Clinical Trials Directory

Trials / Completed

CompletedNCT06882200

A Combined Mindfulness-diving Protocol on Emotional Eating in Obese Patients: A Prospective Randomized Study

Benefit of the Bathysmed® Diving Protocol on Emotional Eating in Obese Patients: A Prospective Randomized Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
63 (actual)
Sponsor
BATHYSMED · Industry
Sex
All
Age
60 Years
Healthy volunteers
Not accepted

Summary

The goal of this clinical trial is to learn if a combined minfulness-diving program has an impact on emotional eating in adults with obesity. The main questions it aims to answer are: Does the BathysMed protocol have an impact on emotional eating after the 2 months diving protocol? Researchers will compare the diving program to a control group of adult patients with obesity. Participants will be asked to participate in the combined mindfulness-diving protocol for 2 months, and complete the questionnaires at baseline, 2, 5, and 8 months follow up.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHERA combined mindfulness and therapeutic scuba-diving protocolThe Bathysmed program is a unique scuba diving program that combines scuba immersion with techniques from mindfulness meditation, psychology and sports mental preparation. The program includes 30 different exercises over ten scuba-diving sessions with mindfulness training, twice a week for five weeks.
OTHERControl group regular follow up in primary careStandard care includes regular appointments and health education with their general practitioner and monthly appointments with the dietician and psychotherapist at the primary care centre in Montpellier, France throughout the study. This care includes monthly sessions on diet, exercise and general stress management with a registered dietician.

Timeline

Start date
2022-07-01
Primary completion
2022-11-01
Completion
2023-04-30
First posted
2025-03-18
Last updated
2025-03-18

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT06882200. Inclusion in this directory is not an endorsement.