Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

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 will be invited to participate.

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?
The study starts in February 2014 and will continue to recruit participants until November 2015.

Who is funding the study?
The Swiss National Research Foundation

Who is the main contact?
Dr Jardena Puder

Trial website

Contact information



Primary contact

Dr Jardena Puder


Contact details

University of Lausanne
Centre Hospitalier Universitaire Vaudoise
Rue du Bugnon 46
BH 19-709

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Relationship of stress and physical activity with psychological and physiological health in young children



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.

We further assume that 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


Secondary study design

Cohort study

Trial setting


Trial type

Quality of life

Patient information sheet

Patient information can be found at: or


Children, preschool


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



Not Applicable

Drug names

Primary outcome measures

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


Overall trial end date


Reason abandoned


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


Age group




Target number of participants

500 (1150 children contacted within n=96 child care centers)

Participant exclusion criteria

Unable to do the tests

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

University of Lausanne

Sponsor information


Swiss National Research Foundation (Switzerland)

Sponsor details

Wildhainweg 3
Postfach 8232

Sponsor type

Research organisation



Funder type

Research organisation

Funder name

Swiss National Research Foundation (CRSII3_141908) (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 protocol in:

Publication citations

Additional files

Editorial Notes

11/07/2016: Publication reference added.