Plain English Summary
Background and study aims
Sleep problems in school-aged children have increased threefold during the last 30 years. The amount of sleep that children and adolescents have appears to have reduced by about an hour over the last 100 years. Meanwhile, the number of overweight and obese children is increasing, putting those affected at risk of cardiovascular and other diseases. Both short and overly long periods of sleep are associated with being overweight as an adult. It is important to investigate the activity habits that may affect sleep, for example access to bedroom TV, time spent on computer, television and other screens, as well as exercise. The overarching aim of this study is to longitudinally (that is, over a period of time) investigate sleep and media habits, body image, activity and body mass index in school-aged children and adolescents.
Who can participate?
All students in grades 1,4,8 at schools in the municipality of Lund.
What does the study involve?
Participants complete a survey questionnaire given during the regular visit to the school nurse. Height and weight are also measured at this time.
What are the possible benefits and risks of participating?
One benefit of the survey might be that it opens up a possibility for the student to discuss sleep and lifestyle factors with the school nurse. A risk is that, although the study is a voluntary one, the students will assume that they have to participate because the school nurse requests them to. The school nurses are therefore carefully informed that they have to highlight the voluntary nature of the study.
Where is the study run from?
Kristianstad University (Sweden)
When is the study starting and how long is it expected to run for?
March 2008 to June 2020
Who is funding the study?
Kristianstad University (Sweden)
Who is the main contact?
Mrs Pernilla Garmy
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Pernilla Garmy
ORCID ID
http://orcid.org/0000-0003-1643-0171
Contact details
Kristianstad University
Kristianstad
29188
Sweden
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Sleep and lifestyle in school age children: a longitudinal study
Acronym
Study hypothesis
The study’s hypothesis is that sleep and media habits, body image, exercise habits, academic success and body mass index are interrelated.
Ethics approval
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
Study design
Longitudinal design
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Schools
Trial type
Screening
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Sleep problems, obesity
Intervention
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).
Intervention type
Phase
Drug names
Primary outcome measures
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
Secondary outcome measures
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
Overall trial start date
01/03/2008
Overall trial end date
30/06/2020
Reason abandoned
Eligibility
Participant 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.
Participant type
Mixed
Age group
Child
Gender
Both
Target number of participants
1500
Participant exclusion criteria
Participants not meeting the inclusion criteria
Recruitment start date
15/08/2008
Recruitment end date
15/06/2019
Locations
Countries of recruitment
Sweden
Trial participating centre
Kristianstad University
Kristianstad
29188
Sweden
Sponsor information
Organisation
Kristianstad University
Sponsor details
291 88 Kristianstad
Kristianstad
29188
Sweden
+4644208589
pernilla.garmy@hkr.se
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Kristianstad University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
SSSH (Association for Lund University Nurses)
Alternative name(s)
Funding Body Type
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Location
Funder name
Kempe Carlgrenska Foundation
Alternative name(s)
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Location
Funder name
The Queen Silvia Jubilee Fund
Alternative name(s)
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Location
Funder name
The Fanny Ekdahl Foundation for Paediatric Research
Alternative name(s)
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Location
Funder name
The Swedish Insurance Society
Alternative name(s)
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Funder name
The Ebba Danelius Foundation (of the Swedish Society of Nursing)
Alternative name(s)
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Funder name
The Swedish Sleep Research Society
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
In 2017 and 2018 we plan to publish data from the 2015-2017 surveys, and in 2019 and 2020 we plan to publish data from the 2017-2019 surveys. The data will contain details about sleep habits, overweight, media habits, physical activity, as well as a psychometric test of the MISS questionnaire.
Intention to publish date
01/06/2017
Participant level data
Available on request
Results - basic reporting
Publication summary
1. 2012 results in https://www.ncbi.nlm.nih.gov/pubmed/22472633
2. 2012 results in https://www.ncbi.nlm.nih.gov/pubmed/21878574
3. 2013 results in https://www.ncbi.nlm.nih.gov/pubmed/23796145
4. 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29157744