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NCT03642197 · ClinicalTrials.gov registry record · NA
Feasibility and Preliminary Efficacy of Support Figure Attendance at Bariatric Patients' Clinical Visits
A NA study, sponsored by Ohio State University.
- Completed
- Registry status
- NA
- Development phase
- 63
- Enrollment target
NCT03642197 is a NA study that has completed, run by Ohio State University. The registered enrollment target is 63 participants.
The verdict
NCT03642197, a NA study, has completed, sponsored by Ohio State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 63 participants
- Enrollment target
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.
Interventions
- BEHAVIORAL Attendance
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2018-08-01 |
| Est. Completion | 2019-08-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03642197
The ClinicalTrials.gov registry entry for NCT03642197 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Attendance is the first listed.
NCT03642197 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03642197 about?
NCT03642197 is a clinical study titled "Feasibility and Preliminary Efficacy of Support Figure Attendance at Bariatric Patients' Clinical Visits". 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 ...
What is the current status of trial NCT03642197?
This trial is currently completed. It is a NA study. The enrollment target is 63 participants. The study started on 2018-08-01. Estimated completion is 2019-08-15.
What interventions are being tested in trial NCT03642197?
The interventions under investigation include: Attendance (BEHAVIORAL).
Who is sponsoring clinical trial NCT03642197?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
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