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临床试验/NCT07334470
NCT07334470招募中不适用

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

Villanova University1 个研究点 分布在 1 个国家目标入组 368 人开始时间: 2026年1月12日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
368
试验地点
1
主要终点
Attitudes Towards Higher Weight Persons (ATOP-HW)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: BRAVE (Behavioral)

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.

干预措施: SOL: Standard Obesity Lecture (Behavioral)

结局指标

主要结局

Attitudes Towards Higher Weight Persons (ATOP-HW)

时间窗: 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)

时间窗: 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

时间窗: Baseline to 3 Months

The SE-12 is a 12-item questionnaire assessing self-efficacy by clinicians in clinical communications.

次要结局

  • SEGUE Framework(Baseline and 3 Months)
  • Weight Sensitivity Instrument (WSI)(Baseline and 3 Months)
  • Beliefs About Obese Persons Scale (BAOP)(Baseline to 1 Year; 3 months to 1 year)
  • Attitudes Towards Higher Weight Persons (ATOP-HW) Questionnaire(Baseline to 1 Year; 3 months to 1 Year)
  • SE-12 (Self-Efficacy) Questionnaire(Baseline to 1 year; 3 months to 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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