Effect of Physical Activity an Stress in Children

Obesity Clinical Trial

Official title:

Effect of Physical Activity an Stress in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01693926
• Other study ID #: 286/12
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Children
• Obesity
• Physical Activity
• Snacking
• Stress

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