Weight BiasNCT07334470
Weight Bias Reducation Intervention With Nursing Students Using Simulation: The BRAVE Study
A study testing BRAVE and SOL: Standard Obesity Lecture in people with Weight Bias, run by Villanova University at 1 site in United States.
Trial summary
This randomized controlled trial will be a curriculum-embedded weight sensitivity training program. There will be two groups. The control group will receive the standard obesity lecture (SOL) and the intervention group will receive the BRAVE Intervention (BRAVE: Building Respect and Acceptance through Valuing… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Weight Bias
- What is being tested?
- BRAVE and SOL: Standard Obesity Lecture
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 368 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2026to 20 May 2028
- 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 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Nursing students aged 18-35
- Nursing students during their second or fourth year of the traditional or FLEX BSN undergraduate curriculum (in specified nursing courses)
Who cannot join
- Non-nursing students
- Nursing students taking courses out of the normal curriculum sequence
- Nursing students who are not of traditional undergraduate ages (18-35 years)
- Students who decline to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Villanova University
Villanova, Pennsylvania, 19085-1603
Tracy Oliver, PhD, RDN, LDN, 610-519-4917, tracy.oliver@villanova.edu
Bette Mariani, PhD, RN, ANEF, FAAN, 610-519-4933, Bette.Mariani@villanova.edu
About this study
Official title: The BRAVE Study: A Sensitivity Intervention With Nursing Students Using Simulation
This randomized controlled trial will be a curriculum-embedded weight sensitivity training program. There will be two groups. The control group will receive the standard obesity lecture (SOL) and the intervention group will receive the BRAVE Intervention (BRAVE: Building Respect and Acceptance through Valuing Everybody); a Weight Bias Reduction (WBR) intervention. Both groups will have two simulation encounters with standardized patients who are living with obesity and the outcome will be to improve weight bias and increase weight sensitivity over one year. Participants will include second- and fourth-year nursing students. Two cohorts of nursing students will be recruited over two years during orientation for their NUR courses (n = 368); a combined total of 420 students are typically enrolled in these courses. Study participants will be randomized by 8-person simulation groups (clusters) to either the BRAVE intervention or SOL control group. They will then participate in the two simulation-based experiences and weight bias reduction education or standard obesity lecture, respectively, with a debriefing segment and educational components. To compare the efficacy of BRAVE groups to SOL groups in validated questionnaires will assess changing attitudes, beliefs, and clinical communication behaviors when comparing baseline to 3 months post-intervention, and one year after the intervention.
Read the detailed description
Longstanding evidence documents the detrimental effects of provider biases on poor patient outcomes. Weight bias among nurses is an understudied concept that causes increased morbidity and mortality in populations living with obesity. Specifically, studies show that nurses with weight bias: 1) assume patients' symptoms are related to obesity and do not further probe underlying causes, 2) are more reluctant to perform preventative health screenings (such as pelvic examinations, cancer screenings, and mammograms), 3) spend less time engaging with patients during visits, all of which causes patients to withdraw from the provider, potentially resulting in difficulty remembering or adhering to provider advice and avoiding future preventative care visits.
Given the increasing rates of obesity in the United States, efforts are direly needed to improve the care provided by nurses who work with this demographic to thwart preventable health consequences (e.g., diabetes, heart disease). Our previous research showed favorable improvements in nursing students' attitudes and beliefs toward individuals with obesity following a Weight Bias Reduction (WBR) intervention when implemented into their clinical course. Gaps remain, however, in 1) whether WBR interventions can translate into behavior change in clinical practice and make notable reductions in the weight bias patients are experiencing, and 2) whether these changes are sustained over time. To fill these gaps, the proposed BRAVE (Building Respect and Acceptance through Valuing Everybody, WBR intervention) will build on our previous research to include education on communication skills and empathic competence, as well as utilize simulation with standardized participants living with obesity.
