- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05906238
Interventions to Remedy the Negative Effects of Obesity Stigma
Development, Implementation and Evaluation of Interventions to Remediate the Threatening Effects of Obesity Stereotyes
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marion Albouy, Physician
- Phone Number: 0549443323
- Email: marion.albouy@univ-poitiers.fr
Study Locations
-
-
Vienne
-
Poitiers, Vienne, France, 86000
- Recruiting
- Poitiers University Hospital
-
Contact:
- Marion Albouy, Physician
- Phone Number: 0549443323
- Email: Marion.ALBOUY@chu-poitiers.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: STEREOBES
This arm will follow a program developed specifically for this project.
It will include specific workshops on obesity stigma issues which are not part of the standard program.
|
These workshops are designed to help patients develop appropriate behaviors to deal with stigmatizing situations.
They will focus on three main areas: adapted physical activities, nutrition and mental well-being.
They will include sessions on developing self-esteem, improving body image and managing emotions.
The aim will be to deconstruct the myths and stereotypes surrounding obesity.
|
|
Active Comparator: CONTROL
This arm will follow the standard therapeutic patient education program proposed by "La Vie La Santé".
|
Standard intervention proposed by "La Vie la Santé"
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Obesity-specific personal efficacy
Time Frame: 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".
|
At Baseline, 3 months follow up, 6 months follow up, 12 months follow up, 6 months after the end of the program
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brief Coping Responses Inventory (BCRI-10)
Time Frame: At Baseline, 3 months follow up, 6 months follow up, 12 months follow up, 6 months after the end of the program
|
This scale comprises 10 items grouping together 2 dimensions: reappraisal coping and disengagement coping.
Items are measured on a scale from 0 (Never) to 4 (Always).
|
At Baseline, 3 months follow up, 6 months follow up, 12 months follow up, 6 months after the end of the program
|
|
Weight Bias Internalization Scale
Time Frame: At Baseline, 3 months follow up, 6 months follow up, 12 months follow up, 6 months after the end of the program
|
Patients indicate on 10 items their degree of agreement with the proposed statements on a 7-point Likert scale ranging from 1 "completely disagree" to 7 "completely agree".
|
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)
Time Frame: At Baseline, 3 months follow up, 6 months follow up, 12 months follow up, 6 months after the end of the program
|
This scale measures preoccupation and dissatisfaction with one's body because of weight.
It consists of 14 items ranging from 1 (never) to 6 (always).
|
At Baseline, 3 months follow up, 6 months follow up, 12 months follow up, 6 months after the end of the program
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STEREOBES
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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