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首页> 外文期刊>Contemporary Clinical Trials Communications >Rationale and design of a feasibility and acceptability RCT of romantic partner and support figure attendance during bariatric surgery visits
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Rationale and design of a feasibility and acceptability RCT of romantic partner and support figure attendance during bariatric surgery visits

机译:减肥手术期间浪漫伴侣和支持者出席的可行性和可接受性RCT的原理和设计

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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.
机译:随着美国肥胖率的上升,更多的患者,尤其是女性,正在寻求减肥手术。由于减肥手术患者的社会支持已被大大地研究,临床医生和研究人员对于如何在手术过程中纳入包括浪漫伴侣在内的支持者的信息有限。为了解决这一知识差距,我们正在进行四臂随机对照试验,以评估在110名18岁或以上年龄的女性减肥手术过程中纳入浪漫伴侣和支持者的可行性,可接受性和初步疗效。年长的。将根据基线时他们同居的恋爱关系将患者随机分组。具有同居浪漫伴侣的女性患者将被随机分配到以下两个武器之一:伴侣参加(PA)和伴侣照常接受治疗(PA-TU)。为了提供有关减重过程中社会支持的更多详细信息,将不存在同居恋爱关系的感兴趣的患者(女性或男性)随机分为参加支持的人(SFA)和SFA-TU。计划四个数据收集点,包括手术前4个月,手术前2周,手术后2周和2个月。在最终数据点收集的支持人员/合作伙伴出勤的可行性和可接受性。患者和支持者/伙伴将在每个时间点完成体重状况,健康行为,对行为改变的支持以及关系质量评估。描述了研究的基本原理,设计,理论框架和方法。这项研究的结果将确定支持者/伴侣如何影响患者的健康行为变化和体重减轻,以及在整个手术过程中关系如何变化。

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