The study design is a cluster-randomized controlled trial comparing BRAVE to SOL (Standard Obesity Lecture) in reducing weight bias among nursing students (n = 368) and will include follow-up measures to determine the intervention's sustained effects one year later. Additionally, the broader impacts of this BRAVE intervention can enhance long-term health outcomes with the potential for improved patient satisfaction while navigating the healthcare system.
AIM 1: To compare the efficacy of BRAVE groups to SOL groups in changing attitudes, beliefs, and clinical communication behaviors when comparing baseline to 3 months post-intervention.
Hypothesis 1: BRAVE groups will demonstrate statistically significant improvements in attitudes, beliefs, and clinical communication behaviors that are greater than those of SOL groups when comparing baseline and 3 months post-intervention.
- Attitudes will be measured by Attitudes Towards Higher Weight Persons (ATOP-HW) Questionnaire scores.
- Beliefs will be measured by Beliefs About Obese Persons (BAOP) Questionnaire scores.
- Clinical Communication Behaviors will be measured by SE-12, WSI, and SEGUE scores.
AIM 2: To evaluate whether changes in attitudes, beliefs, and clinical communication behaviors between BRAVE and SOL groups are sustained over a one-year period.
Hypothesis 2: BRAVE groups will sustain statistically significant improvements in attitudes, beliefs, and clinical communication behaviors toward obesity compared to SOL groups when assessed from Session 2 to Session 3 one year post-intervention.
Attitudes will be measured by Attitudes Towards Higher Weight Persons (ATOP-HW) Questionnaire scores.
Beliefs will be measured by the Beliefs About Obese Persons (BAOP) Questionnaire scores.
Clinical Communication Behaviors (self-efficacy) will be measured by the SE-12 scores.
- Conditions
- Weight Bias
- Being tested
- BRAVE, SOL: Standard Obesity Lecture
- Keywords
- weight bias, nursing education, obesity
- Medical subject headings
- Weight Prejudice, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRAVEBehavioural
In addition to the two simulation encounters, the BRAVE arm will include an initial one-hour educational presentation on weight bias in health care; prevalence, and influences of weight bias on health/health care, factors affecting obesity, approaching weight-related discussions with patients with sensitivity and empathy, and effective communication strategies. Clinical communication behaviors will also be taught, such as asking permission, using non-stigmatizing language, and engaging in judgment-free weight-related discussions with patients. They will also have role-play and case-study scenarios to integrate and practice the communication strategies. Following the second simulation and DML, students in the BRAVE arm will participate in a continuation of the weight bias reduction education including concepts of Motivational Interviewing, Shared Decision Making, and weight management conversations to prevent weight bias in the clinical environment.
SOL: Standard Obesity LectureBehavioural
SOL: (Standard Obesity Lecture) SOL arm education will include a presentation on obesity as a disease, its prevalence, causes, health risks, psychological and socioeconomic impact, and a standard obesity assessment. Following the second simulation, students in the SOL groups will participate in a continuation of the standard obesity education to build on concepts from session 1. The second presentation will be a recap on weight management in clinical practice. Readings will focus on the medical consequences of obesity, and the economic cost of obesity. Both Debriefing for Meaningful Learning segments will focus on the disease itself and not include components of obesity or body weight.
| Study group | Role | What they receive |
|---|---|---|
| BRAVE Intervention | Experimental | BRAVE (Building Respect and Acceptance through Valuing Everybody). Participants will receive two 30-minute Simulated Patients (SP) encounters: 1 at baseline (before the weight bias or obesity presentations) and one at 1.5 months after the initial education. The simulation encounters will include SPs living with higher body weight and will emphasize communication skills to prevent weight bias in the clinical environment. BRAVE arm will consist of two educational sessions focused on reducing weight bias in health care. Both BRAVE SP encounters will provide a Debriefing for Meaningful Learning segment tailored to focus on reducing weight bias. Receives: Behavioral: BRAVE |
| SOL | Placebo comparator | SOL (Standard Obesity Lecture). The control arm will experience two standard obesity lectures and two simulation encounters with standardized patients living with higher body weight. The control condition consists of two sessions, each of which includes a one-hour presentation on obesity. Both simulations will be followed by standard Debriefing for Meaningful Learning segments, but these segments will focus only on the medical conditions and risk factors of obesity and no feedback on communication skills will be provided. Receives: Behavioral: SOL: Standard Obesity Lecture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attitudes Towards Higher Weight Persons (ATOP-HW)
Estimated Mean Change Score.The ATOP-HW is a 20-item Likert rating scale that focuses on perceptions and attitudes about people living with obesity. Higher scores reflect more positive attitudes toward persons with obesity.
