Long Term Follow up After 1 Year Initial Lifestyle Intervention

Tor-Ivar Karlsen

Status: Withdrawn

Conditions: Obesity

Treatments: Behavioral: Long term follow up after intensive lifestyle intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT00477399

EK0701

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 67 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Intervention

Other group

Description:

Receiving active follow up (two yearly 1 week stays, telephone follow up, GP-visits)

Treatment:

Behavioral: Long term follow up after intensive lifestyle intervention

Control

No Intervention group

Description:

Control group