NCT Number: NCT07334470
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.
Interested in participating?
Request Info18 year–35 year
All sexes
Interventional
Not applicable
Villanova, Pennsylvania, 19085-1603, United States
Location status: Recruiting
Bette Mariani, PhD, RN, ANEF, FAAN
CONTACT
Bette Mariani, PhD, RN, ANEF, FAAN
SUB_INVESTIGATOR
Gail Furman, PhD, RN, CHSE - A
SUB_INVESTIGATOR
Lisa Diewald, MS, RDN, LDN
SUB_INVESTIGATOR
Margaret Brace, PhD
SUB_INVESTIGATOR
Rebecca Shenkman, MPH, RDN, LDN
SUB_INVESTIGATOR
Tracy L Oliver, PhD, RDN, LDN
PRINCIPAL_INVESTIGATOR
Tracy Oliver, PhD, RDN, LDN
CONTACT
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.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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.
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.
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.
Time frame: Baseline to 3 Months
The SE-12 is a 12-item questionnaire assessing self-efficacy by clinicians in clinical communications.
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.
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.
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.
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
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.
Contact information is provided by the study sponsor or research team.
Villanova University
Other
The BRAVE Study: A Sensitivity Intervention With Nursing Students Using Simulation
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