The Activity School in Finnmark for Overweight Children
| Tracking Information | |||||
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| First Received Date ICMJE | March 30, 2009 | ||||
| Last Updated Date | December 4, 2012 | ||||
| Start Date ICMJE | April 2009 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in Body Mass Index compared to baseline [ Time Frame: 3 years ] [ Designated as safety issue: No ] BMI will be measured at baseline and at 3 months- , 1 year-, 2 year- and 3-year follow-up. Primary measures at 2 years of continuous lifestyle modification. Last measurement at 1 year after last counselling and active treatment has stopped, 3 years from baseline. |
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| Original Primary Outcome Measures ICMJE |
Change in Body Mass Index (BMI) [ Time Frame: After 2 years, last control after 3 years ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00872807 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE |
Change in lipid levels compared to baseline [ Time Frame: 3 years ] [ Designated as safety issue: No ] Measurements of total cholesterol, Triglycerides, HDL and LDL at baseline, 1 year-, 2 year- and 3-year follow-up. Primary measures at 2 years of continuous lifestyle modification. Last measurement at 1 year after last counseling and active treatment has stopped, 3 years from baseline |
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| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Activity School in Finnmark for Overweight Children | ||||
| Official Title ICMJE | The Activity School in Finnmark for Overweight and Obese Children and Their Families | ||||
| Brief Summary | The purpose of this study is to evaluate the effectiveness of a life style counseling programme designed for overweight and obese children and their parents in groups compared to traditional individual counseling in the pediatric outpatient clinic and the community. The two interventions are both hospital and community based. |
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| Detailed Description | Randomized study design with two parallel groups.Active intervention in two years, last follow-up after 3 years. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 97 | ||||
| Estimated Completion Date | December 2013 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 6 Years to 12 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Norway | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00872807 | ||||
| Other Study ID Numbers ICMJE | 2007/5.2006.3473 (REK), 15873 (NSD) | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University Hospital of North Norway | ||||
| Study Sponsor ICMJE | University Hospital of North Norway | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University Hospital of North Norway | ||||
| Verification Date | December 2012 | ||||
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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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