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

NCT06882200 | Completed

• 2 other identifiers: BTY-2022-05-OBEDIVE4021591/1
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Obesity and Overweight

Keywords

obesity; mindfulness; diving; exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• DEBQ-EE at 5 and 8 months follow up

  5 and 8 months follow up

• DEBQ-RE

  2, 5 and 8 months follow up

• DEBQ-ExtE

  2, 5 and 8 months follow up

• WSSQ

  2, 5 and 8 months follow up

• EQVOD scale

  2, 5 and 8 months follow up

Study Arms (2)

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

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.

Other: Control group regular follow up in primary care

Interventions

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.

Also known as: BathysMed Diving protocol

Diving group

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.

Also known as: Control group

Control group

Eligibility Criteria

• Age: Up to 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BATHYSMED: lead

Study Sites (1)

BathysMed

Montpellier, 34080, France

Location

MeSH Terms

Conditions

Obesity; Overweight; Motor Activity

Interventions

Primary Health Care; Control Groups

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Comprehensive Health Care; Patient Care Management; Health Services Administration; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 18, 2025
• Study Start: July 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: April 30, 2023
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)