ObesityNCT05797974
Does a Virtual Coach Offer a Better Solution for Weight Reduction in Ventral Hernia Patients With Obesity?
A study testing MyChart enabled virtual weight loss coach and Standard preoperative weight loss tools in people with Obesity and Ventral Hernia, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Ventral Hernia
- What is being tested?
- MyChart enabled virtual weight loss coach and Standard preoperative weight loss tools
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Jacksonville
Jacksonville, Florida, 32209
About this study
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
- Being tested
- MyChart enabled virtual weight loss coach, Standard preoperative weight loss tools
- Medical subject headings
- Obesity, Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyChart enabled virtual weight loss coachOther
MyChart-enabled virtual coach utilized to aid in preoperative weight loss.
Standard preoperative weight loss toolsOther
Participants will utilize current standard preoperative weight loss tools.
| Study group | Role | What they receive |
|---|---|---|
| Virtual coach | Experimental | Participants will utilize the MyChart enabled virtual coach to aid preoperative weight loss. Receives: Other: MyChart enabled virtual weight loss coach |
| 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. Receives: Other: Standard preoperative weight loss tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pounds of Weight Change Per Group
Average net amount of weight change
Measured: 6 months
Secondary outcomes (3)
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)
Measured: 6 months
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start15 Feb 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Jana Sacco, MD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797974
- Sponsor's protocol ID
- 202300391
- Other IDs
- UL1TR001427
- Status last verified
- Apr 2025
- First submitted
- 16 Mar 2023
- Last updated
- 20 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Virtual Coach Offer a Better Solution for Weight Reduction in Ventral Hernia Patients With Obesity?
- ClinicalTrials.gov ID
- NCT05797974
- Acronym / sponsor ID
- 202300391
- Conditions
- Obesity, Ventral Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 4 Apr 2023 (actual)
- Results
- Posted 20 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual coach | Experimental | Other: MyChart enabled virtual weight loss coachParticipants will utilize the MyChart enabled virtual coach to aid preoperative weight loss. |
| Standard weight loss tools | Active comparator | Other: Standard preoperative weight loss toolsParticipants will not utilize the MyChart enabled virtual coach to aid preoperative weight loss, but instead use standard weight loss tools. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyChart enabled virtual weight loss coachMyChart-enabled virtual coach utilized to aid in preoperative weight loss. | Other | Virtual coach |
| Standard preoperative weight loss toolsParticipants will utilize current standard preoperative weight loss tools. | Other | Standard weight loss tools |
Primary outcome
Pounds of Weight Change Per Group
Time frame: 6 months
Average net amount of weight change
3 secondary outcomes
Number of Interactions
Time frame: 6 months
Degree of Quality of Life
Time frame: at baseline
Degree of Satisfaction With the Virtual Coach
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jana Sacco, MD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyChart enabled virtual weight loss coach and Standard preoperative weight loss tools in people with Obesity and Ventral Hernia, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pounds of Weight Change Per Group (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.