Measured: Baseline to 3 Months
Beliefs About Obese Persons Scale (BAOP)
The BAOP is an eight-item Likert rating scale that assesses beliefs about the causes of obesity. Each question asks individuals to indicate the extent of agreement or disagreement (+3 to -3) to a specific statement, such as "obesity is really caused by a lack of willpower." Higher scores indicate beliefs that obesity is not controllable.
Measured: Baseline to 3 Months
SE-12 (Self-Efficacy) Scale
The SE-12 is a 12-item questionnaire assessing self-efficacy by clinicians in clinical communications.
Measured: Baseline to 3 Months
Secondary outcomes (5)
SEGUE Framework
The SEGUE Checklist is a valid and reliable checklist designed to be used in various settings to teach, assess, and improve communication skills with medical providers.The SEGUE acronym stands for Set the Stage, Elicit information, Give information, Understand the patient's perspective, and End the encounter. SEGUE includes a 25-item dichotomous checklist to evaluate whether a task was completed.
Measured: Baseline and 3 Months
Weight Sensitivity Instrument (WSI)
The WSI is a 15-item checklist that will assess aspects of physical assessment skills, patient psychological safety, and weight sensitivity of the session.
Measured: Baseline and 3 Months
Attitudes Towards Higher Weight Persons (ATOP-HW) Questionnaire
The ATOP-HW is a 20-item Likert rating scale that focuses on perceptions and attitudes about obese people. Higher scores reflect more positive attitudes toward persons with obesity.
Measured: Baseline to 1 Year; 3 months to 1 Year
Beliefs About Obese Persons Scale (BAOP)
The BAOP is an eight-item Likert rating scale that assesses beliefs about the causes of obesity. Each question asks individuals to indicate the extent of agreement or disagreement (+3 to -3) to a specific statement, such as "obesity is really caused by a lack of willpower." Higher scores indicate beliefs that obesity is not controllable
Measured: Baseline to 1 Year; 3 months to 1 year
SE-12 (Self-Efficacy) Questionnaire
The SE-12 is a 12-item questionnaire assessing self-efficacy by clinicians in clinical communications.
Measured: Baseline to 1 year; 3 months to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start12 Jan 2026
- Primary completion20 May 2028 (estimated)
- Study completion20 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (62)Papers the sponsor has linked to this study.
- Other trials for Weight BiasStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Villanova University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334470
- Sponsor's protocol ID
- IRB-FY2025-30
- Status last verified
- Jan 2026
- First submitted
- 30 Dec 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Geller G, Watkins PA. Addressing Medical Students' Negative Bias Toward Patients With Obesity Through Ethics Education. AMA J Ethics. 2018 Oct 1;20(10):E948-959. doi: 10.1001/amajethics.2018.948.
PubMed 30346923Gayer GG, Weiss J, Clearfield M. Fundamentals for an Osteopathic Obesity Designed Study: The Effects of Education on Osteopathic Medical Students' Attitudes Regarding Obesity. J Am Osteopath Assoc. 2017 Aug 1;117(8):495-502. doi: 10.7556/jaoa.2017.099.
PubMed 28759091Charlesworth TES, Banaji MR. Patterns of Implicit and Explicit Attitudes: I. Long-Term Change and Stability From 2007 to 2016. Psychol Sci. 2019 Feb;30(2):174-192. doi: 10.1177/0956797618813087. Epub 2019 Jan 3.
PubMed 30605364Bell ML, Rabe BA. The mixed model for repeated measures for cluster randomized trials: a simulation study investigating bias and type I error with missing continuous data. Trials. 2020 Feb 7;21(1):148. doi: 10.1186/s13063-020-4114-9.
