The Effect of Lifestyle Intervention Versus Gastric Bypass on Various Comorbidities in Morbidly Obese Subjects
|ClinicalTrials.gov Identifier: NCT00273104|
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : April 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea Diabetes Mellitus Hypertension||Procedure: Bariatric surgery Behavioral: Intensive lifestyle intervention||Not Applicable|
|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|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2017|
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
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|