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

Not Applicable

Completed

• Conditions: Obesity; Ventral Hernia
• Interventions: Other: Standard preoperative weight loss tools; Other: MyChart enabled virtual weight loss coach

• Registration Number: NCT05797974
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-16
• Study First Submitted QC: 2023-04-03
• Study First Posted: 2023-04-04
• Study Start: 2024-02-01
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
pounds of weight change per group	6 months	Average net amount of weight

Secondary Outcome Measures

Name	Time	Method
degree of satisfaction with the virtual coach	6 months	degree of satisfaction with use of the virtual coach measured via single 7 point Likert scale question
number of interactions	6 months	number of interactions with virtual coach per subject
degree of quality of life	at baseline and 6 months	quality of life measured per the 12-question Hernia Related Quality of Life Survey (HerQLes), a self-reported outcome measure questionnaire

Trial Locations

Locations (1)

University of Florida Jacksonville; 🇺🇸 Jacksonville, Florida, United States