Abstract
BackgroundCurrent research indicates that obese individuals have cognitive deficits in executive function, leading to difficulties with planning, impulse control and decision-making. High levels of inflammation have been proposed to contribute to executive function deficits in individuals with obesity.Methods/designOne hundred and seventy-six obese participants will be randomly assigned to one of two groups: (1) behavioural weight loss alone (BWL) group = 8 sessions of individual BWL sessions plus 12 group BWL sessions or (2) Cognitive Remediation Therapy for Obesity (CRT-O) plus BWL group (CRT-O + BWL) = 8 sessions of individual CRT-O plus 12 group BWL sessions. The study is double blind – participants will only be told that two weight-loss treatments are being compared and research assistants conducting outcome assessments will not know participants’ group allocation. Blood tests will be conducted to measure inflammatory markers. Measurement points will be at baseline, post treatment and 1-year follow-up. The primary outcomes will be differences between treatment groups in percentage weight loss, executive function, binge eating and an examination of whether changes in executive function predict changes in weight and binge eating. Secondary outcome measures will examine changes on inflammation, quality of life, and grazing behaviour and whether these predict changes in executive function and weight.DiscussionIf CRT-O + BWL is more effective in assisting people to lose weight long term than BWL alone it should significantly improve treatment outcomes. This study expands upon our recent trial which showed that CRT-O enhanced executive function and weight loss in obese adults. The current study is strengthened by several factors: it is double-blind, it uses an active control, has a larger sample size, and measures inflammation to examine the mechanisms.Trial registrationThe RCT is registered with the Australian New Zealand Registry of Clinical Trial, trial identifier: ACTRN12616000658415. Registered on 20 May 2016.
Highlights
Current research indicates that obese individuals have cognitive deficits in executive function, leading to difficulties with planning, impulse control and decision-making
If Cognitive Remediation Therapy (CRT)-O + behavioural weight loss alone (BWL) is more effective in assisting people to lose weight long term than BWL alone it should significantly improve treatment outcomes
This study expands upon our recent trial which showed that Cognitive Remediation Therapy for Obesity (CRT-O) enhanced executive function and weight loss in obese adults
Summary
If CRT-O (plus BWL) is successful at assisting people to lose weight and to maintain the weight loss it would allow for the development of an intervention that could significantly improve treatment outcomes. Given the poor long-term outcomes for previously investigated treatments (excepting bariatric surgery reserved for the most severe cases) and the increasing public health burden of obesity, novel and integrative treatment approaches are urgently needed. Our RCT is designed to compare two groups, a CRTO (plus BWL) group to a BWL alone group. Additional file 1: SPIRIT 2013 Checklist: recommended items to address in a clinical trial protocol and related documents*.
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
