Change of Lifestyle by Persons in Risk of Type 2 Diabetes

• Sponsor: Sorlandet Hospital HF (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00202748
• Collaborator: (none)
• Enrollment: 220
• Location: 1
• Duration (Months): 36
• Patients Per Site Per Month: 6.1

Study Details

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).

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

• Study Type: Interventional
• 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: Mar 1, 2004
• Study Completion Date: Mar 1, 2007

Outcome Measures

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

Criteria

• Ages Eligible for Study: 20 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Sorlandet Hospital	Kristiansand	Serviceboks 416	Norway	4604

Sponsors and Collaborators

• Sorlandet Hospital HF

Investigators

• Study Chair: Frode Gallefoss, Dr.,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00202748
• Other Study ID Numbers: SSHF70201
• First Posted: Sep 20, 2005
• Last Update Posted: Dec 23, 2005
• Last Verified: Dec 1, 2003

• Keywords provided by , ,: metabolic syndrome; lifestyle; obesity
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Dec 23, 2005