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
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea
Diabetes Mellitus
Hypertension
Procedure: Bariatric surgery
Behavioral: Intensive lifestyle intervention

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Lifestyle Intervention vs Gastric Bypass on Various Comorbidities

Resource links provided by NLM:


Further study details as provided by The Hospital of Vestfold:

Primary Outcome Measures:
  • Improvement of co-morbidities [ Time Frame: 1-year after treatment start ] [ Designated as safety issue: Yes ]
    1-year comparative nonrandomized controlled trial


Secondary Outcome Measures:
  • Safety issues [ Time Frame: 1-year ] [ Designated as safety issue: Yes ]
    Surgical complications and serious adverse events in both groups as published


Enrollment: 180
Study Start Date: December 2005
Study Completion Date: December 2014
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: Bariatric surgery
Bariatric surgery as a part of public health service offered treatment seeking morbidly obese patients.
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.
Behavioral: Intensive lifestyle intervention
Intensive lifestyle intervention as a part of public health service offered treatment seeking morbidly obese patients.

Detailed Description:

Not addressed

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Morbidly obese patients

Exclusion Criteria:

-

  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: NCT00273104

Locations
Norway
Hospital in Vestfold
Tonsberg, Norway, 3117
Sponsors and Collaborators
The Hospital of Vestfold
South-Eastern Norway Regional Health Authority
Investigators
Principal Investigator: Jøran Hjelmesæth, MD PhD Hospital of Vestfold
  More Information

No publications provided by The Hospital of Vestfold

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jøran Hjelmesæth, Head of Morbid Obesity Centre, The Hospital of Vestfold
ClinicalTrials.gov Identifier: NCT00273104     History of Changes
Other Study ID Numbers: S-05175
Study First Received: January 5, 2006
Last Updated: February 17, 2015
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Apnea
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Sleep Apnea Syndromes
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on August 27, 2015