Effect of Physical Activity an Stress in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University of Lausanne Hospitals
Sponsor:
Information provided by (Responsible Party):
Jardena Puder, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT01693926
First received: August 29, 2012
Last updated: April 18, 2013
Last verified: April 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]
  • Snacking (Caloric intake, corrected for energy expenditure) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Cardiovascular reactivity (changes and maximal levels of blood pressure, heart rate) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Perceived stress (stress scale from 1-7) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Moderator role of serious life events and parental worries [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Study Completion Date: December 2013
Estimated 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

Ages Eligible for Study:   7 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 7-10 year old children

Exclusion Criteria:

  • Severe illness
  • Medications interfering with study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693926

Locations
Switzerland
Univeristy of Lausanne, SUPEA Recruiting
Lausanne, VD, Switzerland, 1011
Contact: Jardena J Puder, MD    +41-21-314 06 38    jardena.puder@chuv.ch   
Principal Investigator: Jardena J Puder, MD         
Sponsors and Collaborators
University of Lausanne Hospitals
  More Information

No publications provided

Responsible Party: Jardena Puder, Medin adjoint, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT01693926     History of Changes
Other Study ID Numbers: 286/12
Study First Received: August 29, 2012
Last Updated: April 18, 2013
Health Authority: Switzerland: Cantonal ethical committee of Vaud

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

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014