Childhood ObesityNCT01506245
Exercise and Behavioral Therapy in Obese Children
A study testing Family-based behavioral therapy in people with Childhood Obesity, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The aim of this study is to compare the effects of exercise training and family-based behavioral treatment, either in individual or in group setting, in pre-pubertal children and their mother. Read more about this study
- Who is it for?
- Ages 8 to 11 years
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Family-based behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2011to Dec 2012
- 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 8 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Childhood obesity (>97 percentile WHO references)
Who cannot join
- being involved in any weight control, physical activity, behavior therapy, or gastric surgery program;
- familial history of dyslipidemia or essential hypertension;
- medications or hormones, which may influence cardiovascular function, body composition, lipid or glucose metabolism in the preceding 6 months;
- orthopaedic affection limiting physical activity;
- genetic disorder or another chronic disease;
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Geneva
Geneva, Canton of Geneva, 1205
About this study
Official title: Exercise Training and Family-based Behavioural Treatment in Pre-pubertal Obese Children and Their Mother
The aim of this study is to compare the effects of exercise training and family-based behavioral treatment, either in individual or in group setting, in pre-pubertal children and their mother.
Read the detailed description
Introduction: The prevalence of childhood obesity is increasing rapidly in developing countries. The aim of this study is to determine the effects of exercise training and family-based behavioral treatment (FBBT), either in individual or in group setting,in pre-pubertal children and their mother.
Methods: This is a 6-month randomized controlled trial (RCT) including 75 pre-pubertal obese children (age 8-11 years) randomly assigned to an Intervention (I, n=50) or a Control group (C, n=25). The intervention consists of a family-based behavioural therapy in group (1 session/week with a dietician and a psychologist) or in individual setting (paediatrician or dietician 1x/month). The intervention includes exercise training sessions twice a week (60 minutes each).
Measures include: body mass index (BMI), waist and hip circumferences; whole body and abdominal fat mass by DXA; resting and ambulatory blood pressure; arterial intima-media thickness and vascular reactivity (flow-mediated dilation)using high resolution ultrasound; arterial stiffness by tonometry of applanation; cardiorespiratory fitness by a treadmill test; physical activity; fasting lipids, glucose, insulin, and C-reactive protein levels; health-related quality of life and psychological health using standardized questionnaires and a semi-structured interview. Measures are completed in children and their mother at baseline and 6 months post-randomization.
- Conditions
- Childhood Obesity
- Being tested
- Family-based behavioral therapy
- Keywords
- Obesity, Children, Behavior, Family, Exercise
- Medical subject headings
- Pediatric Obesity, Obesity, Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-based behavioral therapyBehavioural
The intervention consist of a 6-month family-based behavioural therapy either in group (1 session/week, with a dietician and a psychologist) or in individual setting (with a paediatrician or a dietician in alternance 1x/month). Both therapies include exercise training twice per week (60 minutes each). Parents, or at at least the mother, must participate to the behavioral treatment.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Family-based behavioral therapy | Experimental | Family-based behavioural therapy either in group or in individual setting. Parents can choose between the 2 types of therapy. Receives: Behavioral: Family-based behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Body Mass Index at 6 months
Body Mass Index (weight/height 2) expressed in Standard Deviation Score
Measured: 6 months
Secondary outcomes (12)
Change from baseline in total body and abdominal fat at 6 months
Body fat mass and percentage assessed using DXA
Measured: 6 months
Change from baseline in waist circumference at 6 months
Measured: 6 months
Change from baseline in blood pressure at 6 months
Resting and ambulatory (24 hours) systolic and diastolic blood pressure
Measured: 6 months
Change from baseline in arterial intima-media thickness at 6 months
Measure of the arterial intima-media thickness using high-resolution ultrasound
Measured: 6 months
Change from baseline in arterial flow-mediated dilation at 6 months
Measure of the flow-mediated dilation of the brachial artery using high-resolution ultrasound
Measured: 6 months
Change from baseline in arterial stiffness at 6 months
Measure of mechanical indices using tonometry of applanation
Measured: 6 months
Change from baseline in cardiorespiratory fitness at 6 months
Measured: 6 months
Change from baseline in physical activity at 6 months
Physical activity pattern using accelerometer
Measured: 6 months
Change from baseline in biological markers at 6 months
Fasting glucose, insulin, total-, LDL-, HDL-cholesterol, high-sensitive C-reactive protein.
