Suboptimal Weight Loss After Gastric Bypass Surgery
- Conditions
- Obesity, Morbid
- Registration Number
- NCT01829906
- Lead Sponsor
- Norwegian University of Science and Technology
- Brief Summary
Bariatric surgery is the only long-term established treatment for morbid obesity. However, some patients experience suboptimal weight loss after surgery and/or experience a significant weight regain. Unfortunately there are very few studies in this area and little is known about the causes for lack of success or the best approach to treat this group of patients. The main aim of this study is to compare the efficacy of two different lifestyle treatment programs in this group of patients: 1) Hospital-based outpatient program or 2) an inpatient treatment program consisting of 3 - 3-week stays at a rehabilitation center over a 1-year period. Secondary aim is to determine potential reasons for suboptimal weight loss after bariatric surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 49
- Body mass index (BMI) >40kg/m2, or BMI>35kg/m2 with comorbidities
- healthy volunteers with suboptimal weight loss
- health with significant weight regain after Roux-n-Y Gastric Bypass, defined as failure to lose at least 40% Excess Weight Loss by 12 months postoperatively.
Significant weight regain: Regain of ≥15% of total weight lost after the first postoperative year.
- Pregnancy
- enrollment in another obesity treatment
- previous revisional bariatric surgery
- planned bariatric surgery
- past or ongoing drug or alcohol abuse
- physical or mental impairment that interferes with the ability to comply to treatment
- history of severe psychological disorder
- history of severe eating disorder
- current medication known to affect appetite or induce weight loss
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Weight loss change from baseline to 1 year Changes in body weight will be assessed at the end of the intervention (1 year)
- Secondary Outcome Measures
Name Time Method Risk factors One year Risk factors: fasting plasma glucose and lipids (triglycerides, total cholesterol, HDL cholesterol) and blood pressure will be assessed
Trial Locations
- Locations (1)
St. Olavs Hospital
🇳🇴Trondheim, Norway
St. Olavs Hospital🇳🇴Trondheim, Norway