Lifestyle Intervention in Obesity, Effect on Diabetes

This study is currently recruiting participants.

Verified by Evjeklinikken, May 2007

First Received: April 25, 2007 Last Updated: May 22, 2007 History of Changes

Sponsored by:	Evjeklinikken
Information provided by:	Evjeklinikken
ClinicalTrials.gov Identifier:	NCT00466362

Purpose

There are evidence from numerous studies on effect of lifestyle intervention in morbidly obese patients with type 2 diabetes. This study examines the effect of the "Evje-model" on type 2 diabetes.

The "Evje-model" is a combined 12 months model, consisting of repeated stays in a specialist centre, telephone follow-up at home, home groups, self monitoring and close contact with the patients’ local physician.

Condition	Intervention
Type 2 Diabetes	Behavioral: The Evje Model

MedlinePlus related topics: Diabetes Obesity

U.S. FDA Resources

Study Type:	Observational
Study Design:	Psychosocial, Longitudinal, Defined Population, Prospective Study
Official Title:	One Year Observational Study on Effects of Lifestyle Intervention in Morbidly Obese Persons With Type 2 Diabetes.

Further study details as provided by Evjeklinikken:

Estimated Enrollment:	50
Study Start Date:	April 2007
Estimated Study Completion Date:	December 2008

Detailed Description:

There will be done QOL-measures, blood- and urine analysis, weight, waist- and hip measurement, blood pressure and VO2-max measurement at baseline, after 6 months and after 12 months.

Eligibility

Ages Eligible for Study:	18 Years to 67 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All patients with BMI > 35 with diagnosed type 2 diabetes
Referred to Lifestyle Intervention from a public hospital

Exclusion Criteria:

Pregnancy
Active major psychiatric disease(s)
Active and serious eating disorder
Drug- and/or alcohol dependency

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466362

Contacts

Contact: Tor I Karlsen, RN	0047 900 60 536	tik@evjeklinikken.no
Contact: Arne Quist-Paulsen, MD	0047 90060536	arneqp@online.no

Locations

Norway, Evjemoen
Evjeklinikken AS	Recruiting
Evje og Hornnes, Evjemoen, Norway, 4735
Contact: Tor I Karlsen, RN, Cand. Polit. 0047 900 60 536 tik@evjeklinikken.no

Sponsors and Collaborators

Evjeklinikken

Investigators

Principal Investigator:

Tom B Schulz, Dr. Med.

Evjeklinikken

More Information

No publications provided

Study ID Numbers:	EK0702
Study First Received:	April 25, 2007
Last Updated:	May 22, 2007
ClinicalTrials.gov Identifier:	NCT00466362 History of Changes
Health Authority:	Norway: The National Committees for Research Ethics in Norway

Keywords provided by Evjeklinikken:

Obesity
Diabetes
Weight
Lifestyle
Follow up

Study placed in the following topic categories:

Body Weight
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