VEND-RISK: Local Measures to Prevent Diabetes in the Værnes Region.
Sponsor
Norwegian University of Science and Technology (Other)
Overall Status
Completed
CT.gov ID
NCT01135901
Collaborator
(none)
180
1
1
104
1.7
Study Details
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 | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
180 participants
Allocation:
N/A
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
:
Apr 1, 2010
Actual Primary Completion Date
:
Dec 1, 2018
Actual Study Completion Date
:
Dec 1, 2018
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
- Diabetes mellitus type 2 [Visit 1 (baseline) till Visit 9 (5 years)]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vaernesregionen: Meraker, Stjørdal, Selbu, Tydal | Stjørdal | Norway |
Sponsors and Collaborators
- Norwegian University of Science and Technology
Investigators
- Principal Investigator: Bård Kulseng, PhD, Norwegian University of Technology and Science
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01135901
Other Study ID Numbers:
- 2010/696-2
First Posted:
Jun 3, 2010
Last Update Posted:
Jul 20, 2020
Last Verified:
Jul 1, 2020
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
Additional relevant MeSH terms: