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CompletedNCT01693926Updated Mar 25, 2020

Effect of Physical Activity an Stress in Children

An interventional study of Acute physical activity intervention and placebo in Obesity, Children and Physical Activity, sponsored by University of Lausanne Hospitals. Completed at 1 site in Switzerland. Open to participants aged 7 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-25.

Sponsored by University of Lausanne Hospitals · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
7 Years to 10 Years
Sex
All
01

Study summary

The objective of the study is to evaluate the impact of physical activity in obese and nonobese prepubertal children on:

  1. biological stress responses during a psychosocial stress test
  2. snacking and feeling of hunger in response to the same psychosocial stress test
  3. the moderating factor of attachment on the biological stress responses and on snacking

Children will be investigated on one study day during 3.5 hours.

Read the detailed description

Hypotheses In this study, 3 primary hypotheses will be tested.

  1. Moderate physical activity during 25 min in children decreases the cortisol levels in response to the Trier Social Stress Test TSST-C (for children).
  2. Moderate physical activity during 25 min in children decreases the snacking (calorie consumption when corrected for expenditure and switch in quality of food intake) in response to the Trier Social Stress Test TSST-C (for children).
  3. A secure attachment will be a moderating factor for the general increase in cortisol and the snacking in response to the psychosocial stress test (Trier Social Stress Test TSST-C).

Secondary objectives:

  1. To test if the impact of physical activity on stress responses and snacking differs between obese and non-obese children
  2. To test the impact of physical activity on the cardiovascular stress reactivity (blood pressure, heart rate) and the perceived stress (scale) in response to the Trier Social Stress Test TSST-C?
  3. To test if the stress reactivity and its modulation by physical activity is different in anxious and in impulsives/labile children
  4. To test if serious life events and parental worries and parental educational style influence the stress reactivity
02

Conditions studied

  • Obesity
  • Children
  • Physical Activity
  • Stress
  • Snacking

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Keywords

  • Obesity
  • Children
  • Physical activity
  • Stress
  • Snacking
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 50 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of Lausanne Hospitals is the lead sponsor of 118 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 7-10 year old children

Exclusion criteria

Exclusion Criteria:

  • Severe illness
  • Medications interfering with study
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Acute physical activity intervention

    25 min of moderate physical activity

    Behavioral: Acute physical activity intervention

  • Placebo comparator
    Placebo

    25 min of reading (instead of physical activity)

    Behavioral: placebo

Interventions

  • BehavioralAcute physical activity intervention

    25 min of physical activity. The placebo arm will have 25 min of reading.

  • Behavioralplacebo
06

What researchers measure

Primary outcomes

  1. Change in salivary Cortisol and maximal levels of salivary cortisol in response to the TSST stress test over 2 hours

    Time frame: 9 months

  2. Snacking (Caloric intake, corrected for energy expenditure)

    Measure of caloric intake and measure of choice of high-caloric vs low-caloric food snacking after the TSST stress test

    Time frame: 9 months

  3. Moderator effect of attachment (4 different attachment categories), i.e. children with a secure attachment will have lower rises in cortisol compared with children in the other 3 attachment categories

    Cortisol levels after the TSST stress test will be lower in children with secure attachment compared to detached, disorganized or preoccupied children (i.e. the 3 other attachment categories).

    Time frame: 9 months

Secondary outcomes

  1. Moderator effect of obesity (WHO criteria)

    Time frame: 9 months

  2. Cardiovascular reactivity (changes and maximal levels of blood pressure, heart rate)

    Time frame: 9 months

  3. Perceived stress (stress scale from 1-7)

    Time frame: 9 months

  4. Moderator role of serious life events and parental worries

    Time frame: 9 months

07

Study locations

1 site
  • Univeristy of Lausanne, SUPEA
    Lausanne, VD 1011, Switzerland
08

References and documents

Publications

  • Horsch A, Wobmann M, Kriemler S, Munsch S, Borloz S, Balz A, Marques-Vidal P, Borghini A, Puder JJ. Impact of physical activity on energy balance, food intake and choice in normal weight and obese children in the setting of acute social stress: a randomized controlled trial. BMC Pediatr. 2015 Feb 19;15:12. doi: 10.1186/s12887-015-0326-7. PubMed 25879821 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01693926
Lead sponsor
University of Lausanne Hospitals
Responsible party
Jardena Puder (Medin adjoint, University of Lausanne Hospitals) — Principal investigator
First posted
Sep 26, 2012
Start date
Sep 2012
Primary completion
Jun 2013
Completion
Dec 2017
Last update
Mar 25, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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