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Long Term Follow up After 1 Year Initial Lifestyle Intervention

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by Evjeklinikken.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Senter for Sykelig Overvekt, Sykehuset i Vestfold HF
Information provided by:
Evjeklinikken
ClinicalTrials.gov Identifier:
NCT00477399
First received: May 22, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Evjeklinikken:

Estimated Enrollment: 100
Study Start Date: May 2007
Estimated Study Completion Date: May 2012
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.

  Eligibility

Ages Eligible for Study:   18 Years to 67 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00477399

Contacts
Contact: Tor I Karlsen, RN 0047 900 60 536 tik@evjeklinikken.no

Locations
Norway
Evjeklinikken AS Recruiting
Evje og Hornnes, Evjemoen, Norway, 4735
Contact: Tor I Karlsen, RN     0047 900 60 536     tik@evjeklinikken.no    
Sponsors and Collaborators
Evjeklinikken
Senter for Sykelig Overvekt, Sykehuset i Vestfold HF
Investigators
Study Chair: Joran Hjelmesath, Dr. Med. Senter for Sykelig Overvekt, Sykehuset i Vestfold HF
  More Information

Additional Information:
Home page of Evjeklinikken  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00477399     History of Changes
Other Study ID Numbers: EK0701
Study First Received: May 22, 2007
Last Updated: May 22, 2007
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

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

ClinicalTrials.gov processed this record on May 16, 2013