Virtual Coach for Weight Loss in Ventral Hernia Patients
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Florida
Must not be taking: Psychiatric medications, Steroids
Disqualifiers: Pregnancy, Severe mental disorders, Substance use disorder, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
13567How 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.
478910Eligibility 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.
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Virtual coachExperimental Treatment1 Intervention
Participants will utilize the MyChart enabled virtual coach to aid preoperative weight loss.
Group II: Standard weight loss toolsActive Control1 Intervention
Participants will not utilize the MyChart enabled virtual coach to aid preoperative weight loss, but instead use standard weight loss tools.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Florida JacksonvilleJacksonville, FL
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Who Is Running the Clinical Trial?
University of FloridaLead Sponsor
National Center for Advancing Translational Sciences (NCATS)Collaborator
References
Are eHealth interventions for adults who are scheduled for or have undergone bariatric surgery as effective as usual care? A systematic review. [2022]This systematic review aimed to evaluate the effect of eHealth-delivered interventions for adults who undergo bariatric surgery on postoperative weight loss, weight loss maintenance, eating psychopathology, quality of life, depression screening, and self-efficacy. Six electronic databases were searched, with 14 studies (across 17 reports) included, involving 1633 participants. With substantial heterogeneity, qualitative descriptions have been provided. Interventions were delivered via an online program or internet modules (n = 2), telephone (n = 2), text messages (n = 2), videoconferencing (n = 3), mobile application (n = 1), and audiovisual media (n = 1). Three studies included a combination, including internet modules and telephone (n = 1), wireless fidelity scales, emails, and telephone (n = 1), and a combination of online treatment, weekly emails, and access to a private Facebook group (n = 1). All the eHealth interventions, except for one, implemented behavior change techniques, including self-monitoring, problem solving, social support, goal setting, and shaping knowledge. Both eHealth intervention and control groups lost weight across the included studies, and eHealth was found to be as effective as or more effective than the control for weight loss. Two studies measured weight loss maintenance; both eHealth and control groups regained weight in the longer term. The interventions showed significant improvement on assessment measures for eating psychopathology. In conclusion, when bariatric surgery patients have limited or no access to healthcare teams or require additional support, eHealth may be a suitable option. Future studies implementing eHealth interventions would benefit from reporting intervention components as per the behavior change techniques taxonomy and further consideration of delivering eHealth in a stepped care approach would be beneficial.
Incorporating automated digital interventions into coach-delivered weight loss treatment: A meta-analysis. [2021]Automated digital interventions (ADIs) represent a potentially promising approach to enhance the outcomes of human coach-delivered weight loss interventions. However, the extent to which ADIs provide additive benefit is unclear. This study represents the first systematic review and meta-analysis of the effectiveness of ADIs for improving the outcomes of human coach-delivered weight loss treatment.
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]The epidemic of obesity is now a major public health concern in many parts of the world. Face-to-face tailored lifestyle modification therapy is one of the major approaches used for weight loss. However, the lack of time for multiple visits and the lack of resources for administering therapy hinder its implementation. We administered a web-based weight loss program for obese patients from July 2010 to January 2012 that required only 2 personal interviews over 6 months. The program used a system of auto-extraction of behavioural objectives and auto recording of daily weight and number of steps taken. The subjects included 3 obese men (mean age, 35.7 ± 2.3 years; mean body mass index (BMI), 30.4 ± 0.8 kg/m²) and 17 obese women (mean age, 39.3 ± 9.5 years; mean BMI, 28.1 ± 1.8 kg/m2) who volunteered to participate in this weight loss program. Weight loss achieved through this program was significant (mean, 2.7%, p=0.047). Abdominal visceral fat area (VFA) decreased significantly (mean, 12.6%, p=0.017), and the serum cholinesterase and alanine aminotransferase levels improved (mean, 33 U/L, p=0.003; mean, 7 IU/L, p=0.033 respectively). Metabolic syndrome criteria number had a tendency to decrease. Dietary and nutrient intake levels on the food frequency questionnaire improved. Weight loss ratio after 6 months and initial weight loss ratio were strongly significantly correlated. A web-based weight loss program with auto-extraction of behavioural objectives and recording of daily weight and steps can achieve weight loss, as determined by VFA reduction, on low manpower.
Effect of a Smartphone Application on Physical Activity and Weight Loss After Bariatric Surgery-Results from a Randomized Controlled Trial. [2023]Ways to motivate and support patients in being physically active after bariatric surgery are needed. This trial was aimed at evaluating the effect of using a smartphone application targeting physical activity during 12 weeks on moderate-to-vigorous physical activity (MVPA, primary outcome) and secondary outcomes of inactivity, light physical activity (LPA), body mass index (BMI), and percent total weight loss (%TWL) after bariatric surgery.
Exploring the relationship between changes in weight and utterances in an online weight loss forum: a content and correlational analysis study. [2018]There is increasing interest in the use of online forums as a component of eHealth weight loss interventions. Although the research is mixed on the utility of online forums in general, results suggest that there is promise to this, particularly if the systems can be designed well to support healthful interactions that foster weight loss and continued engagement.
Personalized Web-Based Weight Loss Behavior Change Program With and Without Dietitian Online Coaching for Adults With Overweight and Obesity: Randomized Controlled Trial. [2021]The effect of computer- or human-delivered personalized feedback on the effectivess of web-based behavior change platforms for weight loss is unclear.
Internet-based weight control: the relationship between web features and weight loss. [2018]Internet-based weight control programs have been showing promising results; however, as of yet, it is unclear which website components are critical for producing and maintaining weight loss. The aim of this study is to examine the utilization patterns of a weight control website and the relationship of the Web features to weight loss and maintenance. One hundred and twenty three (N = 123) participants took part in a 12-month behavioral weight control program over the Internet and their website utilization patterns were monitored. When examining the clustering of Web feature utilization and weight loss, the "feedback" factor (progress charts, physiological calculators, and past journals) was the best predictor of weight loss during the treatment period (baseline to 6 months), while the "social support" factor (Web chats and biographical information/e-mail addresses of participants) was the best predictor during maintenance. Weight loss in an online weight control program was related to dynamic Web features that provided feedback, support, and motivation to participants.
Determinants of successful weight loss after using a commercial web-based weight reduction program for six months: cohort study. [2022]The Internet is widely available and commonly used for health information; therefore, Web-based weight loss programs could provide support to large parts of the population in self-guided weight loss. Previous studies showed that Web-based weight loss interventions can be effective, depending on the quality of the program. The most effective program tools are visual progress charts or tools for the self-monitoring of weight, diet, and exercises. KiloCoach, a commercial program currently available in German-speaking countries, incorporates these features. A previous investigation showed that the program effectively supports users in losing weight.
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]The Internet provides a widely accessible platform for weight loss interventions. Automated tools can allow self-guided monitoring of food intake and other target behaviours that are established correlates of weight change. Many programmes also offer social support from the virtual community. The aim of this research was to assess associations between engagement with self-monitoring tools and social support, and weight loss in an online weight-control programme.
Professional dietary coaching within a group chat using a smartphone application for weight loss: a randomized controlled trial. [2022]To test the effectiveness of professional dietary coaching via group chat using a smartphone application (app) for weight loss.