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.|
|ClinicalTrials.gov 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
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|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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 ClinicalTrials.gov identifier (NCT number): NCT00477399
|Contact: Tor I Karlsen, RN||0047 900 60 email@example.com|
|Evje og Hornnes, Evjemoen, Norway, 4735|
|Contact: Tor I Karlsen, RN 0047 900 60 536 firstname.lastname@example.org|
|Study Chair:||Joran Hjelmesath, Dr. Med.||Sykehuset i Vestfold HF|