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

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06157411

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity	Behavioral: Mindful Eating Intervention (AC group) Behavioral: Conventional Dietetic Intervention (DC group)	N/A

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, integrating the Alberts program adapted for the overweight or obese population. For reasons of practical feasibility in carrying out the mindful eating sessions, the participants will be divided into two sub-groups of 14 participants each for 8 consecutive weeks, comprising one 2-hour group session per week at the University Hospital of Montpellier 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Validation of a Mindful Eating Program Adapted to the French Population Living With Overweight or Obesity

Anticipated Study Start Date :

Dec 17, 2023

Anticipated Primary Completion Date :

Jun 16, 2024

Anticipated Study Completion Date :

Jun 17, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mindful Eating Intervention (AC group) 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.	Behavioral: Mindful Eating Intervention (AC group) Screening visit: Patients will meet with a doctor, a dietician, a teacher of adapted physical activity or a psychologist. Visit 0: Following 24 to 72 hours of reflection, the investigator will confirm the patient's understanding of the study, and those expressing verbal willingness will be randomized into the two groups. Visit 1: Participants will be weighed and required to fill out eight questionnaires on a secure platform. Mindful eating program: group sessions one evening a week (8x2h) and home exercises (30 min/day). Visit 2: visit identical to visit 1 Follow-up group session: To assess each person's progress according to their needs, resources, difficulties, life plans, and initial expectations. Visit 3: visit identical to visit 1 Focus groups: Each participant will be asked to describe the program and talk about their perceptions and feelings, as well as the potential changes in behavior they have observed in their daily life.
Active Comparator: Conventional Dietetic Intervention (DC group) 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.	Behavioral: Conventional Dietetic Intervention (DC group) Screening visit: Patients will meet with a doctor, a dietician, a teacher of adapted physical activity or a psychologist. Visit 0: Following 24 to 72 hours of reflection, the investigator will confirm the patient's understanding of the study, and those expressing verbal willingness will be randomized into the two groups. Visit 1: Participants will be weighed and required to fill out eight questionnaires on a secure platform. Visit 2: visit identical to visit 1 Follow-up group session: To assess each person's progress according to their needs, resources, difficulties, life plans, and initial expectations. Visit 3: visit identical to visit 1

Arm

Intervention/Treatment

Experimental: Mindful Eating Intervention (AC group)

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.

Behavioral: Mindful Eating Intervention (AC group)

Screening visit: Patients will meet with a doctor, a dietician, a teacher of adapted physical activity or a psychologist. Visit 0: Following 24 to 72 hours of reflection, the investigator will confirm the patient's understanding of the study, and those expressing verbal willingness will be randomized into the two groups. Visit 1: Participants will be weighed and required to fill out eight questionnaires on a secure platform. Mindful eating program: group sessions one evening a week (8x2h) and home exercises (30 min/day). Visit 2: visit identical to visit 1 Follow-up group session: To assess each person's progress according to their needs, resources, difficulties, life plans, and initial expectations. Visit 3: visit identical to visit 1 Focus groups: Each participant will be asked to describe the program and talk about their perceptions and feelings, as well as the potential changes in behavior they have observed in their daily life.

Active Comparator: Conventional Dietetic Intervention (DC group)

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.

Behavioral: Conventional Dietetic Intervention (DC group)

Outcome Measures

Primary Outcome Measures

Variation in the level of mindful eating. [Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).]
It will be measured by the Mind-Eat Scale questionnaire. The Mind-Eat Scale is the first questionnaire to provide a total score of the level of mindful eating and is available in French. This questionnaire was developed and validated as part of the Mind-eat project led by our research team, and the corresponding scientific publication is currently being published.

Secondary Outcome Measures

Variation in anxiety and depression levels. [Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).]
It will be measured by the Hospital Anxiety and Depression scale (HAD) questionnaire. The HAD scale is a screening instrument for anxiety and depressive disorders. It comprises 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven to depression (total D), giving two scores (maximum score for each = 21). A score of 0 to 7 means: no symptoms A score between 8 and 10 means: doubtful symptomatology A score of 11 to 21 means: definite symptomatology The higher the score, the more stress and depression are present.
Variation in the level of intuitive eating. [Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).]
It will be measured by the IES-2-French version questionnaire.
Variation in the level of compulsive eating. [Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).]
It will be measured by the BES-French version questionnaire.
Variation in the level of mindfulness. [Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).]
It will be measured by the FFMQ-French version questionnaire.
Variation in eating behavior. [Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).]
It will be measured by the DEBQ-French version questionnaire.
Variation in physical activity levels. [Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).]
It will be measured by the Ricci-Gagnon metric questionnaire.
Variation in stress levels. [Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).]
It will be measured by the PSS-French version questionnaire.
Gross weight loss (kg) [Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).]
It will be measured by a doctor from the Nutrition-Diabetes Department of the Montpellier University Hospital.

Other Outcome Measures

Impact of the program on participants' lives [3 months and 3 weeks after the end of the program]
The focus groups will highlight changes in behavior, points of view, positive or negative experiences, and/or suggestions for improving the program.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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 < 40kg/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