Type 2 DiabetesPhase 3NCT00202748
Change of Lifestyle by Persons in Risk of Type 2 Diabetes
A Phase 3 study of Type 2 Diabetes, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
We know that changing lifestyle can prevent type 2 diabetes. The challenge is how to help people changing their lifestyle. We have people in 2 groups: half of them is meeting in grops of 10 persons (interventiongroup), the other ones are just visiting their doctor (controlgroup). Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Type 2 Diabetes
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 220 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2004to Mar 2007
- Phase
- Phase 3
- 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 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Exclusion Criteria: Persons with diabetes, serious heart disease, cancer or psychiatric disorder. They have to speak and understand Norwegian language.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3 Study of Changing of Lifestyle by Persons in Risk of Type 2 Diabetes
We know that changing lifestyle can prevent type 2 diabetes. The challenge is how to help people changing their lifestyle. We have people in 2 groups: half of them is meeting in grops of 10 persons (interventiongroup), the other ones are just visiting their doctor (controlgroup).
Read the detailed description
The intervention group are meeting different healt proffesionals (nurse, doctor, eksperts on nutrition,experts on activity and experts on how to change. They have 7 meetings in groups of 10 persons over 3 months. The controlgroup are just meeting their own doctor or the doctor in the hospital 2 times a year.
We tell all that small changes are making big differenses (in weight and the chanse of getting ill). Everyone is told that lack of aktivity is the main reason to obesity. Lack of activity also influense in whar you eat. herefore is activity in the "center".
- Conditions
- Type 2 Diabetes
- Being tested
- Increase in activity to control weight, Increase in activity to control weight.
- Keywords
- metabolic syndrome, lifestyle, obesity
- Medical subject headings
- Diabetes Mellitus, Type 2, Metabolic Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increase in activity to control weightBehavioural
Increase in activity to control weight.Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Weigtreduction
Increase in maximum oxygen uptake
Change in foodintake
Change in self-reported activity
Secondary outcomes (1)
Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMar 2004
- Study completionMar 2007
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 Type 2 DiabetesStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Investigators
- Frode Gallefoss, Dr., Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202748
- Sponsor's protocol ID
- SSHF70201
- Status last verified
- Dec 2003
- First submitted
- 12 Sep 2005
- Last updated
- 23 Dec 2005
- Results posted
- No
Publications
Nilsen V, Bakke PS, Rohde G, Gallefoss F. Is sense of coherence a predictor of lifestyle changes in subjects at risk for type 2 diabetes? Public Health. 2015 Feb;129(2):155-61. doi: 10.1016/j.puhe.2014.12.014. Epub 2015 Feb 13.
PubMed 25682903Nilsen V, Bakke PS, Rohde G, Gallefoss F. Predictors of health-related quality of life changes after lifestyle intervention in persons at risk of type 2 diabetes mellitus. Qual Life Res. 2014 Nov;23(9):2585-93. doi: 10.1007/s11136-014-0702-z. Epub 2014 May 1.
PubMed 24789668Nilsen V, Bakke PS, Gallefoss F. Effects of lifestyle intervention in persons at risk for type 2 diabetes mellitus - results from a randomised, controlled trial. BMC Public Health. 2011 Nov 25;11:893. doi: 10.1186/1471-2458-11-893.
PubMed 22117618
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Changing of Lifestyle by Persons in Risk of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00202748
- Acronym / sponsor ID
- SSHF70201
- Conditions
- Type 2 Diabetes
- Keywords
- metabolic syndrome, lifestyle, obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants
- Lead sponsor
- Sorlandet Hospital HFOther government
- Study start
- Mar 2004
- Study completion
- Mar 2007
- First posted
- 20 Sep 2005 (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.
We know that changing lifestyle can prevent type 2 diabetes. The challenge is how to help people changing their lifestyle. We have people in 2 groups: half of them is meeting in grops of 10 persons (interventiongroup), the other ones are just visiting their doctor (controlgroup).
Detailed description
The intervention group are meeting different healt proffesionals (nurse, doctor, eksperts on nutrition,experts on activity and experts on how to change. They have 7 meetings in groups of 10 persons over 3 months. The controlgroup are just meeting their own doctor or the doctor in the hospital 2 times a year.
We tell all that small changes are making big differenses (in weight and the chanse of getting ill). Everyone is told that lack of aktivity is the main reason to obesity. Lack of activity also influense in whar you eat. herefore is activity in the "center".
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Exclusion Criteria: Persons with diabetes, serious heart disease, cancer or psychiatric disorder. They have to speak and understand Norwegian language.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Increase in activity to control weight | Behavioural | – |
| Increase in activity to control weight. | Behavioural | – |
Primary outcome
Weigtreduction
Increase in maximum oxygen uptake
Change in foodintake
Change in self-reported activity
1 secondary outcome
Quality of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2005.
- Derived from this study: PubMed 25682903Nilsen V, Bakke PS, Rohde G, Gallefoss F. Is sense of coherence a predictor of lifestyle changes in subjects at risk for type 2 diabetes? Public Health. 2015 Feb;129(2):155-61. doi: 10.1016/j.puhe.2014.12.014. Epub 2015 Feb 13.
- Derived from this study: PubMed 24789668Nilsen V, Bakke PS, Rohde G, Gallefoss F. Predictors of health-related quality of life changes after lifestyle intervention in persons at risk of type 2 diabetes mellitus. Qual Life Res. 2014 Nov;23(9):2585-93. doi: 10.1007/s11136-014-0702-z. Epub 2014 May 1.
- Derived from this study: PubMed 22117618Nilsen V, Bakke PS, Gallefoss F. Effects of lifestyle intervention in persons at risk for type 2 diabetes mellitus - results from a randomised, controlled trial. BMC Public Health. 2011 Nov 25;11:893. doi: 10.1186/1471-2458-11-893.
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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.
Frode Gallefoss, Dr. study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Type 2 Diabetes, run by Sorlandet Hospital HF 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 1 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 23 Dec 2005. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Weigtreduction. The study lists 4 primary outcomes in all. 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 NCT00202748, 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 23 Dec 2005.