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

Study Overview
=================
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.

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

Conditions
-----------------
Obesity, Ventral Hernia

Intervention / Treatment
-----------------
* Other: MyChart enabled virtual weight loss coach
* Other: Standard preoperative weight loss tools


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual coach<br>Participants will utilize the MyChart enabled virtual coach to aid preoperative weight loss. | Other: MyChart enabled virtual weight loss coach<br>* MyChart-enabled virtual coach utilized to aid in preoperative weight loss.<br>|
| Active Comparator: Standard weight loss tools<br>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<br>* Participants will utilize current standard preoperative weight loss tools.<br>|

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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of interactions | number of interactions with virtual coach per subject | 6 months | 
| 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 | 
| 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 |