The Swiss Preschool Health Study (SPLASHY)

ISRCTN	ISRCTN41045021
DOI	https://doi.org/10.1186/ISRCTN41045021
Protocol serial number	N/A
Sponsor	Swiss National Research Foundation (Switzerland)
Funders	Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung, Jacobs Foundation

Submission date: 21/03/2014
Registration date: 06/05/2014
Last edited: 25/11/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Jardena Puder
Scientific

University of Lausanne
Centere Hospitalier Universitaire Vaudoise
Ave de la Sallaz 8 - SA08/02/252
Lausanne
1011
Switzerland

ORCID ID	0000-0002-0460-7614

Study information

Primary study design	Observational
Study design	Multi-center prospective cohort study
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	Relationship of stress and physical activity with psychological and physiological health in young children
Study acronym	SPLASHY
Study objectives	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(s)	Cantonal Ethics Committee, Canton de Vaud, Switzerland, 19/09/2013 (initial acceptance),14/01/2014 (amendment), ref: 338/2013
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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
Completion date	31/12/2016

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	2 Years
Upper age limit	6 Years
Sex	All
Target sample size at registration	500
Total final enrolment	463
Key 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.
Key exclusion criteria	Unable to do the tests
Date of first enrolment	01/03/2014
Date of final enrolment	01/12/2015

Locations

Countries of recruitment

Switzerland

Study participating centres

University of Lausanne

Lausanne
1010
Switzerland

University of Fribourg

Fribourg
1700
Switzerland

University of Zurich

Zurich
8001
Switzerland

Children’s Hospital Zurich – Eleonore Foundation

Zurich
8032
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan	The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository [TEAMDRIVE 3]

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	04/04/2018		Yes	No
Results article	results	31/10/2019	04/11/2019	Yes	No
Results article	secondary outcomes on parenting styles	22/11/2022	25/11/2022	Yes	No
Protocol article	protocol	08/07/2016		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

25/11/2022: Publication reference added.
04/11/2019: The following changes were made:
1. Publication reference added.
2. The final enrolment number was added from the reference.
18/12/2018: Publication reference added.
02/06/2017: The recruitment dates were changed from 01/02/2014 - 01/11/2015 to 01/03/2014 - 01/12/2015.
22/05/2017: Jacobs Foundation was added to the list of funders.
11/07/2016: Publication reference added.