A Combined Mindfulness-diving Protocol on Emotional Eating in Obese Patients: a Prospective Randomized Study
Launched by BATHYSMED · Mar 12, 2025
Trial Information
Current as of May 09, 2025
Completed
Keywords
ClinConnect Summary
This unblinded randomized controlled trial is performed in the community setting, Montpellier, France. Adults with a BMI \> 30kg/m2 were randomly assigned (1:1) to a Bathysmed® 2-month program (intervention group) therapeutic scuba-diving protocol with mindfulness exercises plus standard care, or stand-alone standard care including dietary and psychological support (control group). The primary outcome was the mean change in the emotional eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ-EE) at 2-months as intention to treat.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • patients with obesity (Body Mass Index BMI \> 30kg/m2),
- • adults over the age of 18 able to provide written consent
- • affiliated to public medical insurance.
- Exclusion Criteria:
- • BMI \> 45 kg/m2,
- • older than 60 years,
- • unable to walk,
- • known psychiatric pathology apart from anxiety and depression,
- • intellectual deficit,
- • routinely practising meditation,
- • a known contra-indication to scuba-diving
- • known past medical history of cardiac problems.
About Bathysmed
Bathysmed is a leading clinical trial sponsor dedicated to advancing innovative medical solutions through rigorous research and development. With a focus on enhancing patient outcomes, Bathysmed collaborates with healthcare professionals and regulatory bodies to design and execute high-quality clinical trials across various therapeutic areas. Our commitment to scientific integrity and patient safety drives our mission to bring cutting-edge treatments to market, ensuring they meet the highest standards of efficacy and safety. Through strategic partnerships and a robust operational framework, Bathysmed aims to contribute significantly to the future of healthcare.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Montpellier, , France
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported