Randomized, Controlled, Open, Comparative Intervention Study for Obesity Prevention in Children
NCT00438555
ABOUT THIS STUDY
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- Children aged 5-10 years old
- BMI in 85-98 percentile
- Both parents signing informed consent form
- Chronic disease or chronic use of medication
- Incapability to perform all study procedure
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Descriptive Information | |||||||
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Brief Title ICMJE | Randomized, Controlled, Open, Comparative Intervention Study for Obesity Prevention in Children | ||||||
Official Title ICMJE | Randomized, Controlled, Open, Comparative Intervention Study for Obesity Prevention in Children | ||||||
Brief Summary | Randomized, controlled, open, comparative intervention study in 270 children at risk for obesity.Patients will be randomly allocated into one of two behavior intervention groups or control group in ratio of 1:1:1.The study will 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 al 3 groups) at months 0, 3, 12 and 24. | ||||||
Detailed Description | Randomized, controlled, open, comparative intervention study in 270 children at risk for obesity. Objectives:
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:
Methods:
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention | ||||||
Condition ICMJE | Obesity | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 248 | ||||||
Original Enrollment ICMJE | 270 | ||||||
Actual Study Completion Date ICMJE | December 2014 | ||||||
Actual Primary Completion Date | October 2014 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 5 Years to 10 Years (Child) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Israel | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00438555 | ||||||
Other Study ID Numbers ICMJE | rmc004055ctil | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Rabin Medical Center | ||||||
Study Sponsor ICMJE | Rabin Medical Center | ||||||
Collaborators ICMJE | Pfizer | ||||||
Investigators ICMJE |
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PRS Account | Rabin Medical Center | ||||||
Verification Date | July 2014 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |