Plain English Summary
Background and study aims
The aim of the study is to investigate how stress and/or physical activity influences children's psychological and physiological health at preschool level by focusing on four aspects: cognitive functioning, psychological well-being, adiposity (obesity) and motor skills.
Who can participate?
1150 children aged 2 to 6 of both genders
What does the study involve?
The child is tested at the start of the study and a year later. There are a number of tests, interviews and questionnaires.
What are the possible benefits and risks of participating?
The benefits of the study are three afternoons of different activities for the child. Previous research has shown that children enjoy the tests. There are no known negative side effects. The children get a little stuffed animal (called Splashy) and a T-shirt. Parents get a financial incentive for their efforts related to the study.
Where is the study run from?
The study has been set up by four research centers in three universities in Switzerland (Lausanne, Fribourg, Zurich).
When is study starting and how long is it expected to run for?
February 2014 to December 2016
Who is funding the study?
1. The Swiss National Science Foundation (Switzerland)
2. The Jacobs Foundation (Germany)
Who is the main contact?
Prof. Jardena Puder
Jardena.puder@chuv.ch
Trial website
Contact information
Type
Scientific
Primary contact
Prof Jardena Puder
ORCID ID
http://orcid.org/0000-0002-0460-7614
Contact details
University of Lausanne
Centere Hospitalier Universitaire Vaudoise
Ave de la Sallaz 8 - SA08/02/252
Lausanne
1011
Switzerland
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Relationship of stress and physical activity with psychological and physiological health in young children
Acronym
SPLASHY
Study hypothesis
The primary aim of the study is to investigate how stress and/or physical activity influences children's psychological and physiological health at preschool level by focusing on four aspects: cognitive functioning, psychological well being, adiposity and motor skills. It is assumed that:
1. Exposure to environmental stressors (major life events, chronic day-to day stressors), chronic physiological stress responses such as dysregulations of the hypothalamic-pituitary-adrenal (HPA) axis and the autonomic nervous system (ANS), and the acute stress reactivity (i.e., individual susceptibility) to a standardized stressor correlate with/predict increased adiposity, reduced cognitive functioning and reduced psychological health (i.e., including mood, behavioral problems and dysfunctional eating behavior scores).
2. High levels of total and moderate-to-vigorous physical activity correlate with/predict low adiposity, higher cognitive functioning and higher levels of motor skills and to fewer behavior problems and eating disorders.
The strength of association may vary with age. In addition, the moderating role of psychological children's (lifestyle, temperament, emotional well-being and self regulation) and environmental characteristics (family atmosphere, parental style, socioeconomic status, childcare center characteristics and large sociocultural environment such as German-French speaking parts of Switzerland) may influence the relationship of stress and physical activity on psychological and physiological health outcomes.
Ethics approval
Cantonal Ethics Committee, Canton de Vaud, Switzerland, 19/09/2013 (initial acceptance),14/01/2014 (amendment), ref: 338/2013
Study design
Multi-center prospective cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Patient information can be found at: http://splashy.ch/ or http://splashy.ch/fr/
Condition
Children, preschool
Intervention
If parents consent to participation in the study, their child is tested at two time periods including a baseline assessment and a follow-up (1 year later). A longer follow-up is planned. Baseline assessment includes three afternoons of tests of the children in the childcare setting including motor skills, medical, cognitive and adaptation tests and assessment of self regulation. During the 3 weeks of testing, children are asked to wear an ECG monitor during 24 hours (to measure heart rate variability, a measure of the ANS) and an accelerometer (to measure physical activity) during 1 week. Parents are asked to fill out two questionnaires (general health and lifestyle and psychological questionnaire including temperament, eating behavior, well-being, mood and parenting skills), participate in a telephone interview and to collect saliva for measures of cortisol (HPA) and alpha-amylase (measure of the ANS) of the child over 2 days, and to collect fingernails (HPA). Childcare educators are asked to fill out a questionnaire.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
