Clinical trial NCT05906238: Interventions to Remedy the Negative Effects of Obesity Stigma
Official title: Development, Implementation and Evaluation of Interventions to Remediate the Threatening Effects of Obesity Stereotyes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Stigma, Weight
Keywords: Obesity
Therapeutic patient education
Stigmatization
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Obesity-specific personal efficacy
timeFrame: At Baseline, 3 months follow up, 6 months follow up, 12 months follow up, 6 months after the end of the program
Secondary outcomes:
measure: Brief Coping Responses Inventory (BCRI-10)
timeFrame: At Baseline, 3 months follow up, 6 months follow up, 12 months follow up, 6 months after the end of the program
measure: Weight Bias Internalization Scale
timeFrame: At Baseline, 3 months follow up, 6 months follow up, 12 months follow up, 6 months after the end of the program
measure: Body Shape Questionnaire (BSQ-14)
timeFrame: At Baseline, 3 months follow up, 6 months follow up, 12 months follow up, 6 months after the end of the program
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Poitiers University Hospital
state: Vienne
Study officials:
References: