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

Primary Purpose

Diabetes Mellitus Type 2, Obesity

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Behavioural change programme
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus Type 2 focused on measuring prevention, public health, community health services, Norway

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vaernesregionen: Meraker, Stjørdal, Selbu, Tydal

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

group programme

Arm Description

Group based behaviour change programme

Outcomes

Primary Outcome Measures

Diabetes mellitus type 2

Secondary Outcome Measures

Full Information

First Posted
April 26, 2010
Last Updated
July 16, 2020
Sponsor
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT01135901
Brief Title
Local Measures to Prevent Diabetes in the Værnes Region.
Acronym
VEND-RISK
Official Title
The VEND RISK-study. Preventing Diabetes Type 2 in Overweight Persons in the Værnes Region, Central-Norway.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 2010 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2, Obesity
Keywords
prevention, public health, community health services, Norway

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group programme
Arm Type
Experimental
Arm Description
Group based behaviour change programme
Intervention Type
Behavioral
Intervention Name(s)
Behavioural change programme
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diabetes mellitus type 2
Time Frame
Visit 1 (baseline) till Visit 9 (5 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bård Kulseng, PhD
Organizational Affiliation
Norwegian University of Technology and Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vaernesregionen: Meraker, Stjørdal, Selbu, Tydal
City
Stjørdal
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
28878932
Citation
Folling 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-RISK Study). BMJ Open Diabetes Res Care. 2017 Jul 31;5(1):e000368. doi: 10.1136/bmjdrc-2016-000368. eCollection 2017.
Results Reference
result
PubMed Identifier
35264353
Citation
Folling IS, Klockner C, Devle MT, Kulseng B. Preventing type 2 diabetes, overweight and obesity in the Norwegian primary healthcare: a longitudinal design with 60 months follow-up results and a cross-sectional design with comparison of dropouts versus completers. BMJ Open. 2022 Mar 9;12(3):e054841. doi: 10.1136/bmjopen-2021-054841.
Results Reference
derived
PubMed Identifier
27557801
Citation
Folling IS, Solbjor M, Midthjell K, Kulseng B, Helvik AS. Exploring lifestyle and risk in preventing type 2 diabetes-a nested qualitative study of older participants in a lifestyle intervention program (VEND-RISK). BMC Public Health. 2016 Aug 25;16(1):876. doi: 10.1186/s12889-016-3559-y.
Results Reference
derived

Learn more about this trial

Local Measures to Prevent Diabetes in the Værnes Region.

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