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| Sponsors and Collaborators: |
Evjeklinikken Senter for Sykelig Overvekt, Sykehuset i Vestfold HF |
| Information provided by: | Evjeklinikken |
| ClinicalTrials.gov Identifier: | NCT00477399 |
Purpose
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 | Intervention |
|
Obesity |
Behavioral: The Evje Model |
| MedlinePlus related topics: | Obesity Weight Control |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Effect of Four Years Intensive- Versus Regular Follow up, After a One Year Weight Loss Period, in Patients With Morbid Obesity. |
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | May 2012 |
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.
Eligibility
| Ages Eligible for Study: | 18 Years to 67 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Tor I Karlsen, RN | 0047 900 60 536 | tik@evjeklinikken.no |
| Norway, Evjemoen | |||||
| Evjeklinikken AS | Recruiting | ||||
| Evje og Hornnes, Evjemoen, Norway, 4735 | |||||
| Contact: Tor I Karlsen, RN 0047 900 60 536 tik@evjeklinikken.no | |||||
| Evjeklinikken |
| Senter for Sykelig Overvekt, Sykehuset i Vestfold HF |
| Study Chair: | Joran Hjelmesath, Dr. Med. | Senter for Sykelig Overvekt, Sykehuset i Vestfold HF |
More Information
Home page of Evjeklinikken
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| Study ID Numbers: | EK0701 |
| First Received: | May 22, 2007 |
| Last Updated: | May 22, 2007 |
| ClinicalTrials.gov Identifier: | NCT00477399 |
| Health Authority: | Norway: The National Committees for Research Ethics in Norway |
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