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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity and Overweight
• Intervention / Treatment: Other: A combined mindfulness and therapeutic scuba-diving protocol; Other: Control group regular follow up in primary care

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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34080
    • BathysMed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diving group; The program included ten scuba-diving sessions with mindfulness training, twice a week for five weeks, alongside standard care for obesity in a primary care centre in Montpellier	Other: A combined mindfulness and therapeutic scuba-diving protocol; The 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.; Other Names: BathysMed Diving protocol
Placebo Comparator: Control group; Standard care included 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.	Other: Control group regular follow up in primary care; Standard 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.; Other Names: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DEBQ-EE	The primary outcome was the mean change in the emotional eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ-EE) at the end of the two-month protocol.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DEBQ-EE at 5 and 8 months follow up	emotional eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ-EE) at 5 and 8 months follow up	5 and 8 months follow up
DEBQ-RE	Change in the Restrictive eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ-EE) between baseline and two, five and eight months follow up	2, 5 and 8 months follow up
DEBQ-ExtE	Change in the external eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ-EE) between baseline two, five and eight months follow up	2, 5 and 8 months follow up
WSSQ	Change in weight bias internalisation (WBI) and weight self-stigma using the Weight Self Stigma Questionnaire (WSSQ), score between baseline and 2, 5 and 8 months follow up	2, 5 and 8 months follow up
EQVOD scale	Change in the quality of life using a specific questionnaire for obese patients EQVOD (l'échelle de Qualité de Vie Obésité et Diététique) (17); between baseline and 2 , 5 and 8 months follow up	2, 5 and 8 months follow up
PSS Score	Evaluation of Perceived Stress Scale of Cohen score (PSS), between baseline and 2, 5 and 8 months follow up	2, 5 and 8 months follow up
Weight (kg)	Weight measured in Kg	2, 5 and 8 months follow up
BMI kg/m2	BMI kg/m2 Body Mass Index	2, 5 and 8 months follow up
Waist circumference	Waist circumference (cm)	2, 5 and 8 months follow up

Collaborators and Investigators

• Sponsor: BATHYSMED

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: March 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: exercise; obesity; mindfulness; diving
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight
• Other Study ID Numbers: BTY-2022-05-OBEDIVE; 4021591/1 (Other Grant/Funding Number: BPI France)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No