Condition category
Signs and Symptoms
Date applied
09/07/2015
Date assigned
28/07/2015
Last edited
27/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 grade 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

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

www.hkr.se

Funders

Funder type

University/education

Funder name

Kristianstad University

Alternative name(s)

Funding Body Type

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Location

Funder name

SSSH (Association for Lund University Nurses)

Alternative name(s)

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Funder name

Kempe Carlgrenska Foundation

Alternative name(s)

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Funder name

The Queen Silvia Jubilee Fund

Alternative name(s)

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Funder name

The Fanny Ekdahl Foundation for Paediatric Research

Alternative name(s)

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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)

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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

2013 Garmy P, Clausson, EK, Nyberg P, Jakobsson U. (2014), Overweight and television and computer habits in Swedish school-age children and adolescents: A cross-sectional study. Nursing & Health Sciences, 16: 143–148. doi: 10.1111/nhs.12076

2012 Garmy P, Nyberg P, Jakobsson U. (2012) Sleep and television and computer habits of Swedish school-age children. Journal of School Nursing. 28(6): 469-76.

2012 Garmy P, Jakobsson U, Nyberg P. (2012) Development and psychometric evaluation of a new instrument for measuring sleep length and television and computer habits in school-age children. Journal of School Nursing. 28:138-43.

Publication citations

Additional files

Editorial Notes