Clinical trial NCT06157411: Adapting Mindful Eating Program for French Overweight/Obese Population
Official title: Validation of a Mindful Eating Program Adapted to the French Population Living With Overweight or Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Mindful eating
Mindfulness
Validation program
Mixed methods
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Variation in the level of mindful eating.
timeFrame: Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
Secondary outcomes:
measure: Variation in anxiety and depression levels.
timeFrame: Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
measure: Variation in the level of intuitive eating.
timeFrame: Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
measure: Variation in the level of compulsive eating.
timeFrame: Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
measure: Variation in the level of mindfulness.
timeFrame: Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
measure: Variation in eating behavior.
timeFrame: Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
measure: Variation in physical activity levels.
timeFrame: Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
measure: Variation in stress levels.
timeFrame: Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
measure: Gross weight loss (kg)
timeFrame: Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
Other outcomes:
measure: Impact of the program on participants' lives
timeFrame: 3 months and 3 weeks after the end of the program
Locations:
city: Montpellier
country: France
facility: Antoine Avignon
Study officials:
affiliation: University Hospital, Montpellier
name: Antoine Avignon, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: