Pediatric ObesityNCT00461994
The Role of Exercise and Diet in Weight Loss in Obese Children
A study testing diet, exercise and diet and exercise in people with Pediatric Obesity, run by Rabin Medical Center at 2 sites in Israel.
Trial summary
A 3-arms randomized prospective intervention study to determine the roles of exercise and/or diet on weight loss and weight maintenance in obese preadolescent children 6-11 year-old with BMI> 95th percentile for age and gender. Children were randomly allocated into three groups. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- diet, exercise and diet and exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 160 participants
- Where
- 2 sitesIsrael
- Study dates
- Apr 2004to Dec 2006
- 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 preadolescent children 6-11 year-old with BMI> 95th percentile for age and gender.
- A signed informed consent will be taken from patients and their parents.
- Agreement to a follow-up of one year.
Who cannot join
- Cardiac problems (arrhythmia, Congestive heart disease)
- Uncontrolled hypertension
- Severe hepatic impairment (liver enzymes above 3 folds the upper normal values)
- Renal failure
- Genetic syndromes associated with obesity
- Presence of untreated hypothyroidism
- Participation in a clinical study during the last month
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Soroka Medical Center
Beersheba
Schneider Children's Medical Center
Petah Tikva, 49202
About this study
Official title: The Role of Exercise and/or Diet in Weight Loss, and Weight Maintenance in Obese Preadolescent Children
A 3-arms randomized prospective intervention study to determine the roles of exercise and/or diet on weight loss and weight maintenance in obese preadolescent children 6-11 year-old with BMI> 95th percentile for age and gender. Children were randomly allocated into three groups. The first group underwent an exercise program, the second one underwent both an exercise program and a diet program and the third underwent a diet program alone.
The total duration of the intervention is 12 weeks followed by a period of 9 months of follow-up. The effects of the different intervention on weight loss and weight maintenance,body composition, on hormonal components that regulate the caloric balance, on metabolic profile and cardiovascular risk factors and on psychological parameters were also determined.
Read the detailed description
A 3-arms randomized prospective intervention study including 161 patients in order to determine the roles of exercise and/or diet on weight loss and weight maintenance in obese preadolescent children 6-11 year-old with BMI> 95th percentile for age and gender. The study recruited patients from 2 endocrine clinics.
Objectives:
- The main aim was to determine the roles of exercise and/or diet on weight loss and weight maintenance in obese children.
- Secondary goals were:
- To determine the effects of exercise and/or diet on body composition.
- To determine the effects of exercise and/or diet on leptin and ghrelin that play a role in the regulation of energy balance.
- To determine the effects of exercise and/or diet on metabolic profile, cardiovascular risk factors, and inflammatory markers as fasting glucose,insulin and lipid profile,homocysteine ,adiponectin levels,CRP,and IL-6.
- To determine the role of exercise and/or diet on psychological parameters of obese children.
Study Population
Inclusion Criteria
- Obese preadolescent children 6-11 year-old with BMI> 95th percentile for age and gender.
- A signed informed consent will be taken from patients and their parents.
- Agreement to a follow-up of one year.
Exclusion Criteria
- Cardiac problems (arrhythmia, Congestive heart disease)
- Uncontrolled hypertension
- Severe hepatic impairment (liver enzymes above 3 folds the upper normal values)
- Renal failure
- Genetic syndromes associated with obesity
- Presence of untreated hypothyroidism
- Participation in a clinical study during the last month methods Children fulfilling the inclusion and exclusion criteria were randomly allocated into one of three groups.
The first group underwent an exercise program, the second one underwent both an exercise program and a diet program and the third underwent a diet program alone.
On the first visit of the study, at the end of the intervention (12 weeks) and at the end of the follow-up period (1 year) the following had been checked:
Weight, Height, Body impedance, Waist and hip circumferences, Skin-folds, Blood pressure, Basal Metabolic Rate (evaluated by a metabolic monitor), and blood samples for: Blood count, Liver function, Renal function, Fasting Lipid, glucose and insulin,CRP, IL-6, TSH, free T4, Homocysteine, Adiponectin, Leptin and Ghrelin. Also at these point of time every patient underwent a psychosocial evaluation with life style questioners.
Safety:There were no complications with these modes of treatment.
