Lifestyle Intervention in Morbidly Obese Patients

Not Applicable

Completed

• Conditions: Morbid Obesity
• Interventions: Behavioral: Lifestyle intervention

• Registration Number: NCT00464984
• Lead Sponsor: The Hospital of Vestfold

Brief Summary

The long term effects of organized lifestyle intervention on weight loss, physical fitness and quality of life in morbidly obese patients have not been extensively studied. The objective of this study is to investigate whether an intensive lifestyle intervention program in a tertiary care clinic (Spesialsykehuset for Rehabilitating) is superior to lifestyle intervention in a primary care setting with respect to long term (4-years) changes in weight loss, physical fitness and quality of life

Detailed Description

Due to limited recruitment from GP, the study design has been changed into an observational long term study following the participants in the intensive lifestyle intervention group

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2007-04-23
• Study First Submitted QC: 2007-04-23
• Study First Posted: 2007-04-24
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Morbidly obese patients not planned for bariatric surgery

Exclusion Criteria

• Participation in other weight loss programs during the last 12 mths
• Serious psychiatric conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ILI-group	Lifestyle intervention	Intensive lifestyle intervention at a tertiary care rehabilitation center. Treatment included changes in both dietary habits (calori restriction) and physical activity with particularly high intensity the first 3 months.
MLI	Lifestyle intervention	Moderate lifestyle intervention at a secondary care outpatient center. Treatment included moderate changes in dietary habits (calori restriction) and physical activity.

Primary Outcome Measures

Name	Time	Method
Weight loss, physical fitness and quality of life	1 and 4 years

Trial Locations

Locations (1)

Spesialsykehuset for Rehabilitering i Stavern; 🇳🇴 Stavern, Vestfold, Norway