ObesityNCT05906238
Interventions to Remedy the Negative Effects of Obesity Stigma
A study testing STEREOBES Workshops and Un Poids en moins in people with Obesity and Stigma, Weight, run by Poitiers University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Stigma, Weight
- What is being tested?
- STEREOBES Workshops and Un Poids en moins
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2023to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI > 30
- Patient affiliated to or benefiting from a social security scheme.
Who cannot join
- Patient suffering from an uncontrolled psychiatric illness with no suitable treatment in place (e.g. schizophrenia, bipolar disorder, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Poitiers University Hospital
Poitiers, Vienne, 86000
Marion Albouy, Physician, 0549443323, Marion.ALBOUY@chu-poitiers.fr
About this study
Official title: Development, Implementation and Evaluation of Interventions to Remediate the Threatening Effects of Obesity Stereotyes
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.
Read the 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.
- Conditions
- Obesity, Stigma, Weight
- Being tested
- STEREOBES Workshops, Un Poids en moins
- Keywords
- Obesity, Therapeutic patient education, Stigmatization
- Medical subject headings
- Obesity, Weight Prejudice, Stereotyping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STEREOBES WorkshopsBehavioural
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.
Un Poids en moinsBehavioural
Standard intervention proposed by "La Vie la Santé"
| Study group | Role | What they receive |
|---|---|---|
| STEREOBES | Experimental | 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. Receives: Behavioral: STEREOBES Workshops |
| CONTROL | Active comparator | This arm will follow the standard therapeutic patient education program proposed by "La Vie La Santé". Receives: Behavioral: Un Poids en moins |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: At Baseline, 3 months follow up, 6 months follow up, 12 months follow up, 6 months after the end of the program
Secondary outcomes (3)
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).
Measured: 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
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".
Measured: 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)
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).
Measured: At Baseline, 3 months follow up, 6 months follow up, 12 months follow up, 6 months after the end of the program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start10 Oct 2023
- Primary completionApr 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05906238
- Sponsor's protocol ID
- STEREOBES
- Status last verified
- Dec 2025
- First submitted
- 7 Jun 2023
- Last updated
- 29 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ramsamy G, Esnard C; STEREOBES Consortium; Mosbah H, Soussi Berjonval D, Faure JP, Albouy M. Effect of a patient education program focused on weight stigma on quality of life and self-efficacy in patients living with obesity: study protocol for a randomized controlled trial. BMC Psychol. 2024 Dec 18;12(1):734. doi: 10.1186/s40359-024-02274-8.
PubMed 39696393
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Implementation and Evaluation of Interventions to Remediate the Threatening Effects of Obesity Stereotyes
- ClinicalTrials.gov ID
- NCT05906238
- Acronym / sponsor ID
- STEREOBES
- Conditions
- Obesity, Stigma, Weight
- Keywords
- Obesity, Therapeutic patient education, Stigmatization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEREOBES | Experimental | Behavioral: STEREOBES WorkshopsThis 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. |
| CONTROL | Active comparator | Behavioral: Un Poids en moinsThis arm will follow the standard therapeutic patient education program proposed by "La Vie La Santé". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI > 30
- Patient affiliated to or benefiting from a social security scheme.
Key exclusion criteria (1 listed)
- Patient suffering from an uncontrolled psychiatric illness with no suitable treatment in place (e.g. schizophrenia, bipolar disorder, etc.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STEREOBES WorkshopsThese 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. | Behavioural | STEREOBES |
| Un Poids en moinsStandard intervention proposed by "La Vie la Santé" | Behavioural | CONTROL |
Primary outcome
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".
3 secondary outcomes
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Derived from this study: PubMed 39696393Ramsamy G, Esnard C; STEREOBES Consortium; Mosbah H, Soussi Berjonval D, Faure JP, Albouy M. Effect of a patient education program focused on weight stigma on quality of life and self-efficacy in patients living with obesity: study protocol for a randomized controlled trial. BMC Psychol. 2024 Dec 18;12(1):734. doi: 10.1186/s40359-024-02274-8.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STEREOBES Workshops and Un Poids en moins in people with Obesity and Stigma, Weight, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marion Albouy, Physician (0549443323, marion.albouy@univ-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05906238, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.