PubMed 32033617Makoul G. The SEGUE Framework for teaching and assessing communication skills. Patient Educ Couns. 2001 Oct;45(1):23-34. doi: 10.1016/s0738-3991(01)00136-7.
PubMed 11602365Axboe MK, Christensen KS, Kofoed PE, Ammentorp J. Development and validation of a self-efficacy questionnaire (SE-12) measuring the clinical communication skills of health care professionals. BMC Med Educ. 2016 Oct 18;16(1):272. doi: 10.1186/s12909-016-0798-7.
PubMed 27756291Allison, D.B., Basile, V.C., & Yuker, H.E. (1991). The measurement of attitudes toward and beliefs about obese persons. International Journal of Eating Disorders, 10(5). 599-607
Dreifuerst, K. T. (2015). Getting started with debriefing for meaningful learning. Clinical Simulation in Nursing, 11(5), 268-275. http://dx.doi.org/10.1016/j.ecns.2015.01.005
Douglas, V.J., Kwan, M.Y., Minnich, A.M., Converse, J.N., Wonderlich, J.A., & Gordon, K.H. (2022). An examination of the link between empathy and weight-based victimization. Social Sciences & Humanities Open, 5(1), 100247 https://doi.org/10.1016/j.ssaho.2022.100247
Burke SE, Dovidio JF, Przedworski JM, Hardeman RR, Perry SP, Phelan SM, Nelson DB, Burgess DJ, Yeazel MW, van Ryn M. Do Contact and Empathy Mitigate Bias Against Gay and Lesbian People Among Heterosexual First-Year Medical Students? A Report From the Medical Student CHANGE Study. Acad Med. 2015 May;90(5):645-51. doi: 10.1097/ACM.0000000000000661.
PubMed 25674910Dovidio, J.F., Gaertner, S.L., & Kawakami, K. (2003). Intergroup contact: the past, present, and future. Group Process Intergroup Relations, 6, 5-21.
Pettigrew TF, Tropp LR. A meta-analytic test of intergroup contact theory. J Pers Soc Psychol. 2006 May;90(5):751-83. doi: 10.1037/0022-3514.90.5.751.
PubMed 16737372Allport, G.W. (1954). The Nature of Prejudice, Reading, Massachusetts: Addison-Wesley
Phelan SM, Puhl RM, Burgess DJ, Natt N, Mundi M, Miller NE, Saha S, Fischer K, van Ryn M. The role of weight bias and role-modeling in medical students' patient-centered communication with higher weight standardized patients. Patient Educ Couns. 2021 Aug;104(8):1962-1969. doi: 10.1016/j.pec.2021.01.003. Epub 2021 Jan 5.
PubMed 33487507Kushner RF, Zeiss DM, Feinglass JM, Yelen M. An obesity educational intervention for medical students addressing weight bias and communication skills using standardized patients. BMC Med Educ. 2014 Mar 18;14:53. doi: 10.1186/1472-6920-14-53.
PubMed 24636594
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BRAVE Study: A Sensitivity Intervention With Nursing Students Using Simulation
- ClinicalTrials.gov ID
- NCT07334470
- Acronym / sponsor ID
- IRB-FY2025-30
- Conditions
- Weight Bias
- Keywords
- weight bias, nursing education, obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 368 participants (estimated)
- Lead sponsor
- Villanova UniversityUniversity, hospital or other
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 20 May 2028 (estimated)
- Study completion
- 20 May 2028 (estimated)
- First posted
- 12 Jan 2026 (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 randomized controlled trial will be a curriculum-embedded weight sensitivity training program. There will be two groups. The control group will receive the standard obesity lecture (SOL) and the intervention group will receive the BRAVE Intervention (BRAVE: Building Respect and Acceptance through Valuing Everybody); a Weight Bias Reduction (WBR) intervention. Both groups will have two simulation encounters with standardized patients who are living with obesity and the outcome will be to improve weight bias and increase weight sensitivity over one year. Participants will include second- and fourth-year nursing students. Two cohorts of nursing students will be recruited over two years during orientation for their NUR courses (n = 368); a combined total of 420 students are typically enrolled in these courses. Study participants will be randomized by 8-person simulation groups (clusters) to either the BRAVE intervention or SOL control group. They will then participate in the two simulation-based experiences and weight bias reduction education or standard obesity lecture, respectively, with a debriefing segment and educational components. To compare the efficacy of BRAVE groups to SOL groups in validated questionnaires will assess changing attitudes, beliefs, and clinical communication behaviors when comparing baseline to 3 months post-intervention, and one year after the intervention.
