Long Term Follow up After 1 Year Initial Lifestyle Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00477399
Recruitment Status : Unknown
Verified May 2007 by Evjeklinikken.
Recruitment status was:  Recruiting
First Posted : May 23, 2007
Last Update Posted : May 23, 2007
Sykehuset i Vestfold HF
Information provided by:

Brief Summary:

The effect of non-surgical methods for obesity treatment are not fully documented. This study focus on the long term effect of an intensiv follow up (the "Evje Model") compared to a regular follow up.

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

Condition or disease Intervention/treatment Phase
Obesity Behavioral: The Evje Model Not Applicable

Detailed Description:

Eighty patients will undergo an intensive lifestyle intervention following the "Evje Model". This group will be randomised into an intervention group and a control group. The intervention group will undergo four years of further follow up in accordance with the Evje Model, which means two one weeks stays each year at the Evje Clinic, telephone follow up, home groups, self monitoring and collaboration with the patients' local physician.

The control group will be followed up by the patients local physician and a yearly control at the Center for Morbid Obesity at Vestfold Hospital (Sykehuset i Vestfold HF). The control group will have a yearly week end at Evjeklinikken for testing.

The purpose is to measure the effect of these two follow up models in regard to weight loss maintanance, Quality of Life and comorbidities.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Four Years Intensive- Versus Regular Follow up, After a One Year Weight Loss Period, in Patients With Morbid Obesity.
Study Start Date : May 2007
Estimated Study Completion Date : May 2012

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients, referred from Public Hospitals, with morbid obesity that have undergone one year intensive life style intervention in accordance with the Evje Model.

Exclusion Criteria:

  • Pregnancy, major and active psychiatric disease, active and serious eating disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00477399

Contact: Tor I Karlsen, RN 0047 900 60 536

Evjeklinikken AS Recruiting
Evje og Hornnes, Evjemoen, Norway, 4735
Contact: Tor I Karlsen, RN    0047 900 60 536   
Sponsors and Collaborators
Sykehuset i Vestfold HF
Study Chair: Joran Hjelmesath, Dr. Med. Sykehuset i Vestfold HF

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00477399     History of Changes
Other Study ID Numbers: EK0701
First Posted: May 23, 2007    Key Record Dates
Last Update Posted: May 23, 2007
Last Verified: May 2007

Keywords provided by Evjeklinikken:
Weight loss maintenance
Life Style
Follow Up

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms