Long Term Follow up After 1 Year Initial Lifestyle Intervention
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|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
|First Submitted Date ICMJE||May 22, 2007|
|First Posted Date ICMJE||May 23, 2007|
|Last Update Posted Date||May 23, 2007|
|Study Start Date ICMJE||May 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Long Term Follow up After 1 Year Initial Lifestyle Intervention|
|Official Title ICMJE||Effect of Four Years Intensive- Versus Regular Follow up, After a One Year Weight Loss Period, in Patients With Morbid Obesity.|
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.
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 ICMJE||Interventional|
|Study Phase||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Intervention ICMJE||Behavioral: The Evje Model|
|Study Arms||Not Provided|
|Publications *||Karlsen TI, Søhagen M, Hjelmesæth J. Predictors of weight loss after an intensive lifestyle intervention program in obese patients: a 1-year prospective cohort study. Health Qual Life Outcomes. 2013 Oct 3;11:165. doi: 10.1186/1477-7525-11-165.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE
|Original Estimated Enrollment ICMJE||Same as current|
|Estimated Study Completion Date||May 2012|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 67 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Norway|
|Removed Location Countries|
|NCT Number ICMJE||NCT00477399|
|Other Study ID Numbers ICMJE||EK0701|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Evjeklinikken|
|Collaborators ICMJE||Sykehuset i Vestfold HF|
|Verification Date||May 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP