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

Official title

The BRAVE Study: A Sensitivity Intervention With Nursing Students Using Simulation

Overview

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.

Interventions

• 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 judgme
• 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

Primary outcome measures

• Attitudes Towards Higher Weight Persons (ATOP-HW) [Time frame: Baseline to 3 Months]
• Beliefs About Obese Persons Scale (BAOP) [Time frame: Baseline to 3 Months]
• SE-12 (Self-Efficacy) Scale [Time frame: Baseline to 3 Months]

Secondary outcome measures (5)

• 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]

Eligibility criteria

Inclusion criteria

• 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)

Exclusion criteria

• Non-nursing students
• Nursing students taking courses out of the normal curriculum sequence
• Nursing students who are not of traditional undergraduate ages (18-35 years)
• Students who decline to consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Villanova University — Villanova

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. PMID 30346923
• Gayer 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. PMID 28759091
• Charlesworth 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. PMID 30605364
• Bell 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. PMID 32033617
• Makoul 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. PMID 11602365
• Axboe 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. PMID 27756291
• Allison, 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

Identifiers

NCT: NCT07334470 · IRB-FY2025-30

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