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

BATHYSMED63 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Obesity and Overweight

Interventions

A combined mindfulness and therapeutic scuba-diving protocolOTHER

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

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.

Eligibility

Sex: ALLMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

BathysMed

Montpellier, France

Outcomes

Primary Outcomes

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.

Time frame: 2 months

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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