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Effect of Physical Activity an Stress in Children

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01693926
First Posted: September 26, 2012
Last Update Posted: May 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jardena Puder, University of Lausanne Hospitals
  Purpose

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.


Condition Intervention
Obesity Children Physical Activity Stress Snacking Behavioral: Acute physical activity intervention Behavioral: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Physical Activity an Stress in Children

Resource links provided by NLM:


Further study details as provided by Jardena Puder, University of Lausanne Hospitals:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Study Completion Date: December 2017
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Behavioral: placebo

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 7-10 year old children

Exclusion Criteria:

  • Severe illness
  • Medications interfering with study
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Switzerland
Univeristy of Lausanne, SUPEA
Lausanne, VD, Switzerland, 1011
Sponsors and Collaborators
University of Lausanne Hospitals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jardena Puder, Medin adjoint, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT01693926     History of Changes
Other Study ID Numbers: 286/12
First Submitted: August 29, 2012
First Posted: September 26, 2012
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by Jardena Puder, University of Lausanne Hospitals:
Obesity
Children
Physical activity
Stress
Snacking