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Dietary Intervention With Shop Model - SHOPUS

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01195610
First received: September 3, 2010
Last updated: April 25, 2012
Last verified: August 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Change in body weight (kg) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Change in body weight from randomization to end of intervention


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 200
Study Start Date: August 2010
Estimated Study Completion Date: August 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • abdominal obesity

Exclusion Criteria:

  • BMI > 45, previous weight change
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Thomas Meinert Larsen, Associate Professor, Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01195610     History of Changes
Other Study ID Numbers: B 260
Study First Received: September 3, 2010
Last Updated: April 25, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013