Effect of Physical Activity an Stress in Children
1 other identifier
interventional
50
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Sep 2012
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedFirst Posted
Study publicly available on registry
September 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMarch 25, 2020
March 1, 2020
9 months
August 29, 2012
March 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in salivary Cortisol and maximal levels of salivary cortisol in response to the TSST stress test over 2 hours
9 months
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
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 Outcomes (4)
Moderator effect of obesity (WHO criteria)
9 months
Cardiovascular reactivity (changes and maximal levels of blood pressure, heart rate)
9 months
Perceived stress (stress scale from 1-7)
9 months
Moderator role of serious life events and parental worries
9 months
Study Arms (2)
Acute physical activity intervention
EXPERIMENTAL25 min of moderate physical activity
Placebo
PLACEBO COMPARATOR25 min of reading (instead of physical activity)
Interventions
25 min of physical activity. The placebo arm will have 25 min of reading.
Eligibility Criteria
You may qualify if:
- year old children
You may not qualify if:
- Severe illness
- Medications interfering with study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Univeristy of Lausanne, SUPEA
Lausanne, Canton of Vaud, 1011, Switzerland
Related Publications (1)
Horsch A, Wobmann M, Kriemler S, Munsch S, Borloz S, Balz A, Marques-Vidal P, Borghini A, Puder JJ. Impact of physical activity on energy balance, food intake and choice in normal weight and obese children in the setting of acute social stress: a randomized controlled trial. BMC Pediatr. 2015 Feb 19;15:12. doi: 10.1186/s12887-015-0326-7.
PMID: 25879821DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medin adjoint
Study Record Dates
First Submitted
August 29, 2012
First Posted
September 26, 2012
Study Start
September 1, 2012
Primary Completion
June 1, 2013
Study Completion
December 1, 2017
Last Updated
March 25, 2020
Record last verified: 2020-03