Obesity and OverweightOBEDIVENCT06882200
A Combined Mindfulness-diving Protocol on Emotional Eating in Obese Patients: A Prospective Randomized Study
A study testing A combined mindfulness and therapeutic scuba-diving protocol in people with Obesity and Overweight, run by BATHYSMED at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 60 years
- Conditions the study is for
- Obesity and Overweight
- What is being tested?
- A combined mindfulness and therapeutic scuba-diving protocol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2022to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Obesity and Overweight
- Being tested
- A combined mindfulness and therapeutic scuba-diving protocol, Control group regular follow up in primary care
- Keywords
- obesity, mindfulness, diving, exercise
- Medical subject headings
- Obesity, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A combined mindfulness and therapeutic scuba-diving protocolOther
Also called BathysMed 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.
Control group regular follow up in primary careOther
Also called Control group
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.
| Study group | Role | What they receive |
|---|---|---|
| Diving group | Experimental | 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 Receives: Other: A combined mindfulness and therapeutic scuba-diving protocol |
| Control group | Placebo comparator | 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. Receives: Other: Control group regular follow up in primary care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (9)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 2, 5 and 8 months follow up
Weight (kg)
Weight measured in Kg
Measured: 2, 5 and 8 months follow up
BMI kg/m2
BMI kg/m2 Body Mass Index
Measured: 2, 5 and 8 months follow up
Waist circumference
Waist circumference (cm)
Measured: 2, 5 and 8 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start1 Jul 2022
- Primary completion1 Nov 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- BATHYSMED
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882200
- Sponsor's protocol ID
- BTY-2022-05-OBEDIVE
- Other IDs
- 4021591/1
- Acronym
- OBEDIVE
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Griffiths K, Markarian T, Meurice V, Muzellec M, Lannoy F, Beneton F, Michelet P. Efficacy of a combined diving and mindfulness program on emotional eating in adults with obesity: Randomised controlled trial with standard care. PLoS One. 2026 Mar 27;21(3):e0345784. doi: 10.1371/journal.pone.0345784. eCollection 2026.
PubMed 41894522
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of the Bathysmed® Diving Protocol on Emotional Eating in Obese Patients: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT06882200
- Acronym / sponsor ID
- OBEDIVE / BTY-2022-05-OBEDIVE
- Conditions
- Obesity and Overweight
- Keywords
- obesity, mindfulness, diving, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- BATHYSMEDIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diving group | Experimental | Other: A combined mindfulness and therapeutic scuba-diving protocolThe 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 |
| Control group | Placebo comparator | Other: Control group regular follow up in primary careStandard 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. |
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- BMI > 45 kg/m2,
- older than 60 years,
- unable to walk,
- known psychiatric pathology apart from anxiety and depression,
- intellectual deficit,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A combined mindfulness and therapeutic scuba-diving protocolAlso: BathysMed 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. | Other | Diving group |
| Control group regular follow up in primary careAlso: Control groupStandard 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 | Control group |
Primary outcome
DEBQ-EE
Time frame: 2 months
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.
9 secondary outcomes
DEBQ-EE at 5 and 8 months follow up
Time frame: 5 and 8 months follow up
DEBQ-RE
Time frame: 2, 5 and 8 months follow up
DEBQ-ExtE
Time frame: 2, 5 and 8 months follow up
WSSQ
Time frame: 2, 5 and 8 months follow up
EQVOD scale
Time frame: 2, 5 and 8 months follow up
PSS Score
Time frame: 2, 5 and 8 months follow up
Weight (kg)
Time frame: 2, 5 and 8 months follow up
BMI kg/m2
Time frame: 2, 5 and 8 months follow up
Waist circumference
Time frame: 2, 5 and 8 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Derived from this study: PubMed 41894522Griffiths K, Markarian T, Meurice V, Muzellec M, Lannoy F, Beneton F, Michelet P. Efficacy of a combined diving and mindfulness program on emotional eating in adults with obesity: Randomised controlled trial with standard care. PLoS One. 2026 Mar 27;21(3):e0345784. doi: 10.1371/journal.pone.0345784. eCollection 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A combined mindfulness and therapeutic scuba-diving protocol in people with Obesity and Overweight, run by BATHYSMED at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DEBQ-EE (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06882200, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.