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临床试验/NCT06125600
NCT06125600已完成不适用

Obesity Clusters Using an Online Responsive-Design Platform: Intuitive Eating and Mental Health Key for Personalised Medicine

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 989 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
989
试验地点
1
主要终点
The Perceived Stress Scale (PSS)

研究概览

简要总结

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.

详细描述

Obesity, a rapidly escalating public health issue worldwide, affects over 650 million adults. It leads to serious health consequences such as cardiovascular disease, hepatic steatosis, cancer and Obstructive Sleep Apnea syndrome (OSA). Obesity also has several social repercussions impacting quality of life. These multifaceted health issues emerge from an intricate interplay of biological, environmental and psychological factors.

Managing obese individuals in a primary care setting is difficult and time-consuming. It requires addressing related conditions such as perceived stress, sleep disorders as well as mental health issues including anxiety and depression. All of these conditions can influence a patient's ability to lose weight and maintain weight loss over time. Moreover, factors such as eating habits, compulsive eating and physical activity levels also play critical roles.

In response to these challenges, the investigators have developed an online platform (Avittam®), a digitally-enabled, person-centred online platform designed not only for obesity but also for various chronic conditions including Type 2 diabetes, sleep disorders, childhood obesity, bariatric surgery pathways and even rare diseases like tuberous sclerosis. The online platform (Aviitam®) streamlines healthcare consultations by providing a library of self-administered questionnaires covering an array of factors such as nutrition, physical activity, sleep, mental health, quality of life and medication adherence (Supplementary data eTable 1). Operational since 2014, the platform serves nearly 3000 healthcare professionals and around 18,000 patients across France.

This study focused exclusively on those who had engaged with the online platform's obesity management pathways. It aimed to identify distinct psychological and behavioural clusters among individuals seeking weight loss, thereby informing a more personalised, psychologically supportive treatment strategy.

METHODS Study design This study is an exploratory, observational and cross-sectional analysis of data collected from patients using the online platform. The primary aim was to identify patient clusters based on various self-reported and clinically validated variables. The study was approved by the Institutional Review Board (IRB) of the University Hospital of Montpellier, France (identification number: IRB-MTP_2023_02_202301328). All participants in this study provided informed consent by accepting the online platform's General Terms and Conditions of Use (GTCU), which explicitly state that their data may be used for research purposes. The online platform has received approval from the French data protection authority, the "Commission Nationale de l'Informatique et des Libertés" (CNIL), ensuring GDPR compliance and the confidentiality and protection of participants' rights. To maintain privacy, all data used in this study were anonymised. Patients or the public were not involved in the design, or conduct, or reporting, or dissemination plans of the research.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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®)

排除标准

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

结局指标

主要结局

The Perceived Stress Scale (PSS)

时间窗: 90 days after registry in the platform

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

The Epworth Sleepiness Scale

时间窗: 90 days after registry in the platform

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

The Intuitive Eating Scale-2 (IES-2)

时间窗: 90 days after registry in the platform

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.

The Binge Eating Scale (BES)

时间窗: 90 days after registry in the platform

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.

"Morin's Insomnia" Scale

时间窗: 90 days after registry in the platform

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

Hospital Anxiety and Depression Scale (HADS)

时间窗: 90 days after registry in the platform

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.

"Ricci and Gagnon" Physical Activity questionnaire

时间窗: 90 days after registry in the platform

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

次要结局

  • self-reported BMI(90 days after registry in the platform)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jean-Baptiste BONNET

Dr. Jean-baptiste BONNET

University Hospital, Montpellier

研究点 (1)

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