Lifestyle Intervention in Morbidly Obese Patients

The Hospital of Vestfold

Status: Completed

Conditions: Morbid Obesity

Treatments: Behavioral: Lifestyle intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT00464984

S-05175.1

Details and patient eligibility

About

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

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

ILI-group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Lifestyle intervention

MLI

Active Comparator group

Description:

Moderate lifestyle intervention at a secondary care outpatient center. Treatment included moderate changes in dietary habits (calori restriction) and physical activity.

Treatment:

Behavioral: Lifestyle intervention