ObesityNCT00801645
Effects of Exercise on Arterial Function and Insulin Resistance Syndrome in Pre-pubertal Obese Children
A study testing Exercise in people with Obesity, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The main purpose of this project is to investigate the effects of an exercise program on arterial function and cardiovascular diseases risk factors in obese and lean pre-pubertal children. This information will be used to underpin prevention strategies to reduce cardiovascular diseases in overweight youth. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2004to Jun 2010
- 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 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- obese children: Pre-pubertal (Tanner stage 1), BMI > 97th age- and gender-specific percentile (Kromeyer-Hauschild et al. 2001).
- lean subjects: Pre-pubertal (Tanner stage 1), BMI > 10th and < 90th age- and gender-specific percentile.
Who cannot join
- being involved in any weight control, physical activity, or behavioral therapy
- familial history of dyslipidemia or essential hypertension
- medications or hormones, which may influence cardiovascular function, body composition, lipid or glucose metabolism
- orthopedic affection limiting physical activity
- genetic disorder or a chronic disease
- following a therapy for psychiatric problems
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Child and Adolescent, University Hospital of Geneva
Geneva, Canton of Geneva, 1205
About this study
Official title: Effects of Aerobic Exercise Training on Arterial Function and Insulin Resistance Syndrome in Obese Children: A Randomized Controlled Trial
The main purpose of this project is to investigate the effects of an exercise program on arterial function and cardiovascular diseases risk factors in obese and lean pre-pubertal children. This information will be used to underpin prevention strategies to reduce cardiovascular diseases in overweight youth.
Read the detailed description
Introduction: cardiovascular diseases (CVD) are the major contributor to the global burden of non-communicable diseases, one third of all global death being attributed to CVD. Childhood obesity poses a major public health problem and there is increasing evidence that foundation of cardiovascular diseases lays early in life in obese children. There is therefore an urgent need to identify effective prevention strategies. Physical activity is recognized as major determinants of cardiovascular health in adults and adolescents however, little is known in young children. The main purpose of this project is to investigate the effects of a 3-month exercise training program on arterial function and cardiovascular diseases risk factors in obese and lean children.
Methods: This is a randomized controlled trial including 4 groups of pre-pubertal children aged 6 to 11 years old: 1) obese exercise, 2) obese control, 3) lean exercise, and 4) lean control. The exercise groups engage in aerobic exercise training three 60-minute sessions per week for 12 weeks, in addition of school physical education. Training sessions consist of 30 minutes of aerobic exercise (walking, running, games, swimming), followed by strength training and stretching. Controls are relatively inactive. After the 3-month intervention, the obese control group engages in an identical 12-week exercise program and the obese exercise group is encouraged to continue for a total of 6 months. Primary measures include: 24-hour ambulatory systolic and diastolic blood pressure; endothelial function and mechanical indices of the brachial and carotid arteries using a B-mode ultrasound imager; central blood pressure and pulse wave velocity by tonometry of aplanation. Other measures include: body composition, physical activity, cardio-respiratory fitness, nutrition, quality of life, and fasting blood lipids, insulin, glucose, markers of vascular function and inflammation. Testing is performed at baseline, 3, 6 and 24 months in obese children and at baseline and 3 months in lean children.
We hypothesize that exercise training will result in improved arterial function, body composition and markers of the metabolic syndrome in obese children. This information will be used to underpin prevention strategies to reduce CVD risk factors in this high-risk population.
