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Change of Lifestyle by Persons in Risk of Type 2 Diabetes

NCT ID: NCT00202748

Last Updated: 2005-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2007-03-31

Brief Summary

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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).

Detailed Description

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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".

Conditions

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Type 2 Diabetes

Keywords

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metabolic syndrome lifestyle obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Increase in activity to control weight

Intervention Type BEHAVIORAL

Increase in activity to control weight.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sorlandet Hospital HF

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Frode Gallefoss, Dr.

Role: STUDY_CHAIR

Locations

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Sorlandet Hospital

Kristiansand, Serviceboks 416, Norway

Site Status

Countries

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Norway

References

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Nilsen V, Bakke PS, Rohde G, Gallefoss F. Is sense of coherence a predictor of lifestyle changes in subjects at risk for type 2 diabetes? Public Health. 2015 Feb;129(2):155-61. doi: 10.1016/j.puhe.2014.12.014. Epub 2015 Feb 13.

Reference Type DERIVED
PMID: 25682903 (View on PubMed)

Nilsen V, Bakke PS, Rohde G, Gallefoss F. Predictors of health-related quality of life changes after lifestyle intervention in persons at risk of type 2 diabetes mellitus. Qual Life Res. 2014 Nov;23(9):2585-93. doi: 10.1007/s11136-014-0702-z. Epub 2014 May 1.

Reference Type DERIVED
PMID: 24789668 (View on PubMed)

Nilsen V, Bakke PS, Gallefoss F. Effects of lifestyle intervention in persons at risk for type 2 diabetes mellitus - results from a randomised, controlled trial. BMC Public Health. 2011 Nov 25;11:893. doi: 10.1186/1471-2458-11-893.

Reference Type DERIVED
PMID: 22117618 (View on PubMed)

Other Identifiers

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SSHF70201

Identifier Type: -

Identifier Source: org_study_id