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

Megan Ferriby; Keeley Pratt; Lorraine Wallace; Brian C Focht; Sabrena Noria; Bradley Needleman

doi:10.1016/j.conctc.2019.100422

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

Contemp Clin Trials Commun. 2019 Jul 24:15:100422. doi: 10.1016/j.conctc.2019.100422. eCollection 2019 Sep.

Authors

Megan Ferriby¹, Keeley Pratt^{1

2}, Lorraine Wallace³, Brian C Focht⁴, Sabrena Noria², Bradley Needleman²

Affiliations

¹ Department of Human Sciences, Human Development and Family Sciences Program, The Ohio State University, United States.
² Department of Surgery, Division of General and Gastrointestinal Surgery, The Ohio State University, United States.
³ Department of Biomedical Education and Anatomy, Division of Biomedical Education, The Ohio State University, United States.
⁴ Department of Human Sciences, Kinesiology Program, The Ohio State University, United States.

Abstract

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: BMI, Body Mass Index; BS, Bariatric Surgery; Bariatric surgery; PA, Partner Attended; PA-TU, Partner Attended Treatment as Usual; Randomized control trial; Romantic relationships; SFA, Support Figure Attended; SFA-TU, Support Figure Attended – Treatment as Usual; Social support.