Adapting Mindful Eating Program for French Overweight/Obese Population

NCT06157411 | Completed DMC

• 1 other identifier: RECHMPL22_0210
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

Mindful eating; Mindfulness; Validation program; Mixed methods

Outcome Measures

Primary Outcomes (1)

• Variation in the level of mindful eating.

  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 Outcomes (8)

• 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).

• 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).

• 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).

• 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).

• 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).

Other Outcomes (1)

• Impact of the program on participants' lives

  3 months and 3 weeks after the end of the program

Study Arms (2)

Mindful Eating Intervention (AC group)

EXPERIMENTAL

* 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)

Conventional Dietetic Intervention (DC group)

ACTIVE COMPARATOR

* 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)

Interventions

Mindful Eating Intervention (AC group) BEHAVIORAL

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.

Mindful Eating Intervention (AC group)

Conventional Dietetic Intervention (DC group) BEHAVIORAL

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

Conventional Dietetic Intervention (DC group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Antoine Avignon

Montpellier, 34000, France

Location

Related Publications (3)

• Van Beekum M, Shankland R, Rodhain A, Robert M, Marchand C, Herry A, Prioux C, Touvier M, Barday M, Turgon R, Avignon A, Leys C, Peneau S. Development and validation of the mindful eating scale (mind-eat scale) in a general population. Appetite. 2024 Aug 1;199:107398. doi: 10.1016/j.appet.2024.107398. Epub 2024 May 6.

  PMID: 38710449 RESULT

• Paolassini-Guesnier P, Van Beekum M, Kesse-Guyot E, Baudry J, Shankland R, Rodhain A, Bellicha A, Leys C, Hercberg S, Touvier M, Alles B, Peneau S. Mindful eating is associated with a healthier plant-based diet in the NutriNet-Sante study. Sci Rep. 2025 Jun 6;15(1):19928. doi: 10.1038/s41598-025-02195-5.

  PMID: 40481021 RESULT

• Paolassini-Guesnier P, Van Beekum M, Kesse-Guyot E, Baudry J, Srour B, Bellicha A, Shankland R, Rodhain A, Leys C, Hercberg S, Touvier M, Alles B, Peneau S. Mindful eating is associated with a better diet quality in the NutriNet-Sante study. Appetite. 2025 Feb 1;206:107797. doi: 10.1016/j.appet.2024.107797. Epub 2024 Dec 3.

  PMID: 39638150 RESULT

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Antoine Avignon, PU-PH

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: December 5, 2023
• Study Start: February 16, 2024
• Primary Completion: January 10, 2025
• Study Completion: January 10, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)