Smith Evelyn, Whittingham Charlotte
Eating Disorders and Obesity Psychology Research Clinic, School of Social Sciences and Psychology, Western Sydney University, Locked Bag 1747, Penrith 2751, Sydney, NSW, Australia.
Clinical and Health Psychology Research Initiative, School of Social Sciences and Psychology, Western Sydney University, Locked Bag 1747, Penrith 2751, Sydney, NSW, Australia.
Trials. 2017 Jan 26;18(1):42. doi: 10.1186/s13063-017-1778-x.
Current 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/DESIGN: One 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.
If 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.
The RCT is registered with the Australian New Zealand Registry of Clinical Trial, trial identifier: ACTRN12616000658415 . Registered on 20 May 2016.
当前研究表明，肥胖个体在执行功能方面存在认知缺陷，导致计划、冲动控制和决策困难。高水平炎症被认为是肥胖个体执行功能缺陷的一个原因。
方法/设计：176名肥胖参与者将被随机分为两组：（1）单纯行为减肥（BWL）组 = 8次个体BWL疗程加12次团体BWL疗程；或（2）肥胖认知矫正疗法（CRT - O）加BWL组（CRT - O + BWL） = 8次个体CRT - O疗程加12次团体BWL疗程。该研究为双盲研究——参与者仅被告知正在比较两种减肥治疗方法，进行结果评估的研究助理不知道参与者的分组情况。将进行血液检测以测量炎症标志物。测量点为基线、治疗后和1年随访。主要结果将是治疗组在体重减轻百分比、执行功能、暴饮暴食方面的差异，以及检查执行功能的变化是否能预测体重和暴饮暴食的变化。次要结果测量将检查炎症、生活质量和随意进食行为的变化，以及这些是否能预测执行功能和体重的变化。
如果CRT - O + BWL在长期帮助人们减肥方面比单纯BWL更有效，那么它应该能显著改善治疗效果。本研究扩展了我们最近的试验，该试验表明CRT - O可增强肥胖成年人的执行功能和减肥效果。本研究因几个因素而得到加强：它是双盲的，使用了积极对照，样本量更大，并且测量炎症以研究机制。
该随机对照试验已在澳大利亚新西兰临床试验注册中心注册，试验标识符：ACTRN126160006584 , 15。于2016年5月20日注册。
