Adapting Mindful Eating Program for French Overweight/Obese Population
NCT ID: NCT06157411
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
56 participants
INTERVENTIONAL
2024-02-16
2025-01-10
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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
Interventions
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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.
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
Eligibility Criteria
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Inclusion Criteria
* Adults aged 18 and over, volunteers
* BMI ≥ 25kg/m² and ≤ 50kg/m²
* Provisional verbal consent followed by signed written consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Antoine Avignon, PU-PH
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Montpellier
Locations
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Antoine Avignon
Montpellier, , France
Countries
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References
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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.
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.
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.
Other Identifiers
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RECHMPL22_0210
Identifier Type: -
Identifier Source: org_study_id