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

NCT05797974 | Completed Results

• 2 other identifiers: 202300391UL1TR001427
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Ventral Hernia

Outcome Measures

Primary Outcomes (1)

• Pounds of Weight Change Per Group

  Average net amount of weight change

  6 months

Secondary Outcomes (3)

• Number of Interactions

  6 months

• Degree of Quality of Life

  at baseline

• Degree of Satisfaction With the Virtual Coach

  6 months

Study Arms (2)

Virtual coach

EXPERIMENTAL

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

Other: MyChart enabled virtual weight loss coach

Standard weight loss tools

ACTIVE COMPARATOR

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

Interventions

MyChart enabled virtual weight loss coach OTHER

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

Virtual coach

Standard preoperative weight loss tools OTHER

Participants will utilize current standard preoperative weight loss tools.

Standard weight loss tools

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of Florida Jacksonville

Jacksonville, Florida, 32209, United States

Location

MeSH Terms

Conditions

Obesity; Hernia, Ventral

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical

Limitations and Caveats

Insufficient participation in 6 month surveys to calculate degree of significance for outcome measures.

Results Point of Contact

• Title: Dr. Jana Sacco
• Organization: University of Florida

Jana.Sacco@jax.ufl.edu

904-244-7418

Study Officials

• Jana Sacco, MD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 4, 2023
• Study Start: February 15, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: November 20, 2025
• Results First Posted: November 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)