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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Norwegian University of Science and Technology
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01135901
First received: April 26, 2010
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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 Intervention
Diabetes Mellitus Type 2
Obesity
Behavioral: Behavioural change programme

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The VEND RISK-study. Preventing Diabetes Type 2 in Overweight Persons in the Værnes Region, Central-Norway.

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Diabetes mellitus type 2 [ Time Frame: Visit 1 (baseline) till Visit 9 (5 years) ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2010
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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: NCT01135901

Locations
Norway
Vaernesregionen Recruiting
Meraker, Stjordal, Selbu, Tydal, Norway
Contact: Monica Devle       monica.devle@varnesregionen.no   
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Principal Investigator: Bård Kulseng, PhD Norwegian University of Technology and Science
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01135901     History of Changes
Other Study ID Numbers: 2010/696-2
Study First Received: April 26, 2010
Last Updated: April 16, 2014
Health Authority: Norway: Ethics Committee

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014