Obesity, Ventral Hernia
Conditions
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.
Interventions
OTHERMyChart enabled virtual weight loss coach
MyChart-enabled virtual coach utilized to aid in preoperative weight loss.
OTHERStandard preoperative weight loss tools
Participants will utilize current standard preoperative weight loss tools.
Sponsors
National Center for Advancing Translational Sciences (NCATS)
University of Florida
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pounds of Weight Change Per Group | 6 months | Average net amount of weight change |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Interactions | 6 months | number of interactions with virtual coach per subject; interactions were determined as a digital responses logged from participants in the electronic medical record (MyChart) |
| Degree of Quality of Life | at baseline | 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. |
| Degree of Satisfaction With the Virtual Coach | 6 months | 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. |
Countries
United States
Participant flow
Recruitment details
First participant enrolled February 15, 2024 in ambulatory surgical clinic.
Pre-assignment details
Of 33 enrolled participants, 32 met inclusion criteria and were included in study participation.
Participants by arm
| Arm | Count |
|---|---|
| Virtual Coach Participants will utilize the MyChart enabled virtual coach to aid preoperative weight loss.
MyChart enabled virtual weight loss coach: MyChart-enabled virtual coach utilized to aid in preoperative weight loss. | 28 |
| 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.
Standard preoperative weight loss tools: Participants will utilize current standard preoperative weight loss tools. | 4 |
| Total | 32 |
Baseline characteristics
| Characteristic | Virtual Coach | Standard Weight Loss Tools | Total |
|---|---|---|---|
| Age, Continuous | 50 years | 58 years | 51 years |
| Body Mass Index | 45 kg/m^2 | 40 kg/m^2 | 44 kg/m^2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 1 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 13 Participants | 3 Participants | 16 Participants |
| Sex: Female, Male Female | 22 Participants | 1 Participants | 23 Participants |
| Sex: Female, Male Male | 6 Participants | 3 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 4 |
| other Total, other adverse events | 0 / 28 | 0 / 4 |
| serious Total, serious adverse events | 0 / 28 | 0 / 4 |
Outcome results
Primary
Pounds of Weight Change Per Group
Average net amount of weight change
Time frame: 6 months
Population: Intent to treat population (all participants assigned to virtual coach or standard weight loss tool)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Coach | Pounds of Weight Change Per Group | 24.25 lbs | Standard Deviation 9.95 |
| Standard Weight Loss Tools | Pounds of Weight Change Per Group | 24.25 lbs | Standard Deviation 9.95 |
Secondary
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.
Time frame: at baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Coach | Degree of Quality of Life | 46.19 score on a scale | Standard Deviation 18.11 |
| Standard Weight Loss Tools | Degree of Quality of Life | 46.19 score on a scale | Standard Deviation 18.11 |
Secondary
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.
Time frame: 6 months
Population: Insufficient participation in 6 month survey to calculate degree of significance for outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Virtual Coach | Degree of Satisfaction With the Virtual Coach | 3 score on a scale |
Secondary
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)
Time frame: 6 months
Population: 3 of the 25 virtual coach participants completed the 6 month survey
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Virtual Coach | Number of Interactions | 9 number of interactions |