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

NCT03642197 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2025-09-30

No results posted yet for this study

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.

Conditions

  • Obesity, Morbid
  • Bariatric Surgery Candidate
  • Diet Habit
  • Behavior, Social
  • Physical Activity

Interventions

BEHAVIORAL

Attendance

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

Sponsors & Collaborators

  • Ohio State University

    lead OTHER

Principal Investigators

  • Keeley J Pratt, Ph.D. · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2019-08-15
Completion
2019-08-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03642197 on ClinicalTrials.gov