Research 

Innovation in Research

True You is committed to providing safe, effective, non-surgical, outpatient weight loss procedures that deliver surgical-level outcomes. We are also proud to share our dedication to improving endoscopic bariatric therapies and advancing patient-related outcomes through focused, innovative, and groundbreaking research. True You is proud to collaborate and lead innovative research projects to advance the field and ensure patient-centered care while investigating new endoscopic methods and technologies.

Active Research Projects

Purse-String Transoral Outlet Reduction (TORe) plus Frequent Aftercare Results in Significant Weight Loss: Findings from a High-Volume, Community Endoscopic Bariatric Practice

Roux en Y gastric bypass (RYGB) is one of the most effective weight loss therapies, but due to the chronic progressive nature of obesity, nearly one third of patients will experience weight regain. As the highest-volume, non-academic TORe center in the United States, True You Weight Loss has a unique opportunity to evaluate the weight loss and safety outcomes of this procedure in the community setting.

Status and Outcomes

Ablate Weight Study

True You is excited to launch a new Gastric Fundus Ablation plus Endoscopic Sleeve Gastroplasty for Weight Loss (ABLATE WEIGHT) study developed and led by our True You Research Team. Are you interested in ESG and contributing to evidence-based research?

Status and Outcomes

A Multi-Site, Prospective Observational Cohort Research Study of Patients Undergoing Endoscopic Bariatric Therapies at True You Weight Loss (CORE True You)

As the highest-volume Endoscopic Bariatric Therapy (EBT) center in the United States, True You Weight Loss is uniquely positioned to gather observational data surrounding endoscopic weight loss procedures, including weight loss outcomes and weight maintenance, short and long-term safety, and improvement in related medical comorbidities in collaboration with our patients.

Status and Outcomes

Spatz3 Adjustable Balloon – Post Approval Study

The Spatz3 Adjustable Balloon System is the world’s first and only adjustable gastric balloon. The Spatz Balloon was approved by the FDA in October 2021, after demonstrating an 84% success rate and 15% average total body weight loss, results that far exceeded every non-adjustable balloon in non-comparative studies.

Status and Outcomes

Research Team

chris mcgowan
Dr. Christopher McGowan, MD, MSCR, AGAF: Research Director

Dr. McGowan directs the Clinical Research team at True You Weight Loss, bringing nearly 20 years of clinical research expertise and the same passion and energy that he dedicates to his patients’ weight loss outcomes. Dr. McGowan completed a GI Epidemiology fellowship at the University of North Carolina at Chapel Hill, where he earned a Master of Science in Clinical Research from the prestigious Gillings School of Global Public Health. He has authored numerous first-author publications in the leading scientific journals, including: Gastroenterology; Gastrointestinal Endoscopy; Obesity Surgery; Clinical Gastroenterology and Hepatology; Hepatology; Radiology; Endoscopy. Dr. McGowan is excited to contribute to advancing the field of endoscopic weight loss through True You Weight Loss’ innovative research efforts.

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Daniel B. Maselli, MD
Dr. Daniel B. Maselli, MD: Associate Research Director

Dr. Maselli has passion for endoscopic bariatric therapies (EBTs), which includes conducting research to answer pertinent questions about how we can understand, modify, and improve these therapies to achieve better outcomes for our patients. His primary interests for research are the use of EBTs for fatty liver disease and other obesity-associated comorbidities, understanding the physiologic mechanisms of EBTs, defining a patient-tailored approach to EBT options, combination EBT and anti-obesity medications, and the development of novel EBTs. Dr. Maselli's interest in clinical research began while he was a gastroenterology fellow at the Mayo Clinic where he was mentored in the research of EBT, anti-obesity medications, and gastrointestinal motor function. Dr. Maselli also completed Mayo Clinic’s postdoctoral certificate program in clinical research at the Center for Clinical and Translational Science. Dr. Maselli has published widely in both medical textbooks and medical journals and looks forward to continuing to drive the field of EBT forward with novel and cutting-edge research at True You Weight Loss.