Measured: 6 months
Change from baseline in quality of life at 6 months
Quality of life assessed using the Kidsscreen 52 questionnaire
Measured: 6 months
Change from baseline in child's behavior at 6 months
Child Behavior Checklist filled by parents
Measured: 6 months
Change from baseline in parental psychological health at 6 months
Global Health Questionnaire filled by parents
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2012 (estimated)
- Study startJan 2011
- Primary completionJun 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood 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
- 75 participants (estimated)
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
- Nathalie Farpour-Lambert, MD, Principal investigator, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506245
- Sponsor's protocol ID
- SNF 3200B0-120437
- Status last verified
- Jan 2012
- First submitted
- 31 Dec 2011
- Last updated
- 9 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training and Family-based Behavioural Treatment in Pre-pubertal Obese Children and Their Mother
- ClinicalTrials.gov ID
- NCT01506245
- Acronym / sponsor ID
- SNF 3200B0-120437
- Conditions
- Childhood Obesity
- Keywords
- Obesity, Children, Behavior, Family, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- Jan 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 9 Jan 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 aim of this study is to compare the effects of exercise training and family-based behavioral treatment, either in individual or in group setting, in pre-pubertal children and their mother.
Detailed description
Introduction: The prevalence of childhood obesity is increasing rapidly in developing countries. The aim of this study is to determine the effects of exercise training and family-based behavioral treatment (FBBT), either in individual or in group setting,in pre-pubertal children and their mother.
Methods: This is a 6-month randomized controlled trial (RCT) including 75 pre-pubertal obese children (age 8-11 years) randomly assigned to an Intervention (I, n=50) or a Control group (C, n=25). The intervention consists of a family-based behavioural therapy in group (1 session/week with a dietician and a psychologist) or in individual setting (paediatrician or dietician 1x/month). The intervention includes exercise training sessions twice a week (60 minutes each).
Measures include: body mass index (BMI), waist and hip circumferences; whole body and abdominal fat mass by DXA; resting and ambulatory blood pressure; arterial intima-media thickness and vascular reactivity (flow-mediated dilation)using high resolution ultrasound; arterial stiffness by tonometry of applanation; cardiorespiratory fitness by a treadmill test; physical activity; fasting lipids, glucose, insulin, and C-reactive protein levels; health-related quality of life and psychological health using standardized questionnaires and a semi-structured interview. Measures are completed in children and their mother at baseline and 6 months post-randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Family-based behavioral therapy | Experimental | Behavioral: Family-based behavioral therapyFamily-based behavioural therapy either in group or in individual setting. Parents can choose between the 2 types of therapy. |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Childhood obesity (>97 percentile WHO references)
Key exclusion criteria (5 listed)
- being involved in any weight control, physical activity, behavior therapy, or gastric surgery program;
- familial history of dyslipidemia or essential hypertension;
- medications or hormones, which may influence cardiovascular function, body composition, lipid or glucose metabolism in the preceding 6 months;
- orthopaedic affection limiting physical activity;
- genetic disorder or another 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 |
|---|---|---|
| Family-based behavioral therapyThe intervention consist of a 6-month family-based behavioural therapy either in group (1 session/week, with a dietician and a psychologist) or in individual setting (with a paediatrician or a dietician in alternance 1x/month). Both therapies include exercise training twice per week (60 minutes each). Parents, or at at least the mother, must participate to the behavioral treatment. | Behavioural | Family-based behavioral therapy |
Primary outcome
Change from baseline in Body Mass Index at 6 months
Time frame: 6 months
Body Mass Index (weight/height 2) expressed in Standard Deviation Score
12 secondary outcomes
Change from baseline in total body and abdominal fat at 6 months
Time frame: 6 months
Change from baseline in waist circumference at 6 months
Time frame: 6 months
Change from baseline in blood pressure at 6 months
Time frame: 6 months
Change from baseline in arterial intima-media thickness at 6 months
Time frame: 6 months
Change from baseline in arterial flow-mediated dilation at 6 months
Time frame: 6 months
Change from baseline in arterial stiffness at 6 months
Time frame: 6 months
Change from baseline in cardiorespiratory fitness at 6 months
Time frame: 6 months
Change from baseline in physical activity at 6 months
Time frame: 6 months
Change from baseline in biological markers at 6 months
Time frame: 6 months
Change from baseline in quality of life at 6 months
Time frame: 6 months
Change from baseline in child's behavior at 6 months
Time frame: 6 months
Change from baseline in parental psychological health at 6 months
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2012.
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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.
Nathalie Farpour-Lambert, MD principal investigator
University of Geneva, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-based behavioral therapy in people with Childhood 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 9 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?
Results are not available in the source record.
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 from baseline in Body Mass Index at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2012.