Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: February 17, 2015
Last verified: February 2015
  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
Morbid Obesity
Behavioral: Lifestyle intervention

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:


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)
Arms Assigned Interventions
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

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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: February 17, 2015
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

ClinicalTrials.gov processed this record on February 27, 2015