CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 63 enrolled
Drug / intervention
Attendancebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03642197
NCT03642197N/ACompleted

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

Ohio State University·interventional·Posted Aug 22, 2018·Updated Sep 30, 2025

In Brief

A clinical study evaluating Attendance for Obesity, Morbid and 4 related conditions. Completed, enrolled 63 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 22, 2018
Enrollment StartAug 1, 2018
Primary CompletionAug 15, 2019
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 7.9 years ago

Interventions

Attendancebehavioral

The SFA and PA arms will be instructed to attend pre-surgery classes and clinical visits with the patients.