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Change of Lifestyle by Persons in Risk of Type 2 Diabetes
This study is ongoing, but not recruiting participants.
First Received: September 12, 2005   Last Updated: December 22, 2005   History of Changes
Sponsored by: Sorlandet Hospital HF
Information provided by: Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT00202748
  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 III

MedlinePlus related topics: Diabetes
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Phase 3 Study of Changing of Lifestyle by Persons in Risk of Type 2 Diabetes

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

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00202748

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

No publications provided

Study ID Numbers: SSHF70201
Study First Received: September 12, 2005
Last Updated: December 22, 2005
ClinicalTrials.gov Identifier: NCT00202748     History of Changes
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Sorlandet Hospital HF:
metabolic syndrome
lifestyle
obesity

Study placed in the following topic categories:
Obesity
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

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

ClinicalTrials.gov processed this record on May 07, 2009