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OpenTrials
Completed

NCT Number: NCT05797974

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida Jacksonville

Jacksonville, Florida, 32209, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MyChart enabled virtual weight loss coach

Other

MyChart-enabled virtual coach utilized to aid in preoperative weight loss.

Standard preoperative weight loss tools

Other

Participants will utilize current standard preoperative weight loss tools.

Primary outcomes

  1. Pounds of Weight Change Per Group

    Time frame: 6 months

    Average net amount of weight change

Secondary outcomes

  1. Number of Interactions

    Time frame: 6 months

    number of interactions with virtual coach per subject; interactions were determined as a digital responses logged from participants in the electronic medical record (MyChart)

  2. Degree of Quality of Life

    Time frame: at baseline

    quality of life measured per the Hernia Related Quality of Life Survey (HerQLes), a validated self-reported 12-question tool used to assess the impact of a ventral hernia on a patient's quality of life and abdominal wall function. The tool helps measure a patient's quality of life before and after a ventral hernia repair (VHR). Scores are converted to a 0-100 scale, with higher scores indicating a better quality of life.

  3. Degree of Satisfaction With the Virtual Coach

    Time frame: 6 months

    Satisfaction with the virtual coach will be measured by a single question, "How satisfied are you with the virtual coach." and rated on a 7 point Likert scale, from 1, Not satisfied at all, 4 Neutral to 7, Very satisfied.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2023
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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