ObesityNCT01693926
Effect of Physical Activity an Stress in Children
A study testing Acute physical activity intervention in people with Obesity and Children, run by University of Lausanne Hospitals at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Children, Physical Activity
- What is being tested?
- Acute physical activity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2012to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 7-10 year old children
Who cannot join
- Severe illness
- Medications interfering with study
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Univeristy of Lausanne, SUPEA
Lausanne, Canton of Vaud, 1011
About this study
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.
Read the 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
- Conditions
- Obesity, Children, Physical Activity, Stress, Snacking
- Being tested
- Acute physical activity intervention, placebo
- Keywords
- Obesity, Children, Physical activity, Stress, Snacking
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute physical activity interventionBehavioural
25 min of physical activity. The placebo arm will have 25 min of reading.
placeboBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Acute physical activity intervention | Experimental | 25 min of moderate physical activity Receives: Behavioral: Acute physical activity intervention |
| Placebo | Placebo comparator | 25 min of reading (instead of physical activity) Receives: Behavioral: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in salivary Cortisol and maximal levels of salivary cortisol in response to the TSST stress test over 2 hours
Measured: 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
Measured: 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).
Measured: 9 months
Secondary outcomes (4)
Moderator effect of obesity (WHO criteria)
Measured: 9 months
Cardiovascular reactivity (changes and maximal levels of blood pressure, heart rate)
Measured: 9 months
Perceived stress (stress scale from 1-7)
Measured: 9 months
Moderator role of serious life events and parental worries
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2013
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jardena Puder, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693926
- Sponsor's protocol ID
- 286/12
- Status last verified
- Mar 2020
- First submitted
- 29 Aug 2012
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25879821
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physical Activity an Stress in Children
- ClinicalTrials.gov ID
- NCT01693926
- Acronym / sponsor ID
- 286/12
- Conditions
- Obesity, Children, Physical Activity, Stress, Snacking
- Keywords
- Obesity, Children, Physical activity, Stress, Snacking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Sep 2012 (actual)
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 26 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute physical activity intervention | Experimental | Behavioral: Acute physical activity intervention25 min of moderate physical activity |
| Placebo | Placebo comparator | Behavioral: placebo25 min of reading (instead of physical activity) |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 7-10 year old children
Key exclusion criteria (2 listed)
- Severe illness
- Medications interfering with study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute physical activity intervention25 min of physical activity. The placebo arm will have 25 min of reading. | Behavioural | Acute physical activity intervention |
| placebo | Behavioural | Placebo |
Primary outcome
Change in salivary Cortisol and maximal levels of salivary cortisol in response to the TSST stress test over 2 hours
Time frame: 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
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).
4 secondary outcomes
Moderator effect of obesity (WHO criteria)
Time frame: 9 months
Cardiovascular reactivity (changes and maximal levels of blood pressure, heart rate)
Time frame: 9 months
Perceived stress (stress scale from 1-7)
Time frame: 9 months
Moderator role of serious life events and parental worries
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Derived from this study: PubMed 25879821Horsch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute physical activity intervention in people with Obesity and Children, run by University of Lausanne Hospitals at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in salivary Cortisol and maximal levels of salivary cortisol in response to the TSST stress test over 2 hours (time frame: 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01693926, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.