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Completed

NCT Number: NCT06882200

A Combined Mindfulness-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.

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Key information

Conditions

Obesity and Overweight Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BathysMed

Montpellier, 34080, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

A combined mindfulness and therapeutic scuba-diving protocol

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.

Other names: BathysMed Diving protocol

Control group regular follow up in primary care

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.

Other names: Control group

Primary outcomes

  1. 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.

Secondary outcomes

  1. DEBQ-EE at 5 and 8 months follow up

    Time frame: 5 and 8 months follow up

    emotional eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ-EE) at 5 and 8 months follow up

  2. DEBQ-RE

    Time frame: 2, 5 and 8 months follow up

    Change in the Restrictive eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ-EE) between baseline and two, five and eight months follow up

  3. DEBQ-ExtE

    Time frame: 2, 5 and 8 months follow up

    Change in the external eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ-EE) between baseline two, five and eight months follow up

  4. WSSQ

    Time frame: 2, 5 and 8 months follow up

    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

  5. EQVOD scale

    Time frame: 2, 5 and 8 months follow up

    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

  6. PSS Score

    Time frame: 2, 5 and 8 months follow up

    Evaluation of Perceived Stress Scale of Cohen score (PSS), between baseline and 2, 5 and 8 months follow up

  7. Weight (kg)

    Time frame: 2, 5 and 8 months follow up

    Weight measured in Kg

  8. BMI kg/m2

    Time frame: 2, 5 and 8 months follow up

    BMI kg/m2 Body Mass Index

  9. Waist circumference

    Time frame: 2, 5 and 8 months follow up

    Waist circumference (cm)

Sponsors and collaborators

Lead sponsor

BATHYSMED

Industry

Registry information

Official study title

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

Acronym: OBEDIVE

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Mar 18, 2025
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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