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Change of Lifestyle by Persons in Risk of Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00202748
Recruitment Status : Unknown
Verified December 2003 by Sorlandet Hospital HF.
Recruitment status was:  Active, not recruiting
First Posted : September 20, 2005
Last Update Posted : December 23, 2005
Sponsor:
Information provided by:
Sorlandet Hospital HF

Study Description
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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).

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Increase in activity to control weight Behavioral: Increase in activity to control weight. Phase 3

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
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Study Type : Interventional  (Clinical Trial)
Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase 3 Study of Changing of Lifestyle by Persons in Risk of Type 2 Diabetes
Study Start Date : March 2004
Study Completion Date : March 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Weigtreduction
  2. Increase in maximum oxygen uptake
  3. Change in foodintake
  4. Change in self-reported activity

Secondary Outcome Measures :
  1. Quality of life

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00202748


Locations
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Norway
Sorlandet Hospital
Kristiansand, Serviceboks 416, Norway, 4604
Sponsors and Collaborators
Sorlandet Hospital HF
Investigators
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Study Chair: Frode Gallefoss, Dr.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00202748    
Other Study ID Numbers: SSHF70201
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: December 23, 2005
Last Verified: December 2003
Keywords provided by Sorlandet Hospital HF:
metabolic syndrome
lifestyle
obesity
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases