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Change of Lifestyle by Persons in Risk of Type 2 Diabetes

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2003 by Sorlandet Hospital HF.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00202748
First Posted: September 20, 2005
Last Update Posted: December 23, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sorlandet Hospital HF
  Purpose
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 Intervention Phase
Type 2 Diabetes Behavioral: Increase in activity to control weight Behavioral: Increase in activity to control weight. Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sorlandet Hospital HF:

Primary Outcome Measures:
  • Weigtreduction
  • Increase in maximum oxygen uptake
  • Change in foodintake
  • Change in self-reported activity

Secondary Outcome Measures:
  • Quality of life

Estimated Enrollment: 220
Study Start Date: March 2004
Estimated Study Completion Date: March 2007
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".

  Eligibility

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

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
Norway
Sorlandet Hospital
Kristiansand, Serviceboks 416, Norway, 4604
Sponsors and Collaborators
Sorlandet Hospital HF
Investigators
Study Chair: Frode Gallefoss, Dr.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00202748     History of Changes
Other Study ID Numbers: SSHF70201
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: December 23, 2005
Last Verified: December 2003

Keywords provided by Sorlandet Hospital HF:
metabolic syndrome
lifestyle
obesity

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases