Obesity and Overweight
Conditions
Keywords
obesity, mindfulness, diving, exercise
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.
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.
Interventions
OTHERA combined mindfulness and therapeutic scuba-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.
OTHERControl group regular follow up in primary care
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.
Sponsors
BATHYSMED
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DEBQ-EE | 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
| Measure | Time frame | Description |
|---|---|---|
| DEBQ-RE | 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 |
| DEBQ-ExtE | 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 |
| WSSQ | 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 |
| EQVOD scale | 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 |
| DEBQ-EE at 5 and 8 months follow up | 5 and 8 months follow up | emotional eating subscale of the Dutch Eating Behaviour Questionnaire (DEBQ-EE) at 5 and 8 months follow up |
| Weight (kg) | 2, 5 and 8 months follow up | Weight measured in Kg |
| BMI kg/m2 | 2, 5 and 8 months follow up | BMI kg/m2 Body Mass Index |
| Waist circumference | 2, 5 and 8 months follow up | Waist circumference (cm) |
| PSS Score | 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 |
Countries
France
Outcome results
None listed