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Lifestyle Intervention in Morbidly Obese Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Jøran Hjelmesæth, The Hospital of Vestfold
ClinicalTrials.gov Identifier:
NCT00464984
First received: April 23, 2007
Last updated: August 18, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention Phase
Morbid Obesity
 Behavioral: Lifestyle intervention
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lifestyle Intervention in Morbidly Obese Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Hospital of Vestfold:

Primary Outcome Measures:
  • Weight loss, physical fitness and quality of life [ Time Frame: 1 and 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2006
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Lifestyle intervention
    Intensive lifestyle intervention at a rehabilitation centre 3 times a week the first 3 months of study
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: April 23, 2007
Last Updated: August 18, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

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

ClinicalTrials.gov processed this record on May 23, 2013