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

December 15, 2025 updated by: University Hospital, Montpellier

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34000
        • Antoine Avignon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation in the level of mindful eating.
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation in anxiety and depression levels.
Time Frame: 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.
Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
Variation in the level of intuitive eating.
Time Frame: 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.
Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
Variation in the level of compulsive eating.
Time Frame: 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.
Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
Variation in the level of mindfulness.
Time Frame: 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.
Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
Variation in eating behavior.
Time Frame: 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.
Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
Variation in physical activity levels.
Time Frame: 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.
Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
Variation in stress levels.
Time Frame: 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.
Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
Gross weight loss (kg)
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of the program on participants' lives
Time Frame: 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.
3 months and 3 weeks after the end of the program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Antoine Avignon, PU-PH, University Hospital, Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2024

Primary Completion (Actual)

January 10, 2025

Study Completion (Actual)

January 10, 2025

Study Registration Dates

First Submitted

November 17, 2023

First Submitted That Met QC Criteria

November 27, 2023

First Posted (Actual)

December 5, 2023

Study Record Updates

Last Update Posted (Actual)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL22_0210

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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