Effect of Physical Activity an Stress in Children
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|ClinicalTrials.gov Identifier: NCT01693926|
Recruitment Status : Unknown
Verified May 2016 by Jardena Puder, University of Lausanne Hospitals.
Recruitment status was: Active, not recruiting
First Posted : September 26, 2012
Last Update Posted : May 12, 2016
The objective of the study is to evaluate the impact of physical activity in obese and nonobese prepubertal children on:
- biological stress responses during a psychosocial stress test
- snacking and feeling of hunger in response to the same psychosocial stress test
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Obesity Children Physical Activity Stress Snacking||Behavioral: Acute physical activity intervention Behavioral: placebo||Not Applicable|
Hypotheses In this study, 3 primary hypotheses will be tested.
- Moderate physical activity during 25 min in children decreases the cortisol levels in response to the Trier Social Stress Test TSST-C (for children).
- 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).
- 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).
- To test if the impact of physical activity on stress responses and snacking differs between obese and non-obese children
- 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?
- To test if the stress reactivity and its modulation by physical activity is different in anxious and in impulsives/labile children
- To test if serious life events and parental worries and parental educational style influence the stress reactivity
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Physical Activity an Stress in Children|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||December 2017|
Experimental: Acute physical activity intervention
25 min of moderate physical activity
Behavioral: Acute physical activity intervention
25 min of physical activity. The placebo arm will have 25 min of reading.
Placebo Comparator: Placebo
25 min of reading (instead of physical activity)
- Change in salivary Cortisol and maximal levels of salivary cortisol in response to the TSST stress test over 2 hours [ Time Frame: 9 months ]
- Snacking (Caloric intake, corrected for energy expenditure) [ Time Frame: 9 months ]Measure of caloric intake and measure of choice of high-caloric vs low-caloric food snacking after the TSST stress test
- 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 [ Time Frame: 9 months ]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).
- Moderator effect of obesity (WHO criteria) [ Time Frame: 9 months ]
- Cardiovascular reactivity (changes and maximal levels of blood pressure, heart rate) [ Time Frame: 9 months ]
- Perceived stress (stress scale from 1-7) [ Time Frame: 9 months ]
- Moderator role of serious life events and parental worries [ Time Frame: 9 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01693926
|Univeristy of Lausanne, SUPEA|
|Lausanne, VD, Switzerland, 1011|