Virtual Coach for Weight Loss in Ventral Hernia Patients

Overseen By Jennifer Mull, MSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Psychiatric medications, Steroids

Disqualifiers: Pregnancy, Severe mental disorders, Substance use disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

33 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on psychiatric medications associated with weight gain or long-term steroid therapy, you may not be eligible to participate.

What data supports the effectiveness of the treatment MyChart enabled virtual weight loss coach for weight loss in ventral hernia patients?

Research shows that web-based weight loss programs can lead to significant weight loss and health improvements, such as reduced abdominal fat and better metabolic health. Additionally, eHealth interventions, which include online and digital tools, have been found to be as effective as traditional methods for weight loss, suggesting that virtual coaching could be a promising approach for managing weight before surgery. ^{1 2 3 4 5}

Is the Virtual Coach for Weight Loss safe for humans?

The research on web-based weight loss programs, which are similar to the Virtual Coach for Weight Loss, suggests they are generally safe for humans. These programs have been used successfully in various studies without any reported safety concerns. ^{1 3 5 6 7}

How is the MyChart-enabled Virtual Coach treatment unique for weight loss in ventral hernia patients?

The MyChart-enabled Virtual Coach is unique because it uses an online platform to provide personalized feedback and self-monitoring tools, which have been shown to be effective in weight loss programs. Unlike traditional methods, this virtual approach offers continuous support and motivation through digital progress tracking and potentially social support, making it accessible and engaging for patients. ^{4 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Jana Sacco, MD

Principal Investigator

Assistant Professor

Eligibility Criteria

This trial is for adults aged 18-90 with obesity (BMI of 30+) who are planning to have elective ventral hernia repair surgery. They must be diagnosed with Obesity (ICD Code: E66.9) and have a complete medical record for statistical analysis.

Inclusion Criteria

I am 18-90 years old, with a BMI over 30, diagnosed with obesity, and scheduled for elective ventral hernia repair.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Weight Loss

Participants utilize either a MyChart-enabled virtual coach or standard weight loss tools to aid preoperative weight loss

6 months

Regular virtual interactions with the coach

Follow-up

Participants are monitored for weight change, quality of life, and satisfaction with the virtual coach

4 weeks

Treatment Details

Interventions

• MyChart enabled virtual weight loss coach
• Standard preoperative weight loss tools

Trial Overview The study is testing if a MyChart-enabled virtual weight loss coach can help obese patients lose more weight before ventral hernia surgery compared to standard preoperative tools, potentially reducing hospital readmissions.

Participant Groups

Group I: Virtual coach Experimental Treatment 1 Intervention

Participants will utilize the MyChart enabled virtual coach to aid preoperative weight loss.

Group II: Standard weight loss tools Active Control 1 Intervention

Participants will not utilize the MyChart enabled virtual coach to aid preoperative weight loss, but instead use standard weight loss tools.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Findings from Research

eHealth-delivered interventions for adults undergoing bariatric surgery can be as effective as traditional methods for weight loss, with 14 studies involving 1633 participants showing significant improvements in weight loss and eating psychopathology.

While both eHealth and control groups experienced weight loss, long-term weight maintenance was a challenge for both, indicating that ongoing support is necessary for sustained results after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are eHealth interventions for adults who are scheduled for or have undergone bariatric surgery as effective as usual care? A systematic review. Wright, C., Mutsekwa, RN., Hamilton, K., et al.[2022]

Automated digital interventions (ADIs) can significantly enhance weight loss outcomes when used alongside human coaching, with a mean weight change difference of 2.18 kg observed in a meta-analysis of 13 studies involving 1,471 participants.

The effectiveness of ADIs appears to be greater when the frequency or duration of human coaching is lower, suggesting that ADIs can provide valuable support in less intensive coaching scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incorporating automated digital interventions into coach-delivered weight loss treatment: A meta-analysis. Berry, MP., Sala, M., Abber, SR., et al.[2021]

A web-based weight loss program requiring only 2 personal interviews over 6 months led to a significant average weight loss of 2.7% among 20 obese participants, indicating its efficacy as a low-resource intervention.

Participants also experienced a notable 12.6% reduction in abdominal visceral fat and improvements in liver enzyme levels, suggesting additional health benefits beyond weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of a web-based weight loss program with auto-extraction of behavioural objectives and recording of daily weight and steps in pre-obese outpatients. Matsumoto, Y., Yoshiuchi, S., Miyauchi, T., et al.[2018]

A smartphone application designed to encourage physical activity showed a significant increase in moderate-to-vigorous physical activity (MVPA) among 146 bariatric surgery patients at 18 weeks, compared to a control group that decreased their activity levels.