The relationship of stress exposure, perception, behavior and physiological stress responses (using salivary cortisol and alpha-amylase daily profiles, cortisol in nails and heart rate variability) and physical activity (using an accelerometer) at baseline and at 1 year follow-up on children's health outcome at baseline and at 1-year follow-up including:
1. Psychological health, defined as
1.1. Mood (Strength and Difficulties questionnaire sdq [Goodman, 1997])
1.2. Behavioral problems (Strength and Difficulties questionnaire sdq [Goodman, 1997])
1.3. Eating behavior (Children's Eating Behaviour Questionnaire CEBQ [Wardle et al., 2001])
2. Physiological health, defined as
2.1. Cognitive functioning (Intelligence and Development Scales - Preschool IDS-P [Grob et al., 2009])
2.2. Physical activity (accelerometry)
2.3. Adiposity (BMI, waist circumference, skinfolds)
2.4. Motor skills by using the Zurich Neuromotor Assessement ZNA3-5 (Largo, Calfisch & Jenni, 2007)
Secondary outcome measures
1. Investigation of moderating factors, whenever applicable, including:
1.1. Psychological child factors at baseline and at 1-year follow-up: social behavior (Strength and Difficulties Questionnaire SDQ [Goodman, 1997]) and temperament (Emotionalitäts-Aktivitäts-Soziabilitäts-Temperamentinventar [Buss, A. & Plormin, R., 1994]); self-regulation capacity by using the statue test NEPSY ([Olsen et al. 1998] and/or delay of gratification [DOG], behavioral factors including lifestyle behavior [i.e. sleep and media use])
1.2. Environmental factors at baseline and at 1-year follow-up such as:
1.2.1. Family setting including socioeconomic status (SES, including migrant status, educational level and income), parenting style (Alabama Parenting Questionnaire APQ [Reichle & Franiek, 2009], parental stress (Parental Stress Scale [Berry, 1995]) and family atmosphere (Parental expressed emotions Five Minute Speech Sample FMSS; Magana, 1986; Leeb et al., 1991) and health attitudes of the parents
1.2.2. Childcare setting including childcare quality and health promotion
1.2.3. Sociocultural environment
1.3. Physiological health at baseline and at 1-year follow-up (physical activity by using accelerometer), adiposity (BMI, waist circumference and skinfold) and health problems (i.e. disease, symptoms)
2. Investigation of vulnerable time periods for effects of major life events or chronic stressors at baseline and at 1-year follow-up
Overall trial start date
01/02/2014
Overall trial end date
31/12/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current inclusion criteria as of May 2014 (trial record updated 16/03/2016):
2-6 year-old children of governmental and private childcare centers are randomly selected by stratifying socioeconomic status (SES) level. Each childcare center provides 12 children at maximum.
Previous inclusion criteria:
3-5 year-old children of governmental and private childcare centers are randomly selected by stratifying socioeconomic status (SES) level. Each childcare center provides 12 children at maximum.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
500 (1150 children contacted within n=96 child care centers)
Total final enrolment
463
Participant exclusion criteria
Unable to do the tests
Recruitment start date
01/03/2014
Recruitment end date
01/12/2015
Locations
Countries of recruitment
Switzerland
Trial participating centre
University of Lausanne
Lausanne
1010
Switzerland
Trial participating centre
University of Fribourg
Fribourg
1700
Switzerland
Trial participating centre
University of Zurich
Zurich
8001
Switzerland
Trial participating centre
Children’s Hospital Zurich – Eleonore Foundation
Zurich
8032
Switzerland
Sponsor information
Organisation
Swiss National Research Foundation (Switzerland)
Sponsor details
Wildhainweg 3
Postfach 8232
Bern
3012
Switzerland
-
sinergia@snf.ch
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung
Alternative name(s)
Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerischer Nationalfonds, SNF, SNSF, FNS
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
Switzerland
Funder name
Jacobs Foundation
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
Germany
Results and Publications
Publication and dissemination plan
Future publications in high-impact peer-reviewed journals are planned 2017 -2019
IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository [TEAMDRIVE 3]
Intention to publish date
31/12/2017
Participant level data
Stored in repository
Basic results (scientific)
Publication list
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27390933
2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/29618360
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31672126 (added 04/11/2019)