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

NCT ID: NCT06882200

Last Updated: 2025-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-04-30

Brief Summary

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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

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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

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Obesity and Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

A combined mindfulness and therapeutic scuba-diving protocol

Intervention Type OTHER

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.

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.

Group Type PLACEBO_COMPARATOR

Control group regular follow up in primary care

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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BathysMed Diving protocol Control group

Eligibility Criteria

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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.
Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BATHYSMED

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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BathysMed

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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4021591/1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

BTY-2022-05-OBEDIVE

Identifier Type: -

Identifier Source: org_study_id

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