- Conditions
- Obesity
- Being tested
- Exercise
- Keywords
- Obesity, Cardiovascular disease, Endothelial function, Blood pressure, Exercise, Physical activity, Metabolic syndrome, Children, Pediatric
- Medical subject headings
- Obesity, Cardiovascular Diseases, Motor Activity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called Physical activity
The exercise groups engage in aerobic exercise training three 60-minute sessions per week for 12 weeks, in addition of school physical education. Training sessions consist of 30 minutes of aerobic exercise (walking, running, games, swimming), followed by strength training and stretching.
| Study group | Role | What they receive |
|---|---|---|
| Obese exercise | Experimental | Not described Receives: Behavioral: Exercise |
| Obese Control | No intervention | Not described |
| Lean Exercise | Experimental | Not described Receives: Behavioral: Exercise |
| Lean Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial function
Measured: 0-3-6-24 months
Secondary outcomes (9)
Body composition
Measured: 0-3-6-24 months
Body mass index
Measured: 0-3-6-24 months
Cardiorespiratory fitness
Measured: 0-3-6-24 months
Physical activity
Measured: 0-3-6-24 months
Insulin resistance
Measured: 0-3-6-24 months
Blood lipids
Measured: 0-3-6-24 months
Biological markers of endothelial function
Measured: 0-3-6-24 months
High sensitive C-reactive protein
Measured: 0-3-6-24 months
Resting and ambulatory blood pressure
Measured: 0-3-6-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startAug 2004
- Primary completionOct 2008
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Principal investigator, Nathalie Farpour-Lambert, University Hospital, Geneva
- Investigators
- Maurice Beghetti, PD, Study director, Pediatric Cardiology Unit, Departement of Child and Adolescent, University Hospital, GenevaNathalie J Farpour-Lambert, MD, Principal investigator, Pediatric Cardiology Unit, Department of Child and Adolescent, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801645
- Sponsor's protocol ID
- SNF 3200B0-103853
- Status last verified
- Jan 2012
- First submitted
- 2 Dec 2008
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Maggio AB, Aggoun Y, Martin XE, Marchand LM, Beghetti M, Farpour-Lambert NJ. Long-term follow-up of cardiovascular risk factors after exercise training in obese children. Int J Pediatr Obes. 2011 Jun;6(2-2):e603-10. doi: 10.3109/17477166.2010.530665. Epub 2010 Dec 10.
PubMed 21142752Farpour-Lambert NJ, Aggoun Y, Marchand LM, Martin XE, Herrmann FR, Beghetti M. Physical activity reduces systemic blood pressure and improves early markers of atherosclerosis in pre-pubertal obese children. J Am Coll Cardiol. 2009 Dec 15;54(25):2396-406. doi: 10.1016/j.jacc.2009.08.030.
PubMed 20082930
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Exercise Training on Arterial Function and Insulin Resistance Syndrome in Obese Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00801645
- Acronym / sponsor ID
- SNF 3200B0-103853
- Conditions
- Obesity
- Keywords
- Obesity, Cardiovascular disease, Endothelial function, Blood pressure, Exercise, Physical activity, Metabolic syndrome, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- Aug 2004
- Primary completion
- Oct 2008 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 3 Dec 2008 (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 main purpose of this project is to investigate the effects of an exercise program on arterial function and cardiovascular diseases risk factors in obese and lean pre-pubertal children. This information will be used to underpin prevention strategies to reduce cardiovascular diseases in overweight youth.
Detailed description
Introduction: cardiovascular diseases (CVD) are the major contributor to the global burden of non-communicable diseases, one third of all global death being attributed to CVD. Childhood obesity poses a major public health problem and there is increasing evidence that foundation of cardiovascular diseases lays early in life in obese children. There is therefore an urgent need to identify effective prevention strategies. Physical activity is recognized as major determinants of cardiovascular health in adults and adolescents however, little is known in young children. The main purpose of this project is to investigate the effects of a 3-month exercise training program on arterial function and cardiovascular diseases risk factors in obese and lean children.
