Feasibility and Preliminary Efficacy of Support Figure Attendance at Bariatric Patients' Clinical Visits

Completed · Not applicable

Conditions studied: Obesity, Morbid, Bariatric Surgery Candidate, Diet Habit, Behavior, Social, Physical Activity

In brief

The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy for the inclusion of support figures and romantic partners throughout the bariatric surgery process, from pre-surgery to two months post-surgery. This will be done using a four-arm randomized controlled trial (RCT). Using simple randomization, female patients in romantic relationships will be randomized into partner attended (PA) groups and treatment as usual (PA-TU) groups; patients (female or male) not in romantic relationships will be randomized into support figure attended (SFA) and SFA-TU groups. The goals of this study are to provide preliminary evidence for including support figures/partners in patients' routine BS healthcare visits, including the subsequent impact on post-surgery patient and support figure/partner behavior change and weight loss, relationship outcomes, and exploration of barriers to support figure/partner involvement. Aim 1: To assess the feasibility and acceptability of support figure/partner involvement for BS patients. Feasibility will be assessed throughout the study by attendance at the four pre-surgery classes and the clinic visit assessment time points. Perceived fiscal and time involved in the study will be assessed. Acceptability will be assessed from patient and support figure/partner interviews regarding the barriers and benefits to attendance, and alternative mediums to engage support figures/partners. Aim 2: To evaluate the effect of support figure/partner attendance (SFA, PA arms) on patient weight loss, behavior change, and relationship outcomes from T1-T4. Estimates of effect size and variance in patient weight loss and behavior change will be collected from T1-T4 for comparison of the SFA/PA and SFA-TU/PA-TU arms.

Key facts

Study ID

NCT03642197

Run by

Ohio State University

People needed

63

Starts

2018-08-01

Expected to finish

2019-08-15

Last updated by the study team

2025-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients in all arms must be ≥18 years-old, seeking bariatric surgery, speak and read/write English
• Partners and support figures must be ≥18 years old, speak and read/write English, and have no prior history of BS
• Partners in the PA and PA-TAU arms must be in a romantic relationship and cohabitate with the patient for at least 6 months

You may not qualify if…

• No known terminal health diagnosis (i.e., Cancer)
• In the PA and PA-TAU arms, no known domestic violence or abuse between partners

Where it is running

• Martha Morehouse Pavillion — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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