The effect of low energy diet in combination with cognitive behavioral therapy and intragastric balloons on weight loss and weight maintenance: a randomized controlled trial

A randomized controlled trial in which we will assess the added value of an intragastric balloon to treatment with low energy diet and cognitive behavioral therapy in patients with obesity. Primary outcome measures comprise absolute weight loss as well as weight loss maintenance. Secondary outcome measures comprise effects on glucose metabolism and predictive factors regarding balloon tolerability. 

Both psychometric and physiologic parameters, as well as a number of biological parameters will be obtained, in order to predict which patient will have most benefit from this treatment.