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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05797974
• Other study ID #: 202300391
• Secondary ID: UL1TR001427
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: University of Florida
• Contact: Jana Sacco, MD
• Phone: (904)244-3943
• Email: jana.sacco[@]jax.ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Obesity
• Ventral Hernia
• Weight Loss

Intervention

Other:
• MyChart enabled virtual weight loss coach
MyChart-enabled virtual coach utilized to aid in preoperative weight loss.
• Standard preoperative weight loss tools
Participants will utilize current standard preoperative weight loss tools.

Locations

Country	Name	City	State
United States	University of Florida Jacksonville	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pounds of weight change per group	Average net amount of weight	6 months
Secondary	number of interactions	number of interactions with virtual coach per subject	6 months
Secondary	degree of quality of life	quality of life measured per the 12-question Hernia Related Quality of Life Survey (HerQLes), a self-reported outcome measure questionnaire	at baseline and 6 months
Secondary	degree of satisfaction with the virtual coach	degree of satisfaction with use of the virtual coach measured via single 7 point Likert scale question	6 months