Randomized, Controlled, Open, Comparative Intervention Study for Obesity Prevention in Children
NCT ID: NCT00438555
Last Updated: 2015-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
248 participants
INTERVENTIONAL
2006-10-31
2014-12-31
Brief Summary
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Detailed Description
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Objectives:
1. To develop an intervention program for obesity prevention in children aged 5-10 years old, who are at risk to develop obesity
2. To compare between the efficacy of two different intervention programs and a control group in preventing obesity in the short and the long term.
3. To evaluate the role and significance of including parents in an intervention program for obesity prevention.
4. To identify demographic parameters, lifestyle characteristic and biochemical markers that predict the risk of developing obesity and the response for treatment.
Randomization:
Patients will be randomly allocated into one of two intervention groups or control group in ratio of 1:1:1. Each group will contain 12-15 participants.
Intervention groups:
1. parent's group- only parents will take part at the intervention program.
2. Parents and children group- both children and parents will take part at the intervention program, in two separate sessions.
Methods:
1. The study will be consist of two main periods: an intervention period of 3 months followed by 21 months of a follow up period. During the intervention period, participants (parents or both parents and children, depending on randomization) will attend a behavior intervention program once a week, each session will last one hour and would be guided by dietician and psychologist. Follow up visits will be performed at the clinic (for participants in all 3 groups) at months 0, 3, 12 and 24.
2. Height, weight, fat mass and waist circumference will be measured at 0, 3, 12 and 24 month. Height and weight of parents will also be measured at these visits.
3. Physical examination will be performed at 0, 3, 12 and 24 month.
4. Psychological and nutritional questionnaire (depression, quality of life and self estimation) will be filled at 0, 3, 12 and 24 month.
5. Fasting blood tests for: chemistry, hematology, lipids, glucose, insulin, TSH, adiponectin, IL-6 and TNFα will be performed at 0, 3, 12 and 24 month.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Parent's group
3 months workshop of parents intervention, guided by dietician and phycologist
Parent's group
3 months workshop of parents intervention, guided by dietician and phycologist
Parents and children group
3 months workshops of parents and children intervention, guided by dietician and phycologist
Parents and children group
3 months workshops of parents and children intervention, guided by dietician and phycologist
Control group
control group, no intervention, medical follow up only
No interventions assigned to this group
Interventions
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Parents and children group
3 months workshops of parents and children intervention, guided by dietician and phycologist
Parent's group
3 months workshop of parents intervention, guided by dietician and phycologist
Eligibility Criteria
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Inclusion Criteria
* BMI in 85-98 percentile
* Both parents signing informed consent form
Exclusion Criteria
* Incapability to perform all study procedure
5 Years
10 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Rabin Medical Center
OTHER
Responsible Party
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Principal Investigators
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Moshe Phillip, Prof, MD
Role: PRINCIPAL_INVESTIGATOR
Schneider Children Medical Center
Joseph Meyerovitch, Dr, MD
Role: PRINCIPAL_INVESTIGATOR
Schneider Children Medical Center
Locations
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schneider children medical center of Israel
Petah Tikva, , Israel
Countries
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Other Identifiers
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rmc004055ctil
Identifier Type: -
Identifier Source: org_study_id
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