- Conditions
- Pediatric Obesity
- Being tested
- diet, exercise, diet and exercise
- Keywords
- OBESITY, CHILDREN, METABOLIC PARAMETERS, DIET, EXERCISE
- Medical subject headings
- Pediatric Obesity, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietBehavioural
exerciseBehavioural
diet and exerciseBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
BMI-SDS
BODY FAT PERCENTAGE
WAIST AND HIP CIRCUMFERENCES
Secondary outcomes (5)
BLOOD METABOLIC PROFILE
BLOOD INFLAMATORY MARKERS
GHRELIN AND LEPTIN LEVELS
RESTING ENERGY EXPENDITURE
PSYCHOLOGICAL PARAMETERS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2007 (estimated)
- Study startApr 2004
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric 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
- 160 participants
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- D-Cure, Israel, Soroka University Medical Center
- Investigators
- Moshe Phillip, Prof, MD, Principal investigator, Schneider Children Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00461994
- Sponsor's protocol ID
- rmc003189CTil
- Status last verified
- Apr 2007
- First submitted
- 17 Apr 2007
- Last updated
- 18 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Exercise and/or Diet in Weight Loss, and Weight Maintenance in Obese Preadolescent Children
- ClinicalTrials.gov ID
- NCT00461994
- Acronym / sponsor ID
- rmc003189CTil
- Conditions
- Pediatric Obesity
- Keywords
- OBESITY, CHILDREN, METABOLIC PARAMETERS, DIET, EXERCISE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- D-Cure, Israel, Soroka University Medical Center
- Study start
- Apr 2004
- Study completion
- Dec 2006 (actual)
- First posted
- 18 Apr 2007 (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.
A 3-arms randomized prospective intervention study to determine the roles of exercise and/or diet on weight loss and weight maintenance in obese preadolescent children 6-11 year-old with BMI> 95th percentile for age and gender. Children were randomly allocated into three groups. The first group underwent an exercise program, the second one underwent both an exercise program and a diet program and the third underwent a diet program alone.
The total duration of the intervention is 12 weeks followed by a period of 9 months of follow-up. The effects of the different intervention on weight loss and weight maintenance,body composition, on hormonal components that regulate the caloric balance, on metabolic profile and cardiovascular risk factors and on psychological parameters were also determined.
Detailed description
A 3-arms randomized prospective intervention study including 161 patients in order to determine the roles of exercise and/or diet on weight loss and weight maintenance in obese preadolescent children 6-11 year-old with BMI> 95th percentile for age and gender. The study recruited patients from 2 endocrine clinics.
Objectives:
- The main aim was to determine the roles of exercise and/or diet on weight loss and weight maintenance in obese children.
- Secondary goals were:
- To determine the effects of exercise and/or diet on body composition.
- To determine the effects of exercise and/or diet on leptin and ghrelin that play a role in the regulation of energy balance.
- To determine the effects of exercise and/or diet on metabolic profile, cardiovascular risk factors, and inflammatory markers as fasting glucose,insulin and lipid profile,homocysteine ,adiponectin levels,CRP,and IL-6.
- To determine the role of exercise and/or diet on psychological parameters of obese children.
Study Population
Inclusion Criteria
- Obese preadolescent children 6-11 year-old with BMI> 95th percentile for age and gender.
- A signed informed consent will be taken from patients and their parents.
- Agreement to a follow-up of one year.
Exclusion Criteria
- Cardiac problems (arrhythmia, Congestive heart disease)
- Uncontrolled hypertension
- Severe hepatic impairment (liver enzymes above 3 folds the upper normal values)
- Renal failure
- Genetic syndromes associated with obesity
- Presence of untreated hypothyroidism
- Participation in a clinical study during the last month methods Children fulfilling the inclusion and exclusion criteria were randomly allocated into one of three groups.
The first group underwent an exercise program, the second one underwent both an exercise program and a diet program and the third underwent a diet program alone.
On the first visit of the study, at the end of the intervention (12 weeks) and at the end of the follow-up period (1 year) the following had been checked:
Weight, Height, Body impedance, Waist and hip circumferences, Skin-folds, Blood pressure, Basal Metabolic Rate (evaluated by a metabolic monitor), and blood samples for: Blood count, Liver function, Renal function, Fasting Lipid, glucose and insulin,CRP, IL-6, TSH, free T4, Homocysteine, Adiponectin, Leptin and Ghrelin. Also at these point of time every patient underwent a psychosocial evaluation with life style questioners.
Safety:There were no complications with these modes of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Obese preadolescent children 6-11 year-old with BMI> 95th percentile for age and gender.
- A signed informed consent will be taken from patients and their parents.
- Agreement to a follow-up of one year.
Key exclusion criteria (7 listed)
- Cardiac problems (arrhythmia, Congestive heart disease)
- Uncontrolled hypertension
- Severe hepatic impairment (liver enzymes above 3 folds the upper normal values)
- Renal failure
- Genetic syndromes associated with obesity
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 |
|---|---|---|
| diet | Behavioural | – |
| exercise | Behavioural | – |
| diet and exercise | Behavioural | – |
Primary outcome
BMI
BMI-SDS
BODY FAT PERCENTAGE
WAIST AND HIP CIRCUMFERENCES
5 secondary outcomes
BLOOD METABOLIC PROFILE
BLOOD INFLAMATORY MARKERS
GHRELIN AND LEPTIN LEVELS
RESTING ENERGY EXPENDITURE
PSYCHOLOGICAL PARAMETERS
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 18 Apr 2007.
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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.
Moshe Phillip, Prof, MD principal investigator
Schneider Children Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diet, exercise and diet and exercise in people with Pediatric Obesity, run by Rabin Medical Center at 2 sites in Israel.
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 3 inclusion and 7 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 18 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
BMI. The study lists 4 primary outcomes in all. 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 18 Apr 2007.