Weight Bias Reducation Intervention With Nursing Students Using Simulation: The BRAVE Study

January 10, 2026 updated by: Villanova University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

368

Phase

  • 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 Locations

  • United States
    • Pennsylvania
      • Villanova, Pennsylvania, United States, 19085-1603
        • Villanova University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tracy L Oliver, PhD, RDN, LDN
        • Sub-Investigator:
          • Gail Furman, PhD, RN, CHSE - A
        • Sub-Investigator:
          • Bette Mariani, PhD, RN, ANEF, FAAN
        • Sub-Investigator:
          • Margaret Brace, PhD
        • Sub-Investigator:
          • Rebecca Shenkman, MPH, RDN, LDN
        • Sub-Investigator:
          • Lisa Diewald, MS, RDN, LDN

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Nursing students aged 18-25
  • Nursing students during their second or fourth year of the traditional or FLEX BSN undergraduate curriculum (in specified nursing courses)

Exclusion Criteria:

  • Non-nursing students
  • Nursing students taking courses out of the normal curriculum sequence
  • Nursing students who are not of traditional undergraduate ages (18-25 years)
  • Students who decline to consent

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BRAVE Intervention
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.
Behavioral: BRAVE
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.
Placebo Comparator: SOL
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.
Behavioral: SOL: Standard Obesity Lecture
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 3 Months
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.
Baseline to 3 Months
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.
Baseline to 3 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SEGUE Framework
Time Frame: Baseline and 3 Months
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.
Baseline and 3 Months
Weight Sensitivity Instrument (WSI)
Time Frame: Baseline and 3 Months
The WSI is a 15-item checklist that will assess aspects of physical assessment skills, patient psychological safety, and weight sensitivity of the session.
Baseline and 3 Months
Attitudes Towards Higher Weight Persons (ATOP-HW) Questionnaire
Time Frame: Baseline to 1 Year; 3 months to 1 Year
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.
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
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
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
The SE-12 is a 12-item questionnaire assessing self-efficacy by clinicians in clinical communications.
Baseline to 1 year; 3 months to 1 year

Collaborators and Investigators

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

Sponsor

Villanova University

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 (Estimated)

January 12, 2026

Primary Completion (Estimated)

May 20, 2028

Study Completion (Estimated)

May 20, 2028

Study Registration Dates

First Submitted

December 30, 2025

First Submitted That Met QC Criteria

December 30, 2025

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 10, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-FY2025-30

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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