NCT01135901

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 3, 2010

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 20, 2020

Status Verified

July 1, 2020

Enrollment Period

8.7 years

First QC Date

April 26, 2010

Last Update Submit

July 16, 2020

Conditions

Keywords

preventionpublic healthcommunity health servicesNorway

Outcome Measures

Primary Outcomes (1)

  • Diabetes mellitus type 2

    Visit 1 (baseline) till Visit 9 (5 years)

Study Arms (1)

group programme

EXPERIMENTAL

Group based behaviour change programme

Behavioral: Behavioural change programme

Interventions

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.

group programme

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vaernesregionen: Meraker, Stjørdal, Selbu, Tydal

Stjørdal, Norway

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bård Kulseng, PhD

    Norwegian University of Technology and Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2010

First Posted

June 3, 2010

Study Start

April 1, 2010

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

July 20, 2020

Record last verified: 2020-07

Locations