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Local Measures to Prevent Diabetes in the Værnes Region. (VEND-RISK)

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.
ClinicalTrials.gov Identifier: NCT01135901
Recruitment Status : Active, not recruiting
First Posted : June 3, 2010
Last Update Posted : September 19, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a development project involving four different municipalities in Central Norway. The aim is to identify adults with overweight and with an increased risk of developing diabetes mellitus type 2, then to prevent the disease to develop by the means of a behaviour change programme. The programme is group based.

Condition or disease Intervention/treatment
Diabetes Mellitus Type 2 Obesity Behavioral: Behavioural change programme

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The VEND RISK-study. Preventing Diabetes Type 2 in Overweight Persons in the Værnes Region, Central-Norway.
Actual Study Start Date : April 2010
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: group programme
Group based behaviour change programme
Behavioral: Behavioural change programme
The programme consists of a introductory course, organised physical activity 2-3 times a week, meetings every 3rd month with lectures and theme nights, and organising self-help groups.

Outcome Measures

Primary Outcome Measures :
  1. Diabetes mellitus type 2 [ Time Frame: Visit 1 (baseline) till Visit 9 (5 years) ]

Eligibility Criteria

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:   No

Inclusion Criteria:

  • Living in Central Norway
  • Find Risc score > 15
  • Written, informed consent

Exclusion Criteria:

  • Severe mental disorder
  • Not being able to function in the group programme
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): NCT01135901

Vaernesregionen: Meraker, Stjørdal, Selbu, Tydal
Stjørdal, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
Principal Investigator: Bård Kulseng, PhD Norwegian University of Technology and Science
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01135901     History of Changes
Other Study ID Numbers: 2010/696-2
First Posted: June 3, 2010    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
public health
community health services

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases