 0 and 3]

Вторичные конечные точки (12)

• Body fat percent [Срок оценки: Assessed at months 0, 3 and 9]
• Total fat mass (FM) [Срок оценки: Assessed at months 0, 3 and 9]
• Total lean mass (LM) [Срок оценки: Assessed at months 0, 3 and 9]
• Bone mineral content (BMC) [Срок оценки: Assessed at months 0, 3 and 9]
• Bone mineral density (BMD) [Срок оценки: Assessed at months 0, 3 and 9]
• Dietary energy intake [Срок оценки: Assessed at months 0, 3 and 9]
• Dietary protein, carbohydrate, fiber, and fat intakes [Срок оценки: Assessed at months 0, 3 and 9]
• Subjective hunger [Срок оценки: Assessed at months 0 and 3]
• Physical activity (PA) time: total PA and MVPA [Срок оценки: Assessed at months 0, 1.5,3 and 9]
• Resting metabolic rate (RMR) [Срок оценки: Assessed at months 0 and 3]
• Thermic effect of food (TEF) [Срок оценки: Assessed at months 0 and 3]
• Weight [Срок оценки: Assessed at months 0, 3 and 9]

Критерии участия

Критерии включения

• Age: 6-12 years old (inclusive range).
• Weight status: having a BMI above average, defined as an age- and sex-specific BMI Z-score above zero using reference standards from the WHO.
• 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.

Критерии исключения

• Any genetic, neurological, endocrinological or psychiatric condition that affects growth, metabolism, eating behaviors, cognitive function, or body weight (for example: dwarfism, epilepsy, attention deficit hyperactivity disorder, head trauma, β-thalassemia, hypothyroid-ism, hyperthyroidism, 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 outcomes.
• Irregular school schedule.
• If a child's parents live separately, the child is allowed to sleep at both households. How-ever, if one of the parents does not wish to carry out the sleep intervention and follow given instructions, then the child should only sleep at their household Friday, Saturday and/or Sunday night.
• In the circumstance where the child does not speak or understand Danish, the child's parents do not have to speak or understand Danish, as long as both parties can speak and understand English.
• Participation in other research studies.
• Metal implants and claustrophobia (only for substudy-II).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Дания · 3 центра

• University of Copenhagen — Copenhagen
• University of Copenhagen — Copenhagen
• Faidon Magkos — Hvidovre

Публикации

• Rasmussen CH, Neesgaard ND, Skriver-Bayer M, Muushardt CS, Leedo-Townend E, Bjorndal JR, Rosenkrans MI, Wulff-Abramsson A, Mejer L, Madsen KS, Johnsen LK, Siebner HR, Debes NM, Hart CN, Plasqui G, Grontved A, Nielsen G, Jennum PJ, Lundbye-Jensen J, Magkos F. Protocol for a randomized controlled trial investigating the effects of sleep extension on body weight and learning in children (More2Sleep). PMID 42199500

Идентификаторы

NCT: NCT06341179 · M2S · H-23063352

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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