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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 9
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Denmark
University of Copenhagen
RECRUITING
Copenhagen
University of Copenhagen
RECRUITING
Copenhagen
Faidon Magkos
RECRUITING
Hvidovre
Contact Information
Primary
Faidon Magkos, PhD
fma@nexs.ku.dk
+45 35 33 36 71
Backup
Cecilie H. Rasmussen, MSc
chr@nexs.ku.dk
+45 35 33 58 27
Time Frame
Start Date: 2024-08-13
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 300
Treatments
Experimental: 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).
No_intervention: Control
The control group (n=150) will follow their habitual sleeping schedule. Parents will be instructed not to alter their children's daily sleeping routine, or their diet and physical activity habits. The same number and frequency of meetings (in-person or virtual) and methods of registration of bedtime/wake-up times will be used as in the sleep extension group. All sessions for the control group will be educational in nature and will focus on the appropriate use of devices to monitor sleep, and preparation for the assessments.
Related Therapeutic Areas
Sponsors
Collaborators: Center for Obesity Research & Education, Temple University, University of Southern Denmark, Novo Nordisk Foundation (NNF), Faculty of Health, Medicine and Life Sciences, Maastricht University, Danish Research Centre for Magnetic Resonance
Leads: University of Copenhagen

This content was sourced from clinicaltrials.gov