Adapting Mindful Eating Program for French Overweight/Obese Population (MIND-EAT)

University Hospital Center (CHU)

Status: Completed

Conditions: Overweight and Obesity

Treatments: Behavioral: Conventional Dietetic Intervention (DC group); Behavioral: Mindful Eating Intervention (AC group)

Study type: Interventional

Funder types: Other

Identifiers

NCT06157411

RECHMPL22_0210

Details and patient eligibility

About

The aim of this project is to validate a new mindful eating programme adapted to the overweight or obese French population. Recognising the importance of diet in the management of chronic diseases, particularly obesity, and the limitations of traditional weight management approaches, the study focuses on the application of mindful eating. The investigators have adapted a model based on an existing eating disorders programme overseas, taking into account feedback from participants in a qualitative study and the scientific literature. The ultimate aim is to test and validate the effectiveness of this new programme in improving the care of overweight or obese French adults, thereby filling a gap in interventions for this population in France.

Full description

This research will take the form of a single-center, randomized, two-arm trial comparing a mindful eating intervention (AC group) with a conventional dietary intervention (DC group). The investigators plan to enroll 56 patients who will be randomized to these two groups with stratification based on gender, age (<45, >=45), and BMI (25-30, >30). Randomization will be performed by minimization.

Participants in the AC group (N=28) will follow a program led by an instructor trained in nutrition and mindfulness, incorporating the Alberts program adapted for the overweight or obese population. For 8 consecutive weeks, comprising one 2-hour group session per week at Montpellier University Hospital and individual exercises at home.

Participants in the DC group (N=28) will follow the standard weight management program normally offered by the Nutrition - Diabetes Unit of the Montpellier University Hospital.

This research also includes a qualitative study for the AC group, based on focus groups set up after the end of the mindful eating program.

Participants will be recruited from all consecutive overweight or obese patients attending the Nutrition and Diabetes Unit of the University Hospital of Montpellier who have not yet been enrolled in the therapeutic education program. The unit sees over 1,000 patients a year who meet the criteria for this study.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• First visit to the Nutrition and Diabetes Unit of Montpellier University Hospital for overweight/obesity
• Adults aged 18 and over, volunteers
• BMI ≥ 25kg/m² and ≤ 50kg/m²
• Provisional verbal consent followed by signed written consent

Exclusion criteria

• People who are illiterate or suffer from a major cognitive impairment that prevents them from understanding the study and the mindful eating program
• Pregnant or breast-feeding women
• People who are taking medicines that may have an effect on their weight (especially GLP-1 analogs, neuroleptics, corticosteroids)
• Anyone with a history of bariatric surgery or scheduled bariatric surgery within the next 6 months
• Presence of co-morbidities or severe pathologies (in particular respiratory failure, heart failure, cancer)
• Diagnosis of severe psychiatric disorder (in particular schizophrenia, bipolar disorder), depressive syndrome, or suicidal behavior in the past year
• People suffering from genetic or syndromic obesity
• Lack of Internet access
• Person currently participating in another interventional study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Mindful Eating Intervention (AC group)

Experimental group

Description:

* Mindful eating program: Two sub-groups of 14 participants will follow the program for 8 consecutive weeks. * Follow-up group session: The two groups of 14 participants will each attend a follow-up group session. * 3 visits with a doctor: The 28 participants will have a pre-intervention visit, a post-intervention visit, and a final visit 3 months after the program. * Focus groups: The two groups of 14 participants will be divided into two (N=7, x4) for a focus group session.

Treatment:

Behavioral: Mindful Eating Intervention (AC group)

Conventional Dietetic Intervention (DC group)

Active Comparator group

Description:

* Therapeutic education program (ETP): The 28 participants will follow the ETP program "Obesity: living better, balancing my weight". * Follow-up group session: The 28 participants will have an individual follow-up session in the form of a final Shared Educational Assessment. * 3 visits with a doctor: The 28 participants will have a pre-intervention visit, a post-intervention visit, and a final visit 3 months after the program.

Treatment:

Behavioral: Conventional Dietetic Intervention (DC group)