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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01693926
Other study ID # 286/12
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2012
Est. completion date December 2017

Study information

Verified date March 2020
Source University of Lausanne Hospitals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 2017
Est. primary completion date June 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 10 Years
Eligibility Inclusion Criteria:

- 7-10 year old children

Exclusion Criteria:

- Severe illness

- Medications interfering with study

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Acute physical activity intervention
25 min of physical activity. The placebo arm will have 25 min of reading.
placebo


Locations

Country Name City State
Switzerland Univeristy of Lausanne, SUPEA Lausanne VD

Sponsors (1)

Lead Sponsor Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in salivary Cortisol and maximal levels of salivary cortisol in response to the TSST stress test over 2 hours 9 months
Primary 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 9 months
Primary 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). 9 months
Secondary Moderator effect of obesity (WHO criteria) 9 months
Secondary Cardiovascular reactivity (changes and maximal levels of blood pressure, heart rate) 9 months
Secondary Perceived stress (stress scale from 1-7) 9 months
Secondary Moderator role of serious life events and parental worries 9 months
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