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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001427 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual coach | Experimental | Participants will utilize the MyChart enabled virtual coach to aid preoperative weight loss. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyChart enabled virtual weight loss coach | Other | MyChart-enabled virtual coach utilized to aid in preoperative weight loss. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pounds of Weight Change Per Group | Average net amount of weight change | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 6 months |
| Degree of Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jana Sacco, MD | Assistant Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida Jacksonville | Jacksonville | Florida | 32209 | United States |
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Of 33 enrolled participants, 32 met inclusion criteria and were included in study participation.
First participant enrolled February 15, 2024 in ambulatory surgical clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Standard Weight Loss Tools |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pounds of Weight Change Per Group | Average net amount of weight change | Intent to treat population (all participants assigned to virtual coach or standard weight loss tool) | Posted | Mean | Standard Deviation | lbs | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Insufficient participation in 6 month surveys to calculate degree of significance for outcome measures.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jana Sacco | University of Florida | 904-244-7418 | Jana.Sacco@jax.ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 16, 2023 | Sep 8, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 20, 2023 | Apr 16, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Standard preoperative weight loss tools | Other | Participants will utilize current standard preoperative weight loss tools. |
|
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.
| at baseline |
| 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. | 6 months |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index | Mean | Full Range | kg/m^2 |
|
|
|
| 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) | 3 of the 25 virtual coach participants completed the 6 month survey | Posted | Mean | Full Range | number of interactions | 6 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | at baseline |
|
|
|
| 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. | Insufficient participation in 6 month survey to calculate degree of significance for outcome measure. | Posted | Number | score on a scale | 6 months |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | 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. | 0 | 4 | 0 | 4 | 0 | 4 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |