Lifestyle Intervention in Morbidly Obese Patients
Primary Purpose
Morbid Obesity
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Lifestyle intervention
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity focused on measuring Weight loss, Physical fitness, Quality of life
Eligibility 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
Sites / Locations
- Spesialsykehuset for Rehabilitering i Stavern
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
ILI-group
MLI
Arm Description
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.
Moderate lifestyle intervention at a secondary care outpatient center. Treatment included moderate changes in dietary habits (calori restriction) and physical activity.
Outcomes
Primary Outcome Measures
Weight loss, physical fitness and quality of life
Secondary Outcome Measures
Full Information
NCT ID
NCT00464984
First Posted
April 23, 2007
Last Updated
August 31, 2021
Sponsor
The Hospital of Vestfold
Collaborators
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00464984
Brief Title
Lifestyle Intervention in Morbidly Obese Patients
Official Title
Lifestyle Intervention in Morbidly Obese Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital of Vestfold
Collaborators
Oslo University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Weight loss, Physical fitness, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ILI-group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
MLI
Arm Type
Active Comparator
Arm Description
Moderate lifestyle intervention at a secondary care outpatient center. Treatment included moderate changes in dietary habits (calori restriction) and physical activity.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle intervention
Intervention Description
Intensive lifestyle intervention at a rehabilitation centre 3 times a week the first 3 months of study
Primary Outcome Measure Information:
Title
Weight loss, physical fitness and quality of life
Time Frame
1 and 4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jøran Hjelmesæth, MD, PhD
Organizational Affiliation
Morbid Obesity Center, Hospital of Vestfold, Boks 2168, NORWAY
Official's Role
Study Chair
Facility Information:
Facility Name
Spesialsykehuset for Rehabilitering i Stavern
City
Stavern
State/Province
Vestfold
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Lifestyle Intervention in Morbidly Obese Patients
We'll reach out to this number within 24 hrs