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Dietary Intervention With Shop Model - SHOPUS (SHOPUS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01195610
First Posted: September 6, 2010
Last Update Posted: July 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Copenhagen
  Purpose
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.

Condition Intervention
Obesity Behavioral: Dietary intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Change in body weight (kg) [ Time Frame: 26 weeks ]
    Change in body weight from randomization to end of intervention


Secondary Outcome Measures:
  • Change in body fat percentage [ Time Frame: 26 weeks ]
    Change in body fat percentage (DEXA-scanning)

  • Dietary compliance [ Time Frame: 26 weeks ]
    Level of dietary compliance

  • Changes in components of the metabolic syndrome [ Time Frame: 26 weeks ]
    Changes in the number of components of the metabolic syndrome

  • Achievement of 5% weight loss [ Time Frame: 26 weeks ]
    Achievement of 5% weight loss from randomization to end of intervention


Enrollment: 181
Study Start Date: August 2010
Study Completion Date: July 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: New Nordic Diet
New Nordic Diet
Behavioral: Dietary intervention
Instruction to diet for 6 month
Experimental: Average Danish Diet
Average Danish Diet
Behavioral: Dietary intervention
Instruction to diet for 6 month

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • abdominal obesity

Exclusion Criteria:

  • BMI > 45, previous weight change
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01195610


Locations
Denmark
Department of Human Nutrition
Frederiksberg, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Investigators
Principal Investigator: Thomas Meinert Larsen, PhD Department of Human Nutrition, University of Copenhagen