While the intervention group maintained a similar body mass index (BMI) compared to the control group, the control group experienced a greater reduction in BMI, indicating that the app may help with short-term activity but not necessarily with long-term weight loss or inactivity reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Smartphone Application on Physical Activity and Weight Loss After Bariatric Surgery-Results from a Randomized Controlled Trial. Bonn, SE., Hult, M., Spetz, K., et al.[2023]

In a study of 4,132 individuals using an online weight loss forum, the use of past-tense verbs and motion words was linked to lower weekly weights, suggesting that reflecting on past successes may aid weight loss.

Conversely, higher usage of conjunctions and exclusion words was associated with increased weight, indicating that certain communication styles may hinder weight loss efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the relationship between changes in weight and utterances in an online weight loss forum: a content and correlational analysis study. Hekler, EB., Dubey, G., McDonald, DW., et al.[2018]

In a study of 1298 participants, both computer- and human-delivered personalized feedback in web-based behavior change programs resulted in greater weight loss compared to a nonpersonalized intervention over 24 weeks, with mean weight losses of -1.08 kg and -1.57 kg respectively.

The group receiving human-delivered feedback from a dietitian showed higher engagement and a significantly greater chance of achieving clinically meaningful weight loss (≥5%), highlighting the importance of personalized coaching in dietary interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized Web-Based Weight Loss Behavior Change Program With and Without Dietitian Online Coaching for Adults With Overweight and Obesity: Randomized Controlled Trial. Beleigoli, A., Andrade, AQ., Diniz, MF., et al.[2021]

In a 12-month online weight control program with 123 participants, the use of feedback features like progress charts and journals was the strongest predictor of weight loss in the first 6 months.

For maintaining weight loss, social support features such as web chats and participant connections were most effective, highlighting the importance of both feedback and community in successful weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based weight control: the relationship between web features and weight loss. Krukowski, RA., Harvey-Berino, J., Ashikaga, T., et al.[2018]

A study of 479 KiloCoach users over 6 months showed that those who lost more weight early on (weeks 3-4) were more likely to achieve greater overall weight loss, with the high success group losing an average of 14.2% of their initial weight.

Close adherence to the program, such as following dietary protocols and regularly entering weight, significantly predicted better weight loss outcomes, highlighting the importance of consistent engagement with the weight loss program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determinants of successful weight loss after using a commercial web-based weight reduction program for six months: cohort study. Postrach, E., Aspalter, R., Elbelt, U., et al.[2022]

Engagement with self-monitoring tools, such as online diet and exercise diaries, and participation in social support forums are significantly associated with weight loss in a study of 3621 participants in an online weight control program.

Higher engagement levels, particularly with food diaries, were linked to achieving clinically significant weight loss (over 5%), with men showing a 3.45 times and women a 5.05 times greater likelihood of success compared to those with lower engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between weight loss and engagement with a web-based food and exercise diary in a commercial weight loss programme: a retrospective analysis. Johnson, F., Wardle, J.[2022]

In a 12-week study involving 112 overweight Japanese adults, those receiving professional dietary coaching via a smartphone app lost significantly more weight (average -1.4 kg) compared to the control group (-0.1 kg).

Participants who frequently uploaded meal photos to the group chat not only lost more weight but also showed significant improvements in cardiometabolic risk factors, indicating that active engagement in the program enhances health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Professional dietary coaching within a group chat using a smartphone application for weight loss: a randomized controlled trial. Tanaka, K., Sasai, H., Wakaba, K., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Are eHealth interventions for adults who are scheduled for or have undergone bariatric surgery as effective as usual care? A systematic review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Incorporating automated digital interventions into coach-delivered weight loss treatment: A meta-analysis. [2021]

3. China pubmed.ncbi.nlm.nih.gov

Utility of a web-based weight loss program with auto-extraction of behavioural objectives and recording of daily weight and steps in pre-obese outpatients. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of a Smartphone Application on Physical Activity and Weight Loss After Bariatric Surgery-Results from a Randomized Controlled Trial. [2023]

5. Canada pubmed.ncbi.nlm.nih.gov

Exploring the relationship between changes in weight and utterances in an online weight loss forum: a content and correlational analysis study. [2018]

6. Canada pubmed.ncbi.nlm.nih.gov

Personalized Web-Based Weight Loss Behavior Change Program With and Without Dietitian Online Coaching for Adults With Overweight and Obesity: Randomized Controlled Trial. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Internet-based weight control: the relationship between web features and weight loss. [2018]

8. Canada pubmed.ncbi.nlm.nih.gov

Determinants of successful weight loss after using a commercial web-based weight reduction program for six months: cohort study. [2022]

9. England pubmed.ncbi.nlm.nih.gov

The association between weight loss and engagement with a web-based food and exercise diary in a commercial weight loss programme: a retrospective analysis. [2022]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Professional dietary coaching within a group chat using a smartphone application for weight loss: a randomized controlled trial. [2022]