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NCT00202748 Clinical Trial

Change of Lifestyle by Persons in Risk of Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:
Phase 3 Study of Changing of Lifestyle by Persons in Risk of Type 2 Diabetes

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT00202748
Other study ID # SSHF70201
Secondary ID
Status Unknown status
Phase Phase 3
First received September 12, 2005
Last updated December 22, 2005
Start date March 2004
Est. completion date March 2007

Study information
Verified date December 2003
Source Sorlandet Hospital HF
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).

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".

Recruitment information / eligibility
Status Unknown status
Enrollment 220
Est. completion date March 2007
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 20 Years to 64 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Increase in activity to control weight

• Increase in activity to control weight.

Locations
Country Name City State
Norway Sorlandet Hospital Kristiansand Serviceboks 416

Sponsors (1)
Lead Sponsor Collaborator
Sorlandet Hospital HF

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Weigtreduction
Primary Increase in maximum oxygen uptake
Primary Change in foodintake
Primary Change in self-reported activity
Secondary Quality of life
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