Long Term Follow up After 1 Year Initial Lifestyle Intervention
Primary Purpose
Obesity
Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
The Evje Model
Sponsored by

About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Weight loss maintenance, QOL, Life Style, Follow Up
Eligibility Criteria
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
Sites / Locations
- Evjeklinikken ASRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00477399
First Posted
May 22, 2007
Last Updated
May 22, 2007
Sponsor
Evjeklinikken
Collaborators
Sykehuset i Vestfold HF
1. Study Identification
Unique Protocol Identification Number
NCT00477399
Brief Title
Long Term Follow up After 1 Year Initial Lifestyle Intervention
Official Title
Effect of Four Years Intensive- Versus Regular Follow up, After a One Year Weight Loss Period, in Patients With Morbid Obesity.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Unknown status
Study Start Date
May 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Evjeklinikken
Collaborators
Sykehuset i Vestfold HF
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Weight loss maintenance, QOL, Life Style, Follow Up
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
The Evje Model
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tor I Karlsen, RN
Phone
0047 900 60 536
Email
tik@evjeklinikken.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joran Hjelmesath, Dr. Med.
Organizational Affiliation
Sykehuset i Vestfold HF
Official's Role
Study Chair
Facility Information:
Facility Name
Evjeklinikken AS
City
Evje og Hornnes
State/Province
Evjemoen
ZIP/Postal Code
4735
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tor I Karlsen, RN
Phone
0047 900 60 536
Email
tik@evjeklinikken.no
12. IPD Sharing Statement
Citations:
PubMed Identifier
24090083
Citation
Karlsen TI, Sohagen M, Hjelmesaeth 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.
Results Reference
derived
Links:
URL
http://www.evjeklinikken.no
Description
Home page of Evjeklinikken
Learn more about this trial
Long Term Follow up After 1 Year Initial Lifestyle Intervention
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