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Does a Virtual Coach Offer a Better Solution for Weight Reduction in Ventral Hernia Patients With Obesity?

Primary Purpose

Obesity, Ventral Hernia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MyChart enabled virtual weight loss coach
Standard preoperative weight loss tools
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Subjects between 18 and 90 years of age with a Body Mass Index (BMI) of 30 and above and diagnosed with Obesity by the ICD 10 Code: E66.9 who have been evaluated by a surgeon and offered elective ventral hernia repair. Also, participants must have a complete medical record that allows for all statistical calculations to be performed. Exclusion Criteria: Pregnant females, patients with severe mental disorders, prescribed psychiatric medications associated with weight gain, a history of a Substance Use Disorder, patients on long-term steroid therapy, and patients with insufficient medical records.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Virtual coach

    Standard weight loss tools

    Arm Description

    Participants will utilize the MyChart enabled virtual coach to aid preoperative weight loss.

    Participants will not utilize the MyChart enabled virtual coach to aid preoperative weight loss, but instead use standard weight loss tools.

    Outcomes

    Primary Outcome Measures

    pounds of weight change per group
    Average net amount of weight

    Secondary Outcome Measures

    number of interactions
    number of interactions with virtual coach per subject
    degree of quality of life
    quality of life measured per the 12-question Hernia Related Quality of Life Survey (HerQLes), a self-reported outcome measure questionnaire
    degree of satisfaction with the virtual coach
    degree of satisfaction with use of the virtual coach measured via single 7 point Likert scale question

    Full Information

    First Posted
    March 16, 2023
    Last Updated
    August 3, 2023
    Sponsor
    University of Florida
    Collaborators
    National Center for Advancing Translational Sciences (NCATS)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05797974
    Brief Title
    Does a Virtual Coach Offer a Better Solution for Weight Reduction in Ventral Hernia Patients With Obesity?
    Official Title
    Does a Virtual Coach Offer a Better Solution for Weight Reduction in Ventral Hernia Patients With Obesity?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    April 30, 2024 (Anticipated)
    Study Completion Date
    October 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Florida
    Collaborators
    National Center for Advancing Translational Sciences (NCATS)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose for this research is to create a MyChart-enabled virtual coach that assists obese patients lose weight prior to ventral hernia surgery. Researchers intend to show how the use of a virtual coach is more effective in preoperative weight reduction prior to ventral hernia repair over usual care. Correspondingly, this may lower unplanned hospital readmissions. For this clinical trial, where randomization is not possible, the study team will implement the use of propensity score matching that sorts individuals into different study arms as if randomly assigned. The primary outcome is the average net amount of time-dependent weight change per group over six months. Secondary outcomes are for the intervention group, patient satisfaction with the virtual coach and for both groups, quality of life. In addition, areas of social and economic disadvantage will be identified that may contribute to higher obesity rates. Machine learning (ML) modeling will be used to determine the important features for weight lost over the course of the study. The impact of this work will be to demonstrate efficacy and realized workflow efficiencies within a hospital-based surgery clinic.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Ventral Hernia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Virtual coach
    Arm Type
    Experimental
    Arm Description
    Participants will utilize the MyChart enabled virtual coach to aid preoperative weight loss.
    Arm Title
    Standard weight loss tools
    Arm Type
    Active Comparator
    Arm Description
    Participants will not utilize the MyChart enabled virtual coach to aid preoperative weight loss, but instead use standard weight loss tools.
    Intervention Type
    Other
    Intervention Name(s)
    MyChart enabled virtual weight loss coach
    Intervention Description
    MyChart-enabled virtual coach utilized to aid in preoperative weight loss.
    Intervention Type
    Other
    Intervention Name(s)
    Standard preoperative weight loss tools
    Intervention Description
    Participants will utilize current standard preoperative weight loss tools.
    Primary Outcome Measure Information:
    Title
    pounds of weight change per group
    Description
    Average net amount of weight
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    number of interactions
    Description
    number of interactions with virtual coach per subject
    Time Frame
    6 months
    Title
    degree of quality of life
    Description
    quality of life measured per the 12-question Hernia Related Quality of Life Survey (HerQLes), a self-reported outcome measure questionnaire
    Time Frame
    at baseline and 6 months
    Title
    degree of satisfaction with the virtual coach
    Description
    degree of satisfaction with use of the virtual coach measured via single 7 point Likert scale question
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subjects between 18 and 90 years of age with a Body Mass Index (BMI) of 30 and above and diagnosed with Obesity by the ICD 10 Code: E66.9 who have been evaluated by a surgeon and offered elective ventral hernia repair. Also, participants must have a complete medical record that allows for all statistical calculations to be performed. Exclusion Criteria: Pregnant females, patients with severe mental disorders, prescribed psychiatric medications associated with weight gain, a history of a Substance Use Disorder, patients on long-term steroid therapy, and patients with insufficient medical records.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jana Sacco, MD
    Phone
    (904)244-3943
    Email
    jana.sacco@jax.ufl.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jennifer Mull, MSN
    Phone
    (904) 244-7988
    Email
    jennifer.mull@jax.ufl.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Does a Virtual Coach Offer a Better Solution for Weight Reduction in Ventral Hernia Patients With Obesity?

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