Randomized controlled trial protocol: A quanti-quali approach for analyzing the results of an intervention on the waiting list for bariatric surgery

ABSTRACT Objective This article aims to describe the protocol of a randomized clinical trial and the baseline results of the study of a one-year interdisciplinary intervention in users of the public health system in the bariatric surgery waiting list. Methods A randomized, single-blind clinical trial will be conducted including 88 participants recruited on an outpatient clinic of the public health system. Participants were randomized into the control group (n=44), receiving the usual treatment; and into the intervention group (n=44), participating in the educational intervention. Participants had their food intake, negative affectivity and physical inactivity/sedentary behavior assessed, as well as anthropometric and body composition measurements; their blood samples were collected; and also had different physical capacity tests. Results Of the 157 participants invited, 27 had severe functional limitations, one was under-age, and four declined the study due to associated diseases. Eighty-eight participants were randomized: 44 for the Control Group and 44 for the Intervention Group. When comparing the demographic and biochemical characteristics, there were no differences between groups except for serum glucose (GC=110.4±46.8mg/dL and GI93.1±16.9mg/dL, p=0.039). Conclusion This study protocol describes the methodology used in the study of educational intervention for the promotion of health care of patients on the waiting list for bariatric surgery. It shows that there is similarity between the baseline comparison groups. Registro Brasileiro de Ensaios Clínicos (Brazilian Clinical Trials Registry), RBR-775y3d.

【摘要】
研究目的：本文旨在阐述一项针对公共卫生系统内减重手术（bariatric surgery）等候队列人群开展的为期一年的多学科干预随机对照试验（randomized clinical trial）的试验方案，以及该研究的基线结果。
研究方法：本研究将开展一项随机单盲临床试验（single-blind clinical trial），共纳入88名来自公共卫生系统门诊招募的受试者。受试者被随机分为对照组（n=44，接受常规治疗）与干预组（n=44，参与本次教育干预）。研究人员将对受试者的膳食摄入、负性情感状态、体力活动不足/久坐行为进行评估，同时开展人体测量学与身体成分检测；采集血液样本，并完成多项体能测试。
研究结果：在受邀的157名受试者中，27名存在严重功能障碍，1名未成年，另有4名因合并疾病拒绝参与本研究。最终共88名受试者完成随机分组：对照组44名，干预组44名。对两组的人口学与生化特征进行比较后发现，除血清葡萄糖水平外（对照组：110.4±46.8mg/dL，干预组：93.1±16.9mg/dL，p=0.039），其余指标组间均无显著差异。
研究结论：本研究方案阐明了针对减重手术等候患者开展健康照护促进教育干预的研究方法，结果显示两组基线特征具有良好的均衡性。
本研究已在巴西临床试验注册库（Registro Brasileiro de Ensaios Clínicos）注册，注册号为RBR-775y3d。