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

BATHYSMED

Status: Completed

Conditions: Obesity and Overweight

Treatments: Other: A combined mindfulness and therapeutic scuba-diving protocol; Other: Control group regular follow up in primary care

Study type: Interventional

Funder types: Industry

Identifiers

NCT06882200

BTY-2022-05-OBEDIVE

4021591/1 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: All

Ages: Under 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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63 participants in 2 patient groups, including a placebo group

Diving group

Experimental group

Description:

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

Treatment:

Other: A combined mindfulness and therapeutic scuba-diving protocol

Control group

Placebo Comparator group

Description:

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.

Treatment:

Other: Control group regular follow up in primary care