Interventions to Remedy the Negative Effects of Obesity Stigma

December 22, 2025 updated by: Poitiers University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
210

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
    • Vienne
      • Poitiers, Vienne, France, 86000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: STEREOBES Workshops
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".
Behavioral: Un Poids en moins
Standard intervention proposed by "La Vie la Santé"

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Poitiers University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STEREOBES

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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