Lifestyle Intervention in Morbidly Obese Patients

NCT ID: NCT00464984

Last Updated: 2021-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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

Conditions

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Morbid Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ILI-group

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.

Group Type ACTIVE_COMPARATOR

Lifestyle intervention

Intervention Type BEHAVIORAL

Intensive lifestyle intervention at a rehabilitation centre 3 times a week the first 3 months of study

MLI

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

Group Type ACTIVE_COMPARATOR

Lifestyle intervention

Intervention Type BEHAVIORAL

Intensive lifestyle intervention at a rehabilitation centre 3 times a week the first 3 months of study

Interventions

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Lifestyle intervention

Intensive lifestyle intervention at a rehabilitation centre 3 times a week the first 3 months of study

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role collaborator

The Hospital of Vestfold

OTHER

Sponsor Role lead

Responsible Party

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Jøran Hjelmesæth

Head of Morbid Obesity Centre

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jøran Hjelmesæth, MD, PhD

Role: STUDY_CHAIR

Morbid Obesity Center, Hospital of Vestfold, Boks 2168, NORWAY

Locations

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Spesialsykehuset for Rehabilitering i Stavern

Stavern, Vestfold, Norway

Site Status

Countries

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Norway

Other Identifiers

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S-05175.1

Identifier Type: -

Identifier Source: org_study_id

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