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Lifestyle Intervention in Morbidly Obese Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00464984
Recruitment Status : Active, not recruiting
First Posted : April 24, 2007
Last Update Posted : March 30, 2020
Sponsor:
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Jøran Hjelmesæth, The Hospital of Vestfold

Tracking Information
First Submitted Date  ICMJE April 23, 2007
First Posted Date  ICMJE April 24, 2007
Last Update Posted Date March 30, 2020
Study Start Date  ICMJE August 2006
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2011)		 Weight loss, physical fitness and quality of life [ Time Frame: 1 and 4 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 23, 2007)		 Weight loss, physical fitness and quality of life
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lifestyle Intervention in Morbidly Obese Patients
Official Title  ICMJE Lifestyle Intervention in Morbidly Obese Patients
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Morbid Obesity
Intervention  ICMJE Behavioral: Lifestyle intervention
Intensive lifestyle intervention at a rehabilitation centre 3 times a week the first 3 months of study
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Lifestyle intervention
  • Active Comparator: MLI
    Moderate lifestyle intervention at a secondary care outpatient center. Treatment included moderate changes in dietary habits (calori restriction) and physical activity.
    Intervention: Behavioral: Lifestyle intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 23, 2007)		 100
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00464984
Other Study ID Numbers  ICMJE S-05175.1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jøran Hjelmesæth, The Hospital of Vestfold
Study Sponsor  ICMJE The Hospital of Vestfold
Collaborators  ICMJE Oslo University Hospital
Investigators  ICMJE
Study Chair: Jøran Hjelmesæth, MD, PhD Morbid Obesity Center, Hospital of Vestfold, Boks 2168, NORWAY
PRS Account The Hospital of Vestfold
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP