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Search / Trial NCT06882200

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 April 23, 2025

Completed

Keywords

Obesity Mindfulness Diving Exercise

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.

Locations

Montpellier, , France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported