NCT07334470

Brief 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 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
368

participants targeted

Target at P75+ for not_applicable

Timeline
25mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Jan 2026May 2028

First Submitted

Initial submission to the registry

December 30, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

January 12, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2028

Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

2.4 years

First QC Date

December 30, 2025

Last Update Submit

January 10, 2026

Conditions

Keywords

weight biasnursing educationobesity

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Baseline to 3 Months

Secondary Outcomes (5)

  • SEGUE Framework

    Baseline and 3 Months

  • Weight Sensitivity Instrument (WSI)

    Baseline and 3 Months

  • Attitudes Towards Higher Weight Persons (ATOP-HW) Questionnaire

    Baseline to 1 Year; 3 months to 1 Year

  • Beliefs About Obese Persons Scale (BAOP)

    Baseline to 1 Year; 3 months to 1 year

  • SE-12 (Self-Efficacy) Questionnaire

    Baseline to 1 year; 3 months to 1 year

Study Arms (2)

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.

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.

Behavioral: SOL: Standard Obesity Lecture

Interventions

BRAVEBEHAVIORAL

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.

BRAVE Intervention

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.

SOL

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Villanova University

Villanova, Pennsylvania, 19085-1603, United States

Location

Related Publications (62)

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MeSH Terms

Conditions

Weight PrejudiceObesity

Condition Hierarchy (Ancestors)

PrejudiceSocial BehaviorBehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Tracy L. Oliver, PhD, RDN, LDN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2025

First Posted

January 12, 2026

Study Start

January 12, 2026

Primary Completion (Estimated)

May 20, 2028

Study Completion (Estimated)

May 20, 2028

Last Updated

January 13, 2026

Record last verified: 2026-01

Locations