Rationale and design of a feasibility and acceptability RCT of romantic partner and support figure attendance during bariatric surgery visits

• Main Authors: Megan Ferriby, Keeley Pratt, Lorraine Wallace, Brian C. Focht, Sabrena Noria, Bradley Needleman
• Format: Article
• Language: English
• Published: Elsevier 2019-09-01
• Series: Contemporary Clinical Trials Communications
• Online Access: http://www.sciencedirect.com/science/article/pii/S2451865419300146

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. Keywords: Bariatric surgery, Romantic relationships, Social support, Randomized control trial