Long Term Follow up After 1 Year Initial Lifestyle Intervention

Obesity Clinical Trial

Official title:

Effect of Four Years Intensive- Versus Regular Follow up, After a One Year Weight Loss Period, in Patients With Morbid Obesity.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00477399
• Other study ID #: EK0701
• Status: Recruiting
• Phase: N/A
• First received: May 22, 2007
• Last updated: May 22, 2007
• Start date: May 2007
• Est. completion date: May 2012

Study information

• Verified date: May 2007
• Source: Evjeklinikken
• Contact: Tor I Karlsen, RN
• Phone: 0047 900 60 536
• Email: tik[@]evjeklinikken.no
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 67 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• The Evje Model

Locations

Country	Name	City	State
Norway	Evjeklinikken AS	Evje og Hornnes	Evjemoen

Sponsors (2)

Lead Sponsor	Collaborator
Evjeklinikken	Sykehuset i Vestfold HF

Country where clinical trial is conducted

Norway, 

External Links

•   Home page of Evjeklinikken