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A Randomized Controlled Trial of Sleep Extension to Regulate Body Weight and Improve Learning in School-aged Children
Led by University of Copenhagen · Updated on 2025-11-25
142
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Copenhagen
Lead Sponsor
N
Novo Nordisk Foundation (NNF)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the effect of extending sleep by about 45 minutes each night on body weight and learning ability in school-aged children who have a body mass index (BMI) above average for their age and sex, and who usually sleep 9 hours or less per night. This randomized controlled trial includes 142 children aged 6 to 12 years. The study aims to understand how longer sleep impacts fat accumulation and learning skills in this group. Participants are divided into two groups: a sleep extension group and a control group. The sleep extension group will receive a behavioral intervention where parents help their children go to bed 60 to 90 minutes earlier, with six sessions offered both in-person and virtually over three months to support this change. The control group will keep their usual sleep schedule and attend the same number of meetings that focus on general well-being and information about sleep and diet recordings. Data will be collected at the start, after the three-month intervention, and again after six months of follow-up. Throughout the study, children will undergo various assessments including body measurements like BMI, body fat, and bone density, as well as tests of learning ability and cognitive function. The study will also monitor diet, physical activity, metabolic rates, and neurophysiological measures related to skill learning. These evaluations occur at multiple points during the study: months 0, 1.5, 3, and 9. Optional additional examinations will be offered to some participants based on availability. The total study duration for each child is nine months, combining intervention and follow-up.
CONDITIONS
Brief Title
Effect of Sleep Extension on Body Weight and Learning in Children (More2Sleep)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 6 and 12 years old (inclusive)
- BMI above average for age and sex, based on WHO reference standards
- Habitual sleep duration of 9 hours or less per night, reported by parents
You will not qualify if you...
- Any genetic, neurological, endocrinological, or psychiatric condition affecting growth, metabolism, eating behaviors, cognitive function, or body weight
- Any diagnosed sleep-related disorder such as obstructive sleep apnea, parasomnias, narcolepsy, or restless leg syndrome
- Regular use of medications that influence study outcomes
- Irregular school schedule
- If parents live separately and one does not wish to follow the sleep intervention, child should only sleep at that parent's home on Friday, Saturday, and/or Sunday nights
- Child or parents do not speak or understand Danish, unless both speak and understand English
- Participation in other research studies
- Presence of metal implants or claustrophobia (only for participants in substudy-II)
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual)
Duration - 12 weeks
Participants in the sleep extension group receive a behavioral intervention to increase sleep duration by 60-90 minutes via 6 sessions including both in-person and virtual meetings. The first two sessions occur at the beginning of the study focusing on sleep strategies, with subsequent sessions scheduled regularly during the 12-week intervention. The control group follows their habitual sleep schedule with educational sessions matching the treatment group’s session frequency.
6 sessions (combination of in-person and virtual)
Duration - Up to 9 months from the start of treatment
Participants continue to be assessed for body weight, learning ability, cognitive functions, and other health measures up to 9 months after starting the study.
Assessments at months 3 and 9
Trial Site Locations
Total: 3 locations
1
University of Copenhagen
Copenhagen, Denmark, 1958
Actively Recruiting
2
University of Copenhagen
Copenhagen, Denmark, 2200
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3
Faidon Magkos
Hvidovre, Denmark, 2650
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Research Team
F
Faidon Magkos, PhD
E
Eva Leedo-Townend, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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