Dietary Intervention With Shop Model - SHOPUS

This study has been completed.
Sponsor:
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01195610
First received: September 3, 2010
Last updated: August 27, 2013
Last verified: August 2011

September 3, 2010
August 27, 2013
August 2010
August 2011   (final data collection date for primary outcome measure)
Change in body weight (kg) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Change in body weight from randomization to end of intervention
  • Change in body weight (kg) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Body fat percentage [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Dietary compliance level [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Components of metabolic syndrome [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01195610 on ClinicalTrials.gov Archive Site
  • Change in body fat percentage [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Change in body fat percentage (DEXA-scanning)
  • Dietary compliance [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Level of dietary compliance
  • Changes in components of the metabolic syndrome [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Changes in the number of components of the metabolic syndrome
  • Achievement of 5% weight loss [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Achievement of 5% weight loss from randomization to end of intervention
Achievement of more than 5 % weight loss [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Dietary Intervention With Shop Model - SHOPUS
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
Behavioral: Dietary intervention
Instruction to diet for 6 month
  • Experimental: New Nordic Diet
    New Nordic Diet
    Intervention: Behavioral: Dietary intervention
  • Experimental: Average Danish Diet
    Average Danish Diet
    Intervention: Behavioral: Dietary intervention
Poulsen SK, Due A, Jordy AB, Kiens B, Stark KD, Stender S, Holst C, Astrup A, Larsen TM. Health effect of the New Nordic Diet in adults with increased waist circumference: a 6-mo randomized controlled trial. Am J Clin Nutr. 2014 Jan;99(1):35-45. doi: 10.3945/ajcn.113.069393. Epub 2013 Nov 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
181
July 2012
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • abdominal obesity

Exclusion Criteria:

  • BMI > 45, previous weight change
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01195610
B 260
No
Thomas Meinert Larsen, Associate Professor, Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
University of Copenhagen
Not Provided
Principal Investigator: Thomas Meinert Larsen, PhD Department of Human Nutrition, University of Copenhagen
University of Copenhagen
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP