Jacqueline Curran; Liz Davis; Colin Sherrington; Tim Jones
Study Staff: Leticia Good; Rachelle Kalic; Luise Russel; Deanna Messina; Anna Tremayne
Weight loss treatments for adolescents who are overweight or obese include lifestyle changes that includes diet, exercise, parental involvement, reinforcement, stimulus control and self-monitoring as targeted interventions. These lifestyle interventions in children have found to result in a mean sustainable excess weight loss of 8%. Pharmacotherapy has a very limited role in the treatment of adolescent obesity, compliance is often poor and drug choices are limited.
Studies of bariatric surgery highlight the potential weight loss that can be achieved in obese patients with the subsequent improved health, complication rates unfortunately remain high. In obese adolescents who fail to lose weight with lifestyle alone surgery is increasingly being considered. However there are currently no predictors to determine which adolescents will get complications from Laparoscopic Adjustable Gastric Banding or bypass surgery. Likewise there are no reliable predictors to determine which adolescents will have a good response from surgery, there is no available risk benefits data.
A less invasive option is the gastric balloon, achieving a temporary restriction of food intake in combination with lifestyle and behavioural changes the aim being to achieve long term weight loss. This has been achieved in adults with the use of a gastric balloon that floats in the stomach giving the individual the sensation of continued satiety, reducing their requirement and desire for food. While there have been large studies on the successful use of the BIB in obese adults. Only one small (n=5) retrospective study has been performed in adolescents with the use of the BIB. The purpose of this randomized clinical trial is to determine whether the use of the BIB aids weight loss in obese adolescents.
Specifically, that:
- The BIB aids weight loss in obese adolescent patients.
- The BIB will be well tolerated in obese adolescent patients.
- The BIB will reduce the severity and frequency of obesity related co-morbidities in obese adolescents.
50 adolescent patients (male and female), age 12-17 years attending Princess Margaret Hospital (PMH) will recruited to the study.
Plain language summary: Being overweight or obese as a teenager has damaging effects on the teenagers health, with increased risk of many diseases such as diabetes, heart disease, liver disease and depression. Losing weight stops some of these diseases occurring and can help turn around some diseases that are already present. Doing more exercise and eating a healthier diet (lifestyle change) are good ways to lose weight, however weight loss is often slow with lifestyle changes alone and drive can be hard to keep up. Some other treatments have been tried to help people lose weight while they are changing their lifestyles. One of these is to reduce the space in the stomach available for food with a fluid filled balloon (called BIB). It has been tried in overweight adults with success, but not in teenagers. The aim of this study are to see if the balloon is safe to use in teenagers, to see how much weight they can lose and to see if the balloon can turn around some disease in overweight teenagers.
Funder: NHMRC # 634308; Pfizer APEC Grant