Long Term Follow up After 1 Year Initial Lifestyle Intervention

Not Applicable

Withdrawn

• Conditions: Obesity
• Interventions: Behavioral: Long term follow up after intensive lifestyle intervention

• Registration Number: NCT00477399
• Lead Sponsor: Tor-Ivar Karlsen

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

200 patients will undergo a 1 year intensive lifestyle intervention.This group will be randomised into an intervention group (n=100) and a control group (n=100). The intervention group will undergo four years of further follow up in accordance with the intervention model, which means two one weeks stays each year at the Evje Clinic, telephone follow up, 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 purpose is to measure the effect of these two follow up models in regard to weight loss maintanance, Quality of Life and comorbidities.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-22
• Study First Submitted QC: 2007-05-22
• Study First Posted: 2007-05-23
• Primary Completion: 2015-03
• Study Completion: 2015-11
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Long term follow up after intensive lifestyle intervention	Receiving active follow up (two yearly 1 week stays, telephone follow up, GP-visits)

Primary Outcome Measures

Name	Time	Method
Weight loss	03.2015

Secondary Outcome Measures

Name	Time	Method
Anthropometrics	03.2015
Health related quality of life	03.2015

Trial Locations

Locations (1)

Evjeklinikken AS; 🇳🇴 Evje, Evjemoen, Norway