Clusters in Obesity: Intuitive Eating and Mental Health Key for Personalisation

NCT06125600 | Completed

• 1 other identifier: IRB-MTP_2023_02_202301328
• Study Type: observational
• Target: 989
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To determine clusters among weight-loss-seeking individuals for personalised obesity management and find questionnaires to help identify those who could benefit from psychological support. Design: In a cross-sectional analysis using an online platform (Aviitam®), a cluster analysis was carried out in overweight/obese adults. The following questionnaires were studied: Hospital Anxiety and Depression Scale (HADS), Perceived Stress Scale (PSS), Epworth Sleepiness Scale, Morin's Insomnia Scale, Intuitive Eating Scale-2 (IES-2), Binge Eating Scale (BES), a Physical Activity questionnaire and EQ-5D Quality-of-Life questionnaire. Setting: An online weight management platform (Aviitam®) used by adults with obesity across France. Participants: Adults with body mass index (BMI) \>25 kg/m² participating in a weight management pathway who completed validated questionnaires assessing psychological and lifestyle factors. Main Outcomes: Identification of clusters based on questionnaire responses, BMI, age and gender.

Conditions

Obesity; Anxiety; Stress

Outcome Measures

Primary Outcomes (7)

• Hospital Anxiety and Depression Scale (HADS)

  Self-assessment questionnaire for anxiety and depression. The higher the score, the greater the anxiety and depression. Continuous variable. No threshold value for this study.

  90 days after registry in the platform

• The Perceived Stress Scale (PSS)

  Self-assessment questionnaire for stress. The higher the score, the greater the stress. Continuous variable. No threshold value for this study.

  90 days after registry in the platform

• The Epworth Sleepiness Scale

  Self-questionnaire to measure drowsiness. The higher the score, the greater the drowsiness. Continuous variable. No threshold value for this study.

  90 days after registry in the platform

• "Morin's Insomnia" Scale

  Self-questionnaire to measure insomnia. The higher the score, the greater the insomnia. Continuous variable. No threshold value for this study.

  90 days after registry in the platform

• The Intuitive Eating Scale-2 (IES-2)

  self-administered questionnaire measuring intuitive nutrition. The higher the score, the greater the degree of intuitive nutrition. Continuous variable. No threshold value for this study.

  90 days after registry in the platform

• The Binge Eating Scale (BES)

  self-administered questionnaire measuring compulsive eating. the higher the score, the greater the degree of compulsive eating. Continuous variable. No threshold value for this study.

  90 days after registry in the platform

• "Ricci and Gagnon" Physical Activity questionnaire

  self-administered questionnaire to measure physical fitness. The higher the score, the greater the fitness. Continuous variable. No threshold value for this study.

  90 days after registry in the platform

Secondary Outcomes (1)

• self-reported BMI

  90 days after registry in the platform

Interventions

Clustering of people living with obesity using behavioural questionnaires OTHER

In a cross-sectional analysis using the online Aviitam® platform, a cluster analysis was carried out in overweight/obese adults. The following questionnaires were studied: Hospital Anxiety and Depression Scale (HADS), Perceived Stress Scale (PSS), Epworth Sleepiness Scale, Morin's Insomnia Scale, Intuitive Eating Scale-2 (IES-2), Binge Eating Scale (BES), Ricci/Gagnon Physical Activity questionnaire and EQ-5D Quality-of-Life questionnaire.

Eligibility Criteria

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

Study Population

All persons who provided informed consent by accepting the Aviitam platform's General Terms and Conditions of Use (GTCU). The study uses an online platform (my.aviitam.com) which enables patients to provide personal information, respond to health questionnaires (validated or specific to the platform) and receive educational content about their pathology. An automatic summary is generated by the platform to facilitate patient care by the practitioner. The platform is accessible throughout France and is free of charge for both healthcare providers and patients. Furthermore, the online platform is a patient follow-up tool, with patients and healthcare professionals having access to the platform for patient management.

You may qualify if:

• Body Mass Index (BMI) ≥ 25 kg/m² who agreed to the terms of use for their data to be included in the study.
• Answered to, at least, IES2 and HAD questionaries threw online digital platform (Aviitam®)

You may not qualify if:

• non-completion of mandatory questionnaires and a delay of more than 90 days between weight measurement and questionnaire completion.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU Montpellier

Montpellier, 34000, France

Location

MeSH Terms

Conditions

Obesity; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Jean-baptiste BONNET

Study Record Dates

• First Submitted: October 29, 2023
• First Posted: November 9, 2023
• Study Start: August 1, 2023
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

FR (1)