Trial Outcomes & Findings for Does a Virtual Coach Offer a Better Solution for Weight Reduction in Ventral Hernia Patients With Obesity? (NCT NCT05797974)

NCT ID: NCT05797974

Last Updated: 2025-11-20

Results Overview

Average net amount of weight change

Recruitment status

COMPLETED

Study phase

Target enrollment

32 participants

Primary outcome timeframe

6 months

Results posted on

2025-11-20

Participant Flow

First participant enrolled February 15, 2024 in ambulatory surgical clinic.

Of 33 enrolled participants, 32 met inclusion criteria and were included in study participation.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	28	4
Overall Study COMPLETED	3	1
Overall Study NOT COMPLETED	25	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Virtual Coach n=28 Participants 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.	Standard Weight Loss Tools n=4 Participants 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.	Total n=32 Participants Total of all reporting groups
Age, Continuous	50 years	58 years n=4 Participants	51 years n=8 Participants
Sex: Female, Male Female	22 Participants	1 Participants n=4 Participants	23 Participants n=8 Participants
Sex: Female, Male Male	6 Participants	3 Participants n=4 Participants	9 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	14 Participants	1 Participants n=4 Participants	15 Participants n=8 Participants
Race (NIH/OMB) White	13 Participants	3 Participants n=4 Participants	16 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	0 Participants n=4 Participants	1 Participants n=8 Participants
Body Mass Index	45 kg/m^2	40 kg/m^2 n=4 Participants	44 kg/m^2 n=8 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Intent to treat population (all participants assigned to virtual coach or standard weight loss tool)

Average net amount of weight change

Outcome measures

Outcome measures
Measure	Virtual Coach n=28 Participants 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.	Standard Weight Loss Tools n=4 Participants 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.
Pounds of Weight Change Per Group	24.25 lbs Standard Deviation 9.95	24.25 lbs Standard Deviation 9.95

SECONDARY outcome

Timeframe: 6 months

Population: 3 of the 25 virtual coach participants completed the 6 month survey

number of interactions with virtual coach per subject; interactions were determined as a digital responses logged from participants in the electronic medical record (MyChart)

Outcome measures

Outcome measures
Measure	Virtual Coach n=3 Participants 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.	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.
Number of Interactions	9 number of interactions Interval 0.0 to 10.0	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Virtual Coach n=28 Participants 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.	Standard Weight Loss Tools n=4 Participants 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.
Degree of Quality of Life	46.19 score on a scale Standard Deviation 18.11	46.19 score on a scale Standard Deviation 18.11

SECONDARY outcome

Timeframe: 6 months

Population: Insufficient participation in 6 month survey to calculate degree of significance for outcome measure.

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.

Outcome measures

Outcome measures
Measure	Virtual Coach n=1 Participants 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.	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.
Degree of Satisfaction With the Virtual Coach	3 score on a scale	—

Adverse Events

Virtual Coach

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Weight Loss Tools

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jana Sacco

University of Florida

Phone: 904-244-7418

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place