- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01693926
Effect of Physical Activity an Stress in Children
March 23, 2020 updated by: Jardena Puder, University of Lausanne Hospitals
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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).
Secondary objectives:
- 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
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
VD
-
Lausanne, VD, Switzerland, 1011
- Univeristy of Lausanne, SUPEA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 7-10 year old children
Exclusion Criteria:
- Severe illness
- Medications interfering with study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Acute physical activity intervention
25 min of moderate physical activity
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in salivary Cortisol and maximal levels of salivary cortisol in response to the TSST stress test over 2 hours
Time Frame: 9 months
|
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
|
9 months
|
|
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).
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Moderator effect of obesity (WHO criteria)
Time Frame: 9 months
|
9 months
|
|
Cardiovascular reactivity (changes and maximal levels of blood pressure, heart rate)
Time Frame: 9 months
|
9 months
|
|
Perceived stress (stress scale from 1-7)
Time Frame: 9 months
|
9 months
|
|
Moderator role of serious life events and parental worries
Time Frame: 9 months
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2012
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
August 29, 2012
First Submitted That Met QC Criteria
September 22, 2012
First Posted (Estimate)
September 26, 2012
Study Record Updates
Last Update Posted (Actual)
March 25, 2020
Last Update Submitted That Met QC Criteria
March 23, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 286/12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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