Back to resultsChange of Lifestyle by Persons in Risk of Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Unknown status
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Increase in activity to control weight
Increase in activity to control weight.
Sponsored by
About this trial
This is an interventional prevention trial for Type 2 Diabetes focused on measuring metabolic syndrome, lifestyle, obesity
Eligibility Criteria
Inclusion Criteria: Diabetes risk score above 9 points. Exclusion Criteria: Persons with diabetes, serious heart disease, cancer or psychiatric disorder. They have to speak and understand Norwegian language.
Sites / Locations
- Sorlandet Hospital
Outcomes
Primary Outcome Measures
Weigtreduction
Increase in maximum oxygen uptake
Change in foodintake
Change in self-reported activity
Secondary Outcome Measures
Quality of life
Full Information
NCT ID
NCT00202748
First Posted
September 12, 2005
Last Updated
December 22, 2005
Sponsor
Sorlandet Hospital HF
1. Study Identification
Unique Protocol Identification Number
NCT00202748
Brief Title
Change of Lifestyle by Persons in Risk of Type 2 Diabetes
Official Title
Phase 3 Study of Changing of Lifestyle by Persons in Risk of Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2003
Overall Recruitment Status
Unknown status
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sorlandet Hospital HF
4. Oversight
5. Study Description
Brief 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).
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".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
metabolic syndrome, lifestyle, obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Increase in activity to control weight
Intervention Type
Behavioral
Intervention Name(s)
Increase in activity to control weight.
Primary Outcome Measure Information:
Title
Weigtreduction
Title
Increase in maximum oxygen uptake
Title
Change in foodintake
Title
Change in self-reported activity
Secondary Outcome Measure Information:
Title
Quality of life
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diabetes risk score above 9 points.
Exclusion Criteria: Persons with diabetes, serious heart disease, cancer or psychiatric disorder. They have to speak and understand Norwegian language.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frode Gallefoss, Dr.
Official's Role
Study Chair
Facility Information:
Facility Name
Sorlandet Hospital
City
Kristiansand
State/Province
Serviceboks 416
ZIP/Postal Code
4604
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
25682903
Citation
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.
Results Reference
derived
PubMed Identifier
24789668
Citation
Nilsen 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.
Results Reference
derived
PubMed Identifier
22117618
Citation
Nilsen 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.
Results Reference
derived
Learn more about this trial
Change of Lifestyle by Persons in Risk of Type 2 Diabetes
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