Sleep and lifestyle in school age children

ISRCTN	ISRCTN17006300
DOI	https://doi.org/10.1186/ISRCTN17006300
Secondary identifying numbers	N/A

Submission date: 09/07/2015
Registration date: 28/07/2015
Last edited: 18/08/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Mrs Pernilla Garmy
Scientific

Kristianstad University
Kristianstad
29188
Sweden

ORCID ID	0000-0003-1643-0171

Study information

Study design	Longitudinal design
Primary study design	Observational
Secondary study design	Longitudinal study
Study setting(s)	School
Study type	Screening
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Sleep and lifestyle in school age children: a longitudinal study
Study objectives	The study’s hypothesis is that sleep and media habits, body image, exercise habits, academic success and body mass index are interrelated.
Ethics approval(s)	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
Health condition(s) or problem(s) studied	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	Other
Primary outcome measure	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 study start date	01/03/2008
Completion date	30/06/2020

Eligibility

Participant type(s)	Mixed
Age group	Child
Sex	Both
Target number of participants	1500
Key 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.
Key exclusion criteria	Participants not meeting the inclusion criteria
Date of first enrolment	15/08/2008
Date of final enrolment	15/06/2019

Locations

Countries of recruitment

Sweden

Study participating centre

Kristianstad University

Kristianstad
29188
Sweden

Sponsor information

Kristianstad University
University/education

291 88 Kristianstad
Kristianstad
29188
Sweden

Phone	+4644208589
Email	pernilla.garmy@hkr.se
Website	www.hkr.se
"ROR"	https://ror.org/00tkrft03

Funders

Funder type

University/education

Högskolan Kristianstad
Government organisation / Local government

Alternative name(s): Kristianstad University, HKR
Location: Sweden

SSSH (Association for Lund University Nurses)

No information available

Stiftelsen Kempe-Carlgrenska Fonden
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): The Kempe-Carlgrenska Foundation
Location: Sweden

Drottning Silvias barnsjukhus
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): Queen Silvia Children’s Hospital, Drottning Silvias barn- och ungdomssjukhus
Location: Sweden

The Fanny Ekdahl Foundation for Paediatric Research

No information available

Svenska Försäkringsföreningen
Private sector organisation / Associations and societies (private and public)

Alternative name(s): Swedish Insurance Society, SFF
Location: Sweden

The Ebba Danelius Foundation (of the Swedish Society of Nursing)

No information available

The Swedish Sleep Research Society

No information available

Results and Publications

Intention to publish date	01/06/2017
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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.
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2012		Yes	No
Results article	results	01/12/2012		Yes	No
Results article	results	01/06/2014		Yes	No
Results article	results	01/03/2018		Yes	No
Results article		28/06/2022	18/08/2023	Yes	No
Results article		18/02/2020	18/08/2023	Yes	No
Results article		10/03/2022	18/08/2023	Yes	No
Results article		21/10/2021	18/08/2023	Yes	No
Results article		18/12/2019	18/08/2023	Yes	No

Editorial Notes

18/08/2023: Publication references added.
21/03/2018: Publication reference added. The participant inclusion criteria description has been changed.