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.

Study Overview

• Status: Completed
• Conditions: Obesity; Ventral Hernia
• Intervention / Treatment: Other: MyChart enabled virtual weight loss coach; Other: Standard preoperative weight loss tools

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32209
      • University of Florida Jacksonville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual coach; Participants will utilize the MyChart enabled virtual coach to aid preoperative weight loss.	Other: MyChart enabled virtual weight loss coach; MyChart-enabled virtual coach utilized to aid in preoperative weight loss.
Active Comparator: Standard weight loss tools; Participants will not utilize the MyChart enabled virtual coach to aid preoperative weight loss, but instead use standard weight loss tools.	Other: Standard preoperative weight loss tools; Participants will utilize current standard preoperative weight loss tools.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pounds of Weight Change Per Group	Average net amount of weight change	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Interactions	number of interactions with virtual coach per subject; interactions were determined as a digital responses logged from participants in the electronic medical record (MyChart)	6 months
Degree of Quality of Life	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.	at baseline
Degree of Satisfaction With the Virtual Coach	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.	6 months

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Jana Sacco, MD, Assistant Professor

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: March 16, 2023
• First Submitted That Met QC Criteria: April 3, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Pathological Conditions, Anatomical; Overnutrition; Body Weight; Hernia; Overweight; Hernia, Abdominal; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Hernia, Ventral
• Other Study ID Numbers: 202300391; UL1TR001427 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No