Ferriby Megan, Pratt Keeley, Wallace Lorraine, Focht Brian C, Noria Sabrena, Needleman Bradley
Department of Human Sciences, Human Development and Family Sciences Program, The Ohio State University, United States.
Department of Surgery, Division of General and Gastrointestinal Surgery, The Ohio State University, United States.
Contemp Clin Trials Commun. 2019 Jul 24;15:100422. doi: 10.1016/j.conctc.2019.100422. eCollection 2019 Sep.
As US obesity rates increase, more patients, particularly females, are seeking out bariatric surgery. As bariatric surgery patients' social supports have been vastly understudied, clinicians and researchers have limited information about how to include support figures, including romantic partners, in the surgery process. To address this gap in knowledge, we are conducting a four-arm randomized controlled trial to assess the feasibility, acceptability and preliminary efficacy for the inclusion of romantic partners and support figures throughout the bariatric surgery process for a group of 110 women age 18 years or older. Patients will be randomized based upon their cohabitating romantic relationships at baseline. Female patients who have a cohabitating romantic partner will be randomized to one of two arms: partner attended (PA), and partner attended treatment as usual (PA-TU). To provide greater detail about social support during the bariatric process, interested patients (female or male) not in cohabitating romantic relationships will be randomized into support figure attended (SFA) and SFA-TU arms. Four data collection points are planned, including 4-months pre-surgery, 2 weeks pre-surgery, 2 weeks and 2-months post-surgery. Feasibility and acceptability of support figure/partner attendance collected at the final data point. Patients and support figures/partners will complete weight status, health behaviors, support for behavior change and relationship quality assessments at each time point. The rationale, design, theoretical framework, and methodology for the study are described. The results of this study will identify how support figures/partners influence patients' health behavior change and weight loss, and how relationships change over the surgery process.
随着美国肥胖率的上升,越来越多的患者,尤其是女性,正在寻求减肥手术。由于对减肥手术患者的社会支持研究严重不足,临床医生和研究人员对于如何将包括浪漫伴侣在内的支持人员纳入手术过程的信息有限。为了填补这一知识空白,我们正在进行一项四臂随机对照试验,以评估将浪漫伴侣和支持人员纳入一组110名18岁及以上女性减肥手术全过程的可行性、可接受性和初步疗效。患者将根据其基线时的同居恋爱关系进行随机分组。有同居恋爱伴侣的女性患者将被随机分为两组之一:伴侣陪同组(PA)和伴侣陪同常规治疗组(PA-TU)。为了更详细地了解减肥过程中的社会支持情况,没有同居恋爱关系的感兴趣患者(女性或男性)将被随机分为支持人员陪同组(SFA)和SFA-TU组。计划设置四个数据收集点,包括术前4个月、术前2周、术后2周和术后2个月。在最后一个数据点收集支持人员/伴侣参与的可行性和可接受性数据。患者和支持人员/伴侣将在每个时间点完成体重状况、健康行为、行为改变支持和关系质量评估。描述了该研究的基本原理、设计、理论框架和方法。这项研究的结果将确定支持人员/伴侣如何影响患者的健康行为改变和体重减轻,以及关系在手术过程中如何变化。