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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 25, 2006 | ||||
| Last Updated Date | May 31, 2007 | ||||
| Start Date ICMJE | September 2006 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
changes in BMI, activity level and Quality of Life questionnaire for the parents and the others children in the family | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00344747 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Multidisciplinary Ambulatory Intervention Program in Family of Children and Adolescents With Obesity | ||||
| Official Title ICMJE | Multidisciplinary Ambulatory Intervention Program (Dietary Behavioral Physical Activity) in Family of Children and Adolescents With Obesity | ||||
| Brief Summary | Obesity has become a pandemic, and it is today’s principal neglected public health problem. Obesity has increased dramatically during the past two decades At adolescence, it is an aggravating issue, because obesity tends to persist in adulthood and the longer its duration, the higher the associated mortality and morbidity. Obesity imposes a heavy health and social burden, and it is widely recognized that treatment is costly. If obesity is not successfully addressed by late adolescence, the likelihood of weight loss in adulthood is as low as 5%. Therefore, prevention is crucial, and children and adolescents should be a priority target. Treatment of obesity is costly, time consuming, difficult and the results aren’t always satisfying On most cases the patients receive dietary advice only (6-10 visits per year). And usually the patients end the treatment early due to lack of results. The best treatment of children and adolescent obesity is done in highly specialized settings, by a multidisciplinary team. Those programs have a limited number of locations (not always in proximity to the patients’ residence), in addition, they are long term treatments and therefore are hard to complete successfully without additional support, Therefore only a limited number of patients can benefit from such programs. Due to the reasons mentioned above, many families tend not to start the process of treating their obese child, or turn to commercial weight loss programs, or put their children according to their beliefs and diets. Therefore ambulatory medicine is the ideal setting for the treatment of children and adolescent’s obesity, it’s also in proximity to the patients’ residence, the medical team has a deep knowing of their patients and the possibility for long term maintenance and follow-up. We propose a trial of obesity treatment by behavior modification program, including parents as agents of change. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Obesity | ||||
| Intervention ICMJE | Behavioral: dietary, behavioral, physical activity | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Estimated Completion Date | April 2008 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:Children (6-18 years) with BMI in the 85th to 95th percentile or higher Exclusion Criteria:Children with chronic diseases treated with chronic medications. Refuse to participate in to the study |
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| Gender | Both | ||||
| Ages | 6 Years to 18 Years | ||||
| Accepts Healthy Volunteers | |||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00344747 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | SOR433806CTIL | ||||
| Study Sponsor ICMJE | Soroka University Medical Center | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Soroka University Medical Center | ||||
| Verification Date | May 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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