The Effect of Lifestyle Intervention Versus Gastric Bypass on Various Comorbidities in Morbidly Obese Subjects
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00273104|
Recruitment Status : Active, not recruiting
First Posted : January 9, 2006
Last Update Posted : June 1, 2017
|Condition or disease||Intervention/treatment|
|Obstructive Sleep Apnea Diabetes Mellitus Hypertension||Procedure: Bariatric surgery Behavioral: Intensive lifestyle intervention|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Lifestyle Intervention vs Gastric Bypass on Various Comorbidities|
|Study Start Date :||December 2005|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2025|
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.
- Improvement of co-morbidities [ Time Frame: 1-year after treatment start ]1-year comparative nonrandomized controlled trial
- Safety issues [ Time Frame: 1-year ]Surgical complications and serious adverse events in both groups as published
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00273104
|Hospital in Vestfold|
|Tonsberg, Norway, 3117|
|Principal Investigator:||Jøran Hjelmesæth, MD PhD||Hospital of Vestfold|