Adapting Mindful Eating Program for French Overweight/Obese Population

Overweight and Obesity Clinical Trial

— MIND-EAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06157411
• Other study ID #: RECHMPL22_0210
• Status: Recruiting
• Phase: N/A
• Start date: February 16, 2024
• Est. completion date: October 17, 2024

Study information

• Verified date: February 2024
• Source: University Hospital, Montpellier
• Contact: Antoine Avignon, PU-PH
• Phone: 04 67 33 84 02
• Email: a-avignon[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: October 17, 2024
• Est. primary completion date: October 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Intervention

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.
• 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

Locations

Country	Name	City	State
France	Antoine Avignon	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Impact of the program on participants' lives	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
Primary	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	Variation in anxiety and depression levels.	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).
Secondary	Variation in the level of intuitive eating.	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).
Secondary	Variation in the level of compulsive eating.	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).
Secondary	Variation in the level of mindfulness.	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).
Secondary	Variation in eating behavior.	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).
Secondary	Variation in physical activity levels.	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).
Secondary	Variation in stress levels.	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).
Secondary	Gross weight loss (kg)	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).