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NCT01135901 Clinical Trial

Local Measures to Prevent Diabetes in the Værnes Region.

Obesity Clinical Trial

— VEND-RISK  

Official title:
The VEND RISK-study. Preventing Diabetes Type 2 in Overweight Persons in the Værnes Region, Central-Norway.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01135901
Other study ID # 2010/696-2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2010
Est. completion date December 1, 2018

Study information
Verified date July 2020
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date December 1, 2018
Est. primary completion date December 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Norway Vaernesregionen: Meraker, Stjørdal, Selbu, Tydal Stjørdal

Sponsors (1)
Lead Sponsor Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Følling IS, Kulseng B, Midthjell K, Rangul V, Helvik AS. Individuals at high risk for type 2 diabetes invited to a lifestyle program: characteristics of participants versus non-participants (the HUNT Study) and 24-month follow-up of participants (the VEND — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Diabetes mellitus type 2 Visit 1 (baseline) till Visit 9 (5 years)
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