跳至主要内容
临床试验/NCT05906238
NCT05906238招募中不适用

Development, Implementation and Evaluation of Interventions to Remediate the Threatening Effects of Obesity Stereotyes

Poitiers University Hospital2 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2023年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
210
试验地点
2
主要终点
Obesity-specific personal efficacy

研究概览

简要总结

This project proposes to integrate a psychosocial approach into the therapeutic patient education program (TPE) at "La Vie la Santé", an innovative health promotion platform at Poitiers University Hospital. A randomized study will be set up within the active file of patients referred by the specialized obesity center of Poitou-Charentes and integrated into this patient education program (TPE) program. Patients randomized to the TPE-STEREOBES experimental cohort arm will participate for 12 months in obesity-specific adapted physical activity workshops, on the one hand, and in workshops based on "social well-being" on the other, designed as part of this study. They will be assessed when they enter the program (T0), then at 3 months (T3), 6 months (T6), 12 months (T12) and finally 6 months later (T18). Assessments at T0, T12 and T18 will be compared with those of patients in the control group, made up of patients followed up at the specialized obesity center who were not included in the TPE-STEREOBES program.

详细描述

Obesity is a major public health issue, affecting 17% of the population. It is also a major societal issue, due to the "grossophobia" and discriminatory attitudes to which obese people are subjected. Widely documented in the literature, the "stereotype threat" effect of obesity has negative psychological consequences (e.g. stress, anxiety, reduced self-esteem, deterioration of self-image, impaired cognitive functions), can lead to the adoption of pathogenic behaviors (e.g. energy-dense foods, limitation of physical activity, avoidance of social situations) and therefore generates a deterioration in quality of life. To date, while the psychotherapeutic support of obese patients and the provision of adapted physical activities have been well documented, no intervention targeting the deleterious effects of this obesity stereotype threat has been tested in the medical follow-up of obese patients.

This innovative project aims to develop, implement and evaluate psychosocial interventions to remediate the effects of obesity stereotypes on severely obese patients. Its aim is to improve their sense of self-efficacy, a factor recognized as an antecedent of behavioral and attitudinal changes that contribute to improving their quality of social life and health status. To this end, this project proposes to integrate a psychosocial approach into the therapeutic patient education (TPE) program at "Vie la Santé", an innovative health promotion platform at Poitiers University Hospital. A randomized study will be set up within the active file of patients referred by the Poitou-Charentes specialized obesity center and integrated into this therapeutic patient education (TPE) program. Patients randomized to the ETP-STEREOBES experimental cohort arm will participate for 12 months in obesity-specific APA workshops, on the one hand, and in workshops based on "social well-being" on the other, designed as part of this study. They will be assessed when they enter the program (T0), then at 3 months (T3), 6 months (T6), 12 months (T12) and finally 6 months later (T18). Assessments at T0, T12 and T18 will be compared with those of patients in the control group, made up of patients attending a specialized obesity center who are not included in the ETP-STEREOBES program.

The benefits of this study will be not only individual, but also collective and institutional, by providing the partners and beneficiaries of this research with operational and innovative knowledge, tools and practices contributing to the fight against discrimination, notably via a showcase website and the scientific dissemination of research findings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

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

  • BMI > 30
  • Patient affiliated to or benefiting from a social security scheme.

排除标准

  • Patient suffering from an uncontrolled psychiatric illness with no suitable treatment in place (e.g. schizophrenia, bipolar disorder, etc.).

结局指标

主要结局

Obesity-specific personal efficacy

时间窗: At Baseline, 3 months follow up, 6 months follow up, 12 months follow up, 6 months after the end of the program

Obesity-specific personal efficacy is recognized in the literature as one of the determinants of attitudinal and behavioral change. This is a 40-item scale grouping together 4 dimensions: Eating Behavior Management (EBM), Physical Activity (PA), Self-Image and How Others See You (SIRA), Social Relations (SR). For each item, the patient indicates a score from 1 "not at all capable" to 10 "completely capable".

次要结局

  • Weight Bias Internalization Scale(At Baseline, 3 months follow up, 6 months follow up, 12 months follow up, 6 months after the end of the program)
  • Body Shape Questionnaire (BSQ-14)(At Baseline, 3 months follow up, 6 months follow up, 12 months follow up, 6 months after the end of the program)
  • Brief Coping Responses Inventory (BCRI-10)(At Baseline, 3 months follow up, 6 months follow up, 12 months follow up, 6 months after the end of the program)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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