Suboptimal Weight Loss After Gastric Bypass Surgery
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.
Behavioral: Multidisciplinary outpatient programme
Behavioral: Inpatient lifestyle programme
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the Efficacy of Two Lifestyle Interventions for Suboptimal Weight Loss After Gastric Bypass Surgery|
- Weight loss change [ Time Frame: from baseline to 1 year ] [ Designated as safety issue: No ]Changes in body weight will be assessed at the end of the intervention (1 year)
- Risk factors [ Time Frame: One year ] [ Designated as safety issue: No ]Risk factors: fasting plasma glucose and lipids (triglycerides, total cholesterol, HDL cholesterol) and blood pressure will be assessed
|Study Start Date:||August 2013|
|Study Completion Date:||August 2014|
|Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Experimental: Outpatient group
Multidisciplinary outpatient programme including both individual and group-based therapy. During the first visit, every patient will have an individual consultation with the dietician, physiotherapist and psychiatric nurse. After this, the patients will be followed up in groups every month for the first four months and every two months afterwards up to one year. The intervention will focus on nutritional education, healthy eating, increased physical activity levels (aiming initially at 10 minutes/day, then increasing to 30 minutes/day) and cognitive therapy.
|Behavioral: Multidisciplinary outpatient programme|
Experimental: Inpatient group
Inpatient lifestyle programme offered at a rehabilitation center consisting of a "continuous care" weight loss program, with three intermittent stays (each with three-week duration) over a one year period.
|Behavioral: Inpatient lifestyle programme|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01829906
|St. Olavs Hospital|
|Study Director:||Bård Kulseng, md phd||Norwegian University of Science and Technology|