Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07060534

Building Healthy Eating and Self-Esteem Together for University Students

Led by University of Kansas · Updated on 2026-01-14

74

Participants Needed

1

Research Sites

79 weeks

Total Duration

On this page

Sponsors

U

University of Kansas

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Eating disorders (EDs) are a critical concern on college campuses. Moreover, since the COVID-19 pandemic, ED prevalence has increased by 62% in university women and 140% in university men. Resources are inadequate to meet demand, leading to delays in students' access to treatment. Untreated (or poorly treated) EDs result in greater healthcare utilization and costs to students, as well as lower academic achievement and increased psychiatric disability and mortality, suggesting a critical need for quality ED treatment on university campuses and to rethink treatment delivery. One way to address this gap in care delivery is to improve treatment accessibility and scalability, such as dissemination via mobile apps. Guided self-help Cognitive Behavior Therapy (CBT-gsh) is a cost-effective option that can be delivered by non-traditional service providers, such as nurses and physicians. Our scientific premise is that the mHealth CBT-gsh app, Building Healthy Eating and Self-Esteem Together for University Students (BEST-U), will lead to reductions in binge eating (primary outcome) through reductions in dietary restraint and weight/shape concerns (target mechanisms). Prior to implementing BEST-U at other universities, we need to test the intervention in a real-world setting with the end goal of disseminating at scale. Our objectives are to: 1) conduct an effectiveness test of BEST-U compared to a similar dose of present-centered therapy (PCT) in students with non-low weight binge-spectrum EDs and 2) test target mechanisms that lead to changes in binge eating. To accomplish our objectives, we will test the following specific aims: 1) conduct an RCT of BEST-U (N=37) compared to a similar dose of PCT (N=37) in students with non-low weight binge-spectrum EDs; 2) test target mechanisms that lead to changes in binge eating and other ED symptoms; and 3) characterize barriers and facilitators to implementation across two campuses. Our exploratory aim will test food reinforcement and food-choice impulsivity as potential target mechanisms or response moderators of rapid response in binge eating. Given that few studies have identified underlying mechanisms that explain how CBT-gsh works and for whom, this study may lead to improved ability to tailor or modify existing CBT-gsh or lead to novel intervention development for students who are unlikely to respond rapidly (or at all) to first line CBT interventions for EDs.

CONDITIONS

Official Title

Building Healthy Eating and Self-Esteem Together for University Students

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 60; 18 years.
  • Student enrolled at KU.
  • Diagnosis of bulimia nervosa, binge-eating disorder, or sub-threshold forms of these disorders.
  • Access to a smartphone.
  • No uncorrected vision problems that interfere with participation.
  • Stable dose of psychotropic medications for at least four weeks if applicable.
  • Ability to read and speak fluent English.
Not Eligible

You will not qualify if you...

  • Current moderate or severe suicidal thoughts with active intent.
  • Significant mental health issues interfering with treatment, such as substance-use disorder or psychosis.
  • Medical conditions or medications interfering with treatment, including Type 1 diabetes, cancer, pregnancy, nursing, or corticosteroid use.
  • Lab abnormalities indicating medical instability or other medical problems preventing outpatient care.
  • Already receiving therapy for an eating disorder.
  • Positive screen for anorexia nervosa, atypical anorexia nervosa, low body weight (BMI < 19.5), or avoidant/restrictive food intake disorder.

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Kansas, Wakarusa Research Facility

Lawrence, Kansas, United States, 66045

Actively Recruiting

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Research Team

K

Kelsie Forbush, PhD

CONTACT

K

Kara Christensen-Pacella Assistant Professor, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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