Interventions to Remedy the Negative Effects of Obesity Stigma
Primary Purpose
Obesity, Stigma, Weight
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
STEREOBES Workshops
Un Poids en moins
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring Obesity, Patient education, stigmatisation
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.).
Sites / Locations
- Poitiers University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
STEREOBES
CONTROL
Arm Description
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.
This arm will follow the standard therapeutic patient education program proposed by "La Vie La Santé".
Outcomes
Primary Outcome Measures
Obesity-specific personal efficacy
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".
Secondary Outcome Measures
Brief Coping Responses Inventory (BCRI-10)
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).
Weight Bias Internalization Scale
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".
Body Shape Questionnaire (BSQ-14)
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).
Full Information
NCT ID
NCT05906238
First Posted
June 7, 2023
Last Updated
June 7, 2023
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05906238
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2023 (Actual)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Stigma, Weight
Keywords
Obesity, Patient education, stigmatisation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
STEREOBES
Arm Type
Experimental
Arm Description
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.
Arm Title
CONTROL
Arm Type
Active Comparator
Arm Description
This arm will follow the standard therapeutic patient education program proposed by "La Vie La Santé".
Intervention Type
Behavioral
Intervention Name(s)
STEREOBES Workshops
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Un Poids en moins
Intervention Description
Standard intervention proposed by "La Vie la Santé"
Primary Outcome Measure Information:
Title
Obesity-specific personal efficacy
Description
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".
Time Frame
At Baseline, 3 months follow up, 6 months follow up, 12 months follow up, 6 months after the end of the program
Secondary Outcome Measure Information:
Title
Brief Coping Responses Inventory (BCRI-10)
Description
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).
Time Frame
At Baseline, 3 months follow up, 6 months follow up, 12 months follow up, 6 months after the end of the program
Title
Weight Bias Internalization Scale
Description
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".
Time Frame
At Baseline, 3 months follow up, 6 months follow up, 12 months follow up, 6 months after the end of the program
Title
Body Shape Questionnaire (BSQ-14)
Description
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).
Time Frame
At Baseline, 3 months follow up, 6 months follow up, 12 months follow up, 6 months after the end of the program
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marion Albouy, Physician
Phone
0549443323
Email
marion.albouy@univ-poitiers.fr
Facility Information:
Facility Name
Poitiers University Hospital
City
Poitiers
State/Province
Vienne
ZIP/Postal Code
86000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion Albouy, Physician
Phone
0549443323
Email
Marion.ALBOUY@chu-poitiers.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Interventions to Remedy the Negative Effects of Obesity Stigma
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