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

NCT ID: NCT05797974

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-15
• Study Completion Date: 2025-03-01

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Virtual coach

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

Group Type: EXPERIMENTAL

MyChart enabled virtual weight loss coach

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Standard preoperative weight loss tools

Intervention Type: OTHER

Participants will utilize current standard preoperative weight loss tools.

Interventions

MyChart enabled virtual weight loss coach

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

Intervention Type: OTHER

Standard preoperative weight loss tools

Participants will utilize current standard preoperative weight loss tools.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jana Sacco, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

University of Florida Jacksonville

Jacksonville, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

UL1TR001427

Identifier Type: NIH

Identifier Source: secondary_id

View Link

202300391

Identifier Type: -

Identifier Source: org_study_id