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Ashley
Ashley Kucera, MPH: Lead Research Coordinator

Ashley is the Lead Clinical Research Coordinator at True You Weight Loss and earned her Bachelor of Arts in Psychology from the University of Dayton and her Master’s in Public Health from Benedictine University with certification in health education and wellness promotion as well as health management and policy. She has formerly worked as a Project Manager and Research Coordinator in the field of primary care medicine in addition to Alzheimer’s disease physical health intervention studies. Additionally, she has delivered community-based nutrition and physical activity interventions for underserved populations throughout her community. Ashley is excited to combine her passion for nutrition, weight management, and relationship building with clinical research. She is driven to conduct informative and innovative research that improves the lives of patients and contributes to best practices in medicine.

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Areebah Waseem
Areebah Waseem

Areebah earned her Bachelor of Science from the University of Illinois-Urbana Champaign in Interdisciplinary Health Sciences, with a concentration in Health and Diversity and a minor in social work, and now serves as a clinical research coordinator at True You Weight Loss. Before joining the True You team, she worked as a Research Assistant in OBGYN research, as well as a Clinical Research Assistant in a research weight loss program that focused on sustainability and psychosocial determinants of health. Areebah is excited to be involved with bariatric and obesity medicine, and to support her team in the innovative research initiatives at True You Weight Loss!

Chase Wooley
Chase Wooley, Clinical Research Coordinator

Chase earned a Bachelor of Science in Biology at the University of North Carolina at Chapel Hill. As an undergraduate, he fell in love with clinical research while studying prenatal substance abuse and how it relates to baby brain development. He has served as a physical activity coach and health educator while assisting in studies aimed at improving care and outcomes for individuals with osteoarthritis. He has also worked as an EMT, assisted with COVID-19 outreach, and volunteered in projects to raise awareness about health disparities for underserved and low-income populations. Chase is excited to continue pursuing research that is truly impactful and will improve the well-being of patients.

Research Training

ACRP Logo
As a team, True You is committed to conducting ethical, responsible, and patient-centered research in a professional and comfortable setting. That is why our medical professionals including our MDs, RDs, and NPs are certified and have successfully completed training from The Association of Clinical Research Professionals for human research protection.

Frequently Asked Questions

Why should I participate in research?

Clinical research is the primary source of medical and healthcare advancement. By participating in research, patients can actively engage in their own health while helping others. As a voluntary research participant, you are contributing to medical research to help discover better ways to prevent, diagnose, and treat disease.

What is an IRB and why does it matter?

All research involving human subjects requires an Institutional Review Board (IRB). An IRB is an independent body consisting of medical, scientific, and non-scientific members. The purpose of an IRB is to ensure the safety, welfare and the rights of participants are protected. True You conducts research with the IRB oversight of WCG IRB (https://www.wcgirb.com/about/) whose responsibilities include the protection of our patients participating in a clinical trial in addition to the ethical and scientific review of the clinical trial protocol and other study-related documents and procedures. True You is dedicated to protecting our patients while ensuring scientific integrity and complying with local regulations and good clinical practice.

Will my participation in research be kept private?

Yes. Researchers are required by law to keep all information confidential. The primary way by which this is done is to assign a study ID to all study participants so that names or other identifying information is removed for your protection and privacy. Further, access to your private information and your medical record will be maintained in a secure, encrypted, password- protected electronic health record.

What is informed consent?

The informed consent process is an essential part of the protection of research participants. Informed consent is an ongoing conversation and process to help patients decide whether or not to participate in a clinical trial, by understanding their role as a “subject of research”. The informed consent includes an explanation of the research purpose, how the research is conducted, the potential risks and benefits of participating, and the voluntary nature of participation. Documentation of informed consent is obtained by using an WCG IRB approved form that will be signed by the participant and the investigator.

Our informed consent process will include the following:

  • A statement explaining that the study involves research.
  • An explanation of the purposes of the research.
  • The expected length of time for participation.
  • A description of all the procedures that will be completed during enrollment on the clinical trial.
  • Information about all experimental procedures that will be completed during the clinical trial.
  • A description of any reasonably foreseeable risks or discomforts.
  • A description of any benefits to you or to others which may reasonably be expected from the research.
  • A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to you.
  • A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
  • For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
  • An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the participant.
  • A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Source: FDA Gov | Informed Consent

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