Detailed description
Longstanding evidence documents the detrimental effects of provider biases on poor patient outcomes. Weight bias among nurses is an understudied concept that causes increased morbidity and mortality in populations living with obesity. Specifically, studies show that nurses with weight bias: 1) assume patients' symptoms are related to obesity and do not further probe underlying causes, 2) are more reluctant to perform preventative health screenings (such as pelvic examinations, cancer screenings, and mammograms), 3) spend less time engaging with patients during visits, all of which causes patients to withdraw from the provider, potentially resulting in difficulty remembering or adhering to provider advice and avoiding future preventative care visits.
Given the increasing rates of obesity in the United States, efforts are direly needed to improve the care provided by nurses who work with this demographic to thwart preventable health consequences (e.g., diabetes, heart disease). Our previous research showed favorable improvements in nursing students' attitudes and beliefs toward individuals with obesity following a Weight Bias Reduction (WBR) intervention when implemented into their clinical course. Gaps remain, however, in 1) whether WBR interventions can translate into behavior change in clinical practice and make notable reductions in the weight bias patients are experiencing, and 2) whether these changes are sustained over time. To fill these gaps, the proposed BRAVE (Building Respect and Acceptance through Valuing Everybody, WBR intervention) will build on our previous research to include education on communication skills and empathic competence, as well as utilize simulation with standardized participants living with obesity.
The study design is a cluster-randomized controlled trial comparing BRAVE to SOL (Standard Obesity Lecture) in reducing weight bias among nursing students (n = 368) and will include follow-up measures to determine the intervention's sustained effects one year later. Additionally, the broader impacts of this BRAVE intervention can enhance long-term health outcomes with the potential for improved patient satisfaction while navigating the healthcare system.
AIM 1: To compare the efficacy of BRAVE groups to SOL groups in changing attitudes, beliefs, and clinical communication behaviors when comparing baseline to 3 months post-intervention.
Hypothesis 1: BRAVE groups will demonstrate statistically significant improvements in attitudes, beliefs, and clinical communication behaviors that are greater than those of SOL groups when comparing baseline and 3 months post-intervention.
- Attitudes will be measured by Attitudes Towards Higher Weight Persons (ATOP-HW) Questionnaire scores.
- Beliefs will be measured by Beliefs About Obese Persons (BAOP) Questionnaire scores.
- Clinical Communication Behaviors will be measured by SE-12, WSI, and SEGUE scores.
AIM 2: To evaluate whether changes in attitudes, beliefs, and clinical communication behaviors between BRAVE and SOL groups are sustained over a one-year period.
Hypothesis 2: BRAVE groups will sustain statistically significant improvements in attitudes, beliefs, and clinical communication behaviors toward obesity compared to SOL groups when assessed from Session 2 to Session 3 one year post-intervention.
Attitudes will be measured by Attitudes Towards Higher Weight Persons (ATOP-HW) Questionnaire scores.
Beliefs will be measured by the Beliefs About Obese Persons (BAOP) Questionnaire scores.
