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: July 29, 2014
Last verified: August 2011
  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:


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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Publications:
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: July 29, 2014
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 August 26, 2014