Methods: This is a randomized controlled trial including 4 groups of pre-pubertal children aged 6 to 11 years old: 1) obese exercise, 2) obese control, 3) lean exercise, and 4) lean control. The exercise groups engage in aerobic exercise training three 60-minute sessions per week for 12 weeks, in addition of school physical education. Training sessions consist of 30 minutes of aerobic exercise (walking, running, games, swimming), followed by strength training and stretching. Controls are relatively inactive. After the 3-month intervention, the obese control group engages in an identical 12-week exercise program and the obese exercise group is encouraged to continue for a total of 6 months. Primary measures include: 24-hour ambulatory systolic and diastolic blood pressure; endothelial function and mechanical indices of the brachial and carotid arteries using a B-mode ultrasound imager; central blood pressure and pulse wave velocity by tonometry of aplanation. Other measures include: body composition, physical activity, cardio-respiratory fitness, nutrition, quality of life, and fasting blood lipids, insulin, glucose, markers of vascular function and inflammation. Testing is performed at baseline, 3, 6 and 24 months in obese children and at baseline and 3 months in lean children.
We hypothesize that exercise training will result in improved arterial function, body composition and markers of the metabolic syndrome in obese children. This information will be used to underpin prevention strategies to reduce CVD risk factors in this high-risk population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Obese exercise | Experimental | Behavioral: Exercise |
| Obese Control | No intervention | – |
| Lean Exercise | Experimental | Behavioral: Exercise |
| Lean Control | No intervention | – |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- obese children: Pre-pubertal (Tanner stage 1), BMI > 97th age- and gender-specific percentile (Kromeyer-Hauschild et al. 2001).
- lean subjects: Pre-pubertal (Tanner stage 1), BMI > 10th and < 90th age- and gender-specific percentile.
Key exclusion criteria (6 listed)
- being involved in any weight control, physical activity, or behavioral therapy
- familial history of dyslipidemia or essential hypertension
- medications or hormones, which may influence cardiovascular function, body composition, lipid or glucose metabolism
- orthopedic affection limiting physical activity
- genetic disorder or a chronic disease
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 |
|---|---|---|
| ExerciseAlso: Physical activityThe exercise groups engage in aerobic exercise training three 60-minute sessions per week for 12 weeks, in addition of school physical education. Training sessions consist of 30 minutes of aerobic exercise (walking, running, games, swimming), followed by strength training and stretching. | Behavioural | Lean Exercise, Obese exercise |
Primary outcome
Arterial function
Time frame: 0-3-6-24 months
9 secondary outcomes
Body composition
Time frame: 0-3-6-24 months
Body mass index
Time frame: 0-3-6-24 months
Cardiorespiratory fitness
Time frame: 0-3-6-24 months
Physical activity
Time frame: 0-3-6-24 months
Insulin resistance
Time frame: 0-3-6-24 months
Blood lipids
Time frame: 0-3-6-24 months
Biological markers of endothelial function
Time frame: 0-3-6-24 months
High sensitive C-reactive protein
Time frame: 0-3-6-24 months
Resting and ambulatory blood pressure
Time frame: 0-3-6-24 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 5 Jan 2012.
- Derived from this study: PubMed 21142752Maggio AB, Aggoun Y, Martin XE, Marchand LM, Beghetti M, Farpour-Lambert NJ. Long-term follow-up of cardiovascular risk factors after exercise training in obese children. Int J Pediatr Obes. 2011 Jun;6(2-2):e603-10. doi: 10.3109/17477166.2010.530665. Epub 2010 Dec 10.
- Derived from this study: PubMed 20082930Farpour-Lambert NJ, Aggoun Y, Marchand LM, Martin XE, Herrmann FR, Beghetti M. Physical activity reduces systemic blood pressure and improves early markers of atherosclerosis in pre-pubertal obese children. J Am Coll Cardiol. 2009 Dec 15;54(25):2396-406. doi: 10.1016/j.jacc.2009.08.030.
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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.
Maurice Beghetti, PD study director
Pediatric Cardiology Unit, Departement of Child and Adolescent, University Hospital, Geneva
Nathalie J Farpour-Lambert, MD principal investigator
Pediatric Cardiology Unit, Department of Child and Adolescent, University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Obesity, run by University Hospital, Geneva 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 2 inclusion and 6 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 5 Jan 2012. 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. 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?
Arterial function (time frame: 0-3-6-24 months). 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 NCT00801645, which also lists 2 linked publications.
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 5 Jan 2012.