Protocol for: The Use of Intra-Gastric Balloons as an Adjunct to a Lifestyle Support Programme to Promote Weight Loss in Severely Obese AdolescentsReece LJ1*, Copeland RJ1, Sachdev P2, Thomson M3, Wales JK2 and Wright NP2
- *Corresponding Author:
- Reece LJ
Sheffield Hallam University
HWB, Collegiate Hall
Centre for Sport and Exercise Science
Sheffield Hallam University, Sheffield
S10 2BP, UK
E-mail: [email protected]
Received Date: October 21, 2013; Accepted Date: November 11, 2014; Published Date: November 14, 2014
Citation: Reece LJ, Copeland RJ, Sachdev P, Thomson M, Wales JK et al. (2014) Protocol for: The Use of Intra-Gastric Balloons as an Adjunct to a Lifestyle Support Programme to Promote Weight Loss in Severely Obese Adolescents. J Child Adolesc Behav 2:173 doi:10.4172/2375-4494.1000173
Copyright: © 2014 Reece LJ, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Background: Severe childhood and adolescent obesity (BMI>3.5SD) remains a significant public health priority with an increasing incidence and is associated with significant morbidity including immediate and long-term cardiovascular, metabolic and psychological consequences. Current non-invasive treatments including lifestyle modification and pharmaceutical intervention are of limited effectiveness in this population, which leaves permanent bariatric surgery as the only viable option. As an alternative, intra-gastric balloons offer a reversible, potentially safer and less invasive option for severely obese adolescents for whom all other available treatments have been exhausted. Methods/design: BOB is a non-randomised pilot study. A cohort of 12 obese adolescents (BMI > 3.5SD, puberty stage 4 or more) aged 13 - 16 years, will be recruited to the study, where an intragastric balloon (ORBERA – inflated to 500-700ml) will be inserted into the stomach for 6 months, whilst receiving intense, weekly, behavioural support for the family. Follow-up will continue for 18 months after balloon removal with reduced behavioural support. The primary outcome measure will be the change in body weight and BMI standard deviation score from baseline following six months with the intragastric balloon and lifestyle therapy. Secondary outcome measures include the assessment of weight maintenance at 18 months post balloon removal, biomedical outcomes including blood glucose levels, physical activity and physical fitness, and psychosocial outcomes such as paediatric health-related quality of life.