Dietary Intervention With Shop Model - SHOPUS
This study is ongoing, but not recruiting participants.
Sponsor:
University of Copenhagen
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01195610
First received: September 3, 2010
Last updated: April 25, 2012
Last verified: August 2011
| Tracking Information | |||||
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| First Received Date ICMJE | September 3, 2010 | ||||
| Last Updated Date | April 25, 2012 | ||||
| Start Date ICMJE | August 2010 | ||||
| Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in body weight (kg) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ] Change in body weight from randomization to end of intervention |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT01195610 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Achievement of more than 5 % weight loss [ Time Frame: 26 weeks ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Dietary Intervention With Shop Model - SHOPUS | ||||
| Official Title ICMJE | A Six Month Randomized Controlled Dietary Intervention Study of the New Nordic Diet vs Average Danish Diet in Adults (18-65y) Using the Shop Model for Optimal Dietary Adherence | ||||
| Brief Summary | The objective is to investigate whether New Nordic Diet (NND) versus Average Danish Diet (ADD) in adults (18-65 y) with central obesity and components of the metabolic syndrome can improve body weight loss and risk markers of the metabolic syndrome, type 2 diabetes and cardiovascular diseases. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Obesity | ||||
| Intervention ICMJE | Behavioral: Dietary intervention
Instruction to diet for 6 month |
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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 | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | August 2012 | ||||
| Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01195610 | ||||
| Other Study ID Numbers ICMJE | B 260 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Thomas Meinert Larsen, Associate Professor, Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen | ||||
| Study Sponsor ICMJE | University of Copenhagen | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Copenhagen | ||||
| Verification Date | August 2011 | ||||
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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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