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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

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

Endoscopic Sleeve Gastroplasty in Class III Obesity: Weight Loss and Metabolic Outcomes in 404* Consecutive Patients

The aim of this project was to determine if ESG is a safe and effective option for patients with a BMI of 40+ who are not interested in, or eligible for, traditional bariatric therapy through a retrospective, international, multicenter chart review. This retrospective study evaluated the data of over 400 patients who underwent ESG by one of two experienced bariatric endoscopists (Dr. Christopher McGowan of True You Weight Loss and Dr. Anna Hoff of Angioskope in Sao Paulo, Brazil) between May of 2018 and March of 2022 with class III obesity (BMI 40+).

Status and Outcomes

Perceptions and Characteristics of Patients Pursuing Primary Endoscopic Bariatric Therapies (PERCEBT)

Endoscopic bariatric therapies (EBTs), including the endoscopic sleeve gastroplasty (ESG) and intragastric balloons (IGBs), represent lower-risk yet effective weight loss options for patients not interested in, or eligible for, traditional bariatric surgery. However, there is limited scientific literature addressing the factors associated with receptivity to EBTs in eligible 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

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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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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Research Training

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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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