Clinical Communication Behaviors (self-efficacy) will be measured by the SE-12 scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BRAVE Intervention | Experimental | Behavioral: BRAVEBRAVE (Building Respect and Acceptance through Valuing Everybody). Participants will receive two 30-minute Simulated Patients (SP) encounters: 1 at baseline (before the weight bias or obesity presentations) and one at 1.5 months after the initial education. The simulation encounters will include SPs living with higher body weight and will emphasize communication skills to prevent weight bias in the clinical environment. BRAVE arm will consist of two educational sessions focused on reducing weight bias in health care. Both BRAVE SP encounters will provide a Debriefing for Meaningful Learning segment tailored to focus on reducing weight bias. |
| SOL | Placebo comparator | Behavioral: SOL: Standard Obesity LectureSOL (Standard Obesity Lecture). The control arm will experience two standard obesity lectures and two simulation encounters with standardized patients living with higher body weight. The control condition consists of two sessions, each of which includes a one-hour presentation on obesity. Both simulations will be followed by standard Debriefing for Meaningful Learning segments, but these segments will focus only on the medical conditions and risk factors of obesity and no feedback on communication skills will be provided. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Nursing students aged 18-35
- Nursing students during their second or fourth year of the traditional or FLEX BSN undergraduate curriculum (in specified nursing courses)
Key exclusion criteria (4 listed)
- Non-nursing students
- Nursing students taking courses out of the normal curriculum sequence
- Nursing students who are not of traditional undergraduate ages (18-35 years)
- Students who decline to consent
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 |
|---|---|---|
| BRAVEIn addition to the two simulation encounters, the BRAVE arm will include an initial one-hour educational presentation on weight bias in health care; prevalence, and influences of weight bias on health/health care, factors affecting obesity, approaching weight-related discussions with patients with sensitivity and empathy, and effective communication strategies. Clinical communication behaviors will also be taught, such as asking permission, using non-stigmatizing language, and engaging in judgment-free weight-related discussions with patients. They will also have role-play and case-study scenarios to integrate and practice the communication strategies. Following the second simulation and DML, students in the BRAVE arm will participate in a continuation of the weight bias reduction education including concepts of Motivational Interviewing, Shared Decision Making, and weight management conversations to prevent weight bias in the clinical environment. | Behavioural | BRAVE Intervention |
| SOL: Standard Obesity LectureSOL: (Standard Obesity Lecture) SOL arm education will include a presentation on obesity as a disease, its prevalence, causes, health risks, psychological and socioeconomic impact, and a standard obesity assessment. Following the second simulation, students in the SOL groups will participate in a continuation of the standard obesity education to build on concepts from session 1. The second presentation will be a recap on weight management in clinical practice. Readings will focus on the medical consequences of obesity, and the economic cost of obesity. Both Debriefing for Meaningful Learning segments will focus on the disease itself and not include components of obesity or body weight. | Behavioural | SOL |
Primary outcome
Attitudes Towards Higher Weight Persons (ATOP-HW)
Time frame: Baseline to 3 Months
Estimated Mean Change Score.The ATOP-HW is a 20-item Likert rating scale that focuses on perceptions and attitudes about people living with obesity. Higher scores reflect more positive attitudes toward persons with obesity.
Beliefs About Obese Persons Scale (BAOP)
Time frame: Baseline to 3 Months
The BAOP is an eight-item Likert rating scale that assesses beliefs about the causes of obesity. Each question asks individuals to indicate the extent of agreement or disagreement (+3 to -3) to a specific statement, such as "obesity is really caused by a lack of willpower." Higher scores indicate beliefs that obesity is not controllable.
SE-12 (Self-Efficacy) Scale
Time frame: Baseline to 3 Months
The SE-12 is a 12-item questionnaire assessing self-efficacy by clinicians in clinical communications.
5 secondary outcomes
SEGUE Framework
Time frame: Baseline and 3 Months
Weight Sensitivity Instrument (WSI)
Time frame: Baseline and 3 Months
Attitudes Towards Higher Weight Persons (ATOP-HW) Questionnaire
Time frame: Baseline to 1 Year; 3 months to 1 Year
Beliefs About Obese Persons Scale (BAOP)
Time frame: Baseline to 1 Year; 3 months to 1 year
SE-12 (Self-Efficacy) Questionnaire
Time frame: Baseline to 1 year; 3 months to 1 year
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 17 Jul 2026.
