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Lifestyle Intervention in Morbidly Obese Patients

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ClinicalTrials.gov Identifier: NCT00464984
Recruitment Status : Active, not recruiting
First Posted : April 24, 2007
Last Update Posted : April 19, 2018
Sponsor:
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Jøran Hjelmesæth, 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

Condition or disease Intervention/treatment Phase
Morbid Obesity Behavioral: Lifestyle intervention Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lifestyle Intervention in Morbidly Obese Patients
Study Start Date : August 2006
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : December 2022

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U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 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.
Behavioral: Lifestyle intervention
Intensive lifestyle intervention at a rehabilitation centre 3 times a week the first 3 months of study
Active Comparator: MLI
Moderate lifestyle intervention at a secondary care outpatient center. Treatment included moderate changes in dietary habits (calori restriction) and physical activity.
Behavioral: Lifestyle intervention
Intensive lifestyle intervention at a rehabilitation centre 3 times a week the first 3 months of study



Primary Outcome Measures :
  1. Weight loss, physical fitness and quality of life [ Time Frame: 1 and 4 years ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00464984


Locations
Norway
Spesialsykehuset for Rehabilitering i Stavern
Stavern, Vestfold, Norway
Sponsors and Collaborators
The Hospital of Vestfold
Oslo University Hospital
Investigators
Study Chair: Jøran Hjelmesæth, MD, PhD Morbid Obesity Center, Hospital of Vestfold, Boks 2168, NORWAY

Responsible Party: Jøran Hjelmesæth, Head of Morbid Obesity Centre, The Hospital of Vestfold
ClinicalTrials.gov Identifier: NCT00464984     History of Changes
Other Study ID Numbers: S-05175.1
First Posted: April 24, 2007    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018

Keywords provided by Jøran Hjelmesæth, The Hospital of Vestfold:
Weight loss
Physical fitness
Quality of life

Additional relevant MeSH terms:
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms