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

The Effect of Lifestyle Intervention Versus Gastric Bypass on Various Comorbidities in Morbidly Obese Subjects

This study has been completed.
Sponsor:
Collaborator:
South-Eastern Norway Regional Health Authority
Information provided by (Responsible Party):
Jøran Hjelmesæth, The Hospital of Vestfold
ClinicalTrials.gov Identifier:
NCT00273104
First received: January 5, 2006
Last updated: February 17, 2015
Last verified: February 2015

January 5, 2006
February 17, 2015
December 2005
December 2009   (final data collection date for primary outcome measure)
Improvement of co-morbidities [ Time Frame: 1-year after treatment start ] [ Designated as safety issue: Yes ]
1-year comparative nonrandomized controlled trial
Improvement of co-morbidities
Complete list of historical versions of study NCT00273104 on ClinicalTrials.gov Archive Site
Safety issues [ Time Frame: 1-year ] [ Designated as safety issue: Yes ]
Surgical complications and serious adverse events in both groups as published
Not Provided
Not Provided
Not Provided
 
The Effect of Lifestyle Intervention Versus Gastric Bypass on Various Comorbidities in Morbidly Obese Subjects
The Effect of Lifestyle Intervention vs Gastric Bypass on Various Comorbidities

This follow up study (>1 year) aims to compare the effects of lifestyle intervention and gastric by pass surgery on various comorbidities associated with morbid obesity.

Not addressed

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Obstructive Sleep Apnea
  • Diabetes Mellitus
  • Hypertension
  • Procedure: Bariatric surgery
    Bariatric surgery as a part of public health service offered treatment seeking morbidly obese patients.
  • Behavioral: Intensive lifestyle intervention
    Intensive lifestyle intervention as a part of public health service offered treatment seeking morbidly obese patients.
  • Active Comparator: Bariatric surgery
    Bariatric surgery (gastric bypass) offered to patients after informed consent and shared decision. The surgical procedure was performed at Vestfold Hospital Trust by experienced bariatric surgeons.
    Intervention: Procedure: Bariatric surgery
  • Active Comparator: Intensive lifestyle intervention
    Intensive lifestyle intervention (1-year endurance) at a rehabilitation centre. The intervention consisted of motivation for behaviour change including calorie restriction and increased physical activity.
    Intervention: Behavioral: Intensive lifestyle intervention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
December 2014
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Morbidly obese patients

Exclusion Criteria:

-

Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00273104
S-05175
No
Jøran Hjelmesæth, The Hospital of Vestfold
The Hospital of Vestfold
South-Eastern Norway Regional Health Authority
Principal Investigator: Jøran Hjelmesæth, MD PhD Hospital of Vestfold
The Hospital of Vestfold
February 2015

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