Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06341179 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: More2Sleep
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment target: 300 to 142v4 Show 4 more changesShow less
    • Eligibility criteria expanded, about 70 words
    • Secondary endpoints: 38 to 26
    • Site contacts updated at 1 of 3 sites
    • Study title expanded, about 2 words
  2. Primary completion date: Dec 31, 2026 to Dec 31, 2027
    • Start date changed from estimate of May 15, 2024 to Aug 13, 2024
    • Study completion date: Dec 31, 2027 to Dec 31, 2028
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Apr 1, 2024 to May 15, 2024
    • Site details revised at 3 of 3 sites
    • Collaborators revised (5)
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06341179
Lead Sponsor University of Copenhagen
Collaborators: Novo Nordisk Foundation, Faculty of Health, Medicine and Life Sciences, Maastricht University, Center for Obesity Research & Education, Temple University, Danish Research Centre for Magnetic Resonance, University of Southern Denmark
Conditions
(from sponsor)		 Sleep Duration, Child Obesity, Child Development, Child Behavior
Related terms Behavior, Child Behavior, Obesity, Overweight, Pediatric Obesity, Sleep Initiation and Maintenance Disorders
Enrollment 142 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov