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Long Term Follow up After 1 Year Initial Lifestyle Intervention

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00477399
Enrollment
0
Registered
2007-05-23
Start date
2007-05-31
Completion date
2015-11-30
Last updated
2024-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Obesity, Weight loss maintenance, QOL, Life Style, Follow Up

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.

Interventions

BEHAVIORALLong term follow up after intensive lifestyle intervention

Sponsors

Sykehuset i Vestfold HF
CollaboratorOTHER
Tor-Ivar Karlsen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 67 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Weight loss03.2015

Secondary

MeasureTime frame
Health related quality of life03.2015
Anthropometrics03.2015

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026