- Background: PubMed 30346923Geller G, Watkins PA. Addressing Medical Students' Negative Bias Toward Patients With Obesity Through Ethics Education. AMA J Ethics. 2018 Oct 1;20(10):E948-959. doi: 10.1001/amajethics.2018.948.
- Background: PubMed 28759091Gayer GG, Weiss J, Clearfield M. Fundamentals for an Osteopathic Obesity Designed Study: The Effects of Education on Osteopathic Medical Students' Attitudes Regarding Obesity. J Am Osteopath Assoc. 2017 Aug 1;117(8):495-502. doi: 10.7556/jaoa.2017.099.
- Background: PubMed 30605364Charlesworth TES, Banaji MR. Patterns of Implicit and Explicit Attitudes: I. Long-Term Change and Stability From 2007 to 2016. Psychol Sci. 2019 Feb;30(2):174-192. doi: 10.1177/0956797618813087. Epub 2019 Jan 3.
- Background: PubMed 32033617Bell ML, Rabe BA. The mixed model for repeated measures for cluster randomized trials: a simulation study investigating bias and type I error with missing continuous data. Trials. 2020 Feb 7;21(1):148. doi: 10.1186/s13063-020-4114-9.
- Background: PubMed 11602365Makoul G. The SEGUE Framework for teaching and assessing communication skills. Patient Educ Couns. 2001 Oct;45(1):23-34. doi: 10.1016/s0738-3991(01)00136-7.
- Background: PubMed 27756291Axboe MK, Christensen KS, Kofoed PE, Ammentorp J. Development and validation of a self-efficacy questionnaire (SE-12) measuring the clinical communication skills of health care professionals. BMC Med Educ. 2016 Oct 18;16(1):272. doi: 10.1186/s12909-016-0798-7.
- BackgroundAllison, D.B., Basile, V.C., & Yuker, H.E. (1991). The measurement of attitudes toward and beliefs about obese persons. International Journal of Eating Disorders, 10(5). 599-607
- BackgroundDreifuerst, K. T. (2015). Getting started with debriefing for meaningful learning. Clinical Simulation in Nursing, 11(5), 268-275. http://dx.doi.org/10.1016/j.ecns.2015.01.005
- BackgroundDouglas, V.J., Kwan, M.Y., Minnich, A.M., Converse, J.N., Wonderlich, J.A., & Gordon, K.H. (2022). An examination of the link between empathy and weight-based victimization. Social Sciences & Humanities Open, 5(1), 100247 https://doi.org/10.1016/j.ssaho.2022.100247
- Background: PubMed 25674910Burke SE, Dovidio JF, Przedworski JM, Hardeman RR, Perry SP, Phelan SM, Nelson DB, Burgess DJ, Yeazel MW, van Ryn M. Do Contact and Empathy Mitigate Bias Against Gay and Lesbian People Among Heterosexual First-Year Medical Students? A Report From the Medical Student CHANGE Study. Acad Med. 2015 May;90(5):645-51. doi: 10.1097/ACM.0000000000000661.
- BackgroundDovidio, J.F., Gaertner, S.L., & Kawakami, K. (2003). Intergroup contact: the past, present, and future. Group Process Intergroup Relations, 6, 5-21.
- Background: PubMed 16737372Pettigrew TF, Tropp LR. A meta-analytic test of intergroup contact theory. J Pers Soc Psychol. 2006 May;90(5):751-83. doi: 10.1037/0022-3514.90.5.751.
- 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 BRAVE and SOL: Standard Obesity Lecture in people with Weight Bias, run by Villanova University at 1 site in United States.
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 4 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 17 Jul 2026. 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 United States. 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. Some participants in this study may receive a placebo. 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 Tracy L. Oliver, PhD, RDN, LDN (610-519-4917, tracy.oliver@villanova.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attitudes Towards Higher Weight Persons (ATOP-HW) (time frame: Baseline to 3 Months). The study lists 3 primary outcomes in all. 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 NCT07334470, which also lists 62 linked publications.
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 17 Jul 2026.