Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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28 August 2023 |
Main ID: |
ISRCTN17006300 |
Date of registration:
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28/07/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Sleep and lifestyle in school age children
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Scientific title:
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Sleep and lifestyle in school age children: a longitudinal study |
Date of first enrolment:
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15/08/2008 |
Target sample size:
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1500 |
Recruitment status: |
Completed |
URL:
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https://www.isrctn.com/ISRCTN17006300 |
Study type:
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Observational |
Study design:
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Longitudinal design (Screening)
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Phase:
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Not Applicable
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Pernilla
Garmy |
Address:
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Kristianstad University
29188
Kristianstad
Sweden |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Current version as of 21/03/2018: All students in grades 1, 4, 8 and 10 in seven municipalities in southern Sweden.
Previous version: All students at schools in the municipality of Lund in grades 1, 4, 8 and 10.
Exclusion criteria: Participants not meeting the inclusion criteria
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Sleep problems, obesity Signs and Symptoms
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Intervention(s)
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This is a longitudinal survey study where we are investigating sleep duration, BMI and media habits with questionnaires and height and weight measures. Each observation takes approximately 20 minutes (a visit at the school nurse) and this is repeated 4 times (in grades 1, 4, 8 and 10).
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Primary Outcome(s)
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1. Sleep and media habits among school-aged children and adolescents. Survey at four time-points: grades 1, 4, 8 and 10. Survey questionnaire concerns sleep and media habits 2. Body Mass Index among school-aged children and adolescents. Height and lengths are measured by trained school nurses at four time-points: grades 1, 4, 8 and 10 3. Physical activity, body image and self-rated health among adolescents. Survey at two time-points: grades 8 and 10. Survey questionnaire concerns frequency of exercise, self-reported fitness, body image and self-rated health
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Secondary Outcome(s)
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1. Validity and reliability test of the Minimal Insomnia Symptom Scale (MISS). Survey at two time-points: grades 8 and 10. Survey questionnaire consists of three questions concerning falling asleep, waking during the night and rested by sleep
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Source(s) of Monetary Support
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Högskolan Kristianstad, SSSH (Association for Lund University Nurses), Stiftelsen Kempe-Carlgrenska Fonden, Drottning Silvias barnsjukhus, The Fanny Ekdahl Foundation for Paediatric Research, Svenska Försäkringsföreningen, The Ebba Danelius Foundation (of the Swedish Society of Nursing), The Swedish Sleep Research Society
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Ethics review
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Status:
Approval date:
Contact:
Old ethics approval format; 1. Ethics Committee Lund University, 18/11/2009, ref: VEN 34-09
2. The Regional Ethical Review Board in Lund, 10/08/2011, ref: 2011/330
3. The Regional Ethical Review Board in Lund, 8/04/2015, ref: 2015/113
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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30/06/2020 |
URL:
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