Diabetes Mellitus Type 2VEND-RISKNCT01135901
Local Measures to Prevent Diabetes in the Værnes Region.
A study testing Behavioural change programme in people with Diabetes Mellitus Type 2 and Obesity, run by Norwegian University of Science and Technology at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus Type 2, Obesity
- What is being tested?
- Behavioural change programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2010to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Living in Central Norway
- Find Risc score > 15
- Written, informed consent
Who cannot join
- Severe mental disorder
- Not being able to function in the group programme
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The VEND RISK-study. Preventing Diabetes Type 2 in Overweight Persons in the Værnes Region, Central-Norway.
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.
- Conditions
- Diabetes Mellitus Type 2, Obesity
- Being tested
- Behavioural change programme
- Keywords
- prevention, public health, community health services, Norway
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioural change programmeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| group programme | Experimental | Group based behaviour change programme Receives: Behavioral: Behavioural change programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes mellitus type 2
Measured: Visit 1 (baseline) till Visit 9 (5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startApr 2010
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bård Kulseng, PhD, Principal investigator, Norwegian University of Technology and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135901
- Sponsor's protocol ID
- 2010/696-2
- Acronym
- VEND-RISK
- Status last verified
- Jul 2020
- First submitted
- 26 Apr 2010
- Last updated
- 20 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28878932Folling 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.
PubMed 35264353Folling 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.
PubMed 27557801
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The VEND RISK-study. Preventing Diabetes Type 2 in Overweight Persons in the Værnes Region, Central-Norway.
- ClinicalTrials.gov ID
- NCT01135901
- Acronym / sponsor ID
- VEND-RISK / 2010/696-2
- Conditions
- Diabetes Mellitus Type 2, Obesity
- Keywords
- prevention, public health, community health services, Norway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Apr 2010 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 3 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group programme | Experimental | Behavioral: Behavioural change programmeGroup based behaviour change programme |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Living in Central Norway
- Find Risc score > 15
- Written, informed consent
Key exclusion criteria (2 listed)
- Severe mental disorder
- Not being able to function in the group programme
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioural change programmeThe 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. | Behavioural | group programme |
Primary outcome
Diabetes mellitus type 2
Time frame: Visit 1 (baseline) till Visit 9 (5 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
- Results publication: PubMed 28878932Folling 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.
- Derived from this study: PubMed 35264353Folling 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.
- Derived from this study: PubMed 27557801Folling 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bård Kulseng, PhD principal investigator
Norwegian University of Technology and Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioural change programme in people with Diabetes Mellitus Type 2 and Obesity, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes mellitus type 2 (time frame: Visit 1 (baseline) till Visit 9 (5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01135901, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2020.