Building Healthy Eating and Self-Esteem Together for University Students

NCT07060534 | Recruiting DMC

• 2 other identifiers: STUDY00144380R34MH134930-01A1
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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

Eating Disorders (Excluding Anorexia Nervosa); Binge-Eating Disorder

Keywords

Eating disorders; Bulimia nervosa; Binge-eating disorder; College Students; Purging disorder

Outcome Measures

Primary Outcomes (2)

• Binge eating and total number of eating disorder symptoms measured through the Eating Pathology Symptoms Inventory

  The EPSI is a well-validated self-report questionnaire measuring disordered eating symptoms appropriate for use across the weight spectrum and across several demographic groups.

  Baseline, 12-week intervention (weekly), and 3- and 6-month follow-ups

• BEST-U Daily Behavior Survey

  Includes self-report of number of daily behaviors, such as binge eating episodes and meal skipping

  12-week intervention (daily)

Secondary Outcomes (4)

• Clinical Impairment Assessment

  Baseline, Week 12, and 3- and 6-month follow-ups

• GAD-7

  Intake, Week 12, 3-month, 6-month follow up.

• PHQ-9

  Intake, Week 12, 3-month follow up, 6-month follow up.

• IDAS-II Dysphoria

  Weeks 1-11

Other Outcomes (10)

• Body Mass Index (BMI)

  Baseline, Weeks 1-12, and 3- and 6-month follow-ups

• Quick SCID for DSM-5 Disorders

  Baseline

• EPSI- Clinician Rated Version

  Baseline

Study Arms (2)

Present-Centered Therapy

EXPERIMENTAL

PCT is a brief intervention that focuses on building adaptive responses to current life stressors that are directly or indirectly related to psychopathology. PCT focuses on resolving interpersonal disconnection through the development of a positive therapeutic relationship, encouraging connection with others, and addressing interpersonal concerns. We chose PCT as a comparator because it targets daily life stressors, which are important triggers of negative emotions and emotion dysregulation that lead to binge-eating and other eating-disorder symptoms.

Behavioral: Present-Centered Therapy

BEST-U intervention

EXPERIMENTAL

Building Healthy Eating and Self-Esteem Together for University Students (BEST-U) is a transdiagnostic guided self-help ED treatment for adults that uses evidence-based principles to modify unhelpful thoughts and behaviors that maintain ED and trauma-related psychopathology. The program consists of 15 brief modules delivered each week over 12 sessions. Modules take approximately 10 minutes to complete and focus on key information/lessons that are short and interactive. BEST-U leverages frequent assessment to increase awareness of, and target, problem behaviors. Users reinforce their learning through weekly 25-30-minute telehealth "coaching" sessions, to review module material, problem-solve, practice skills, and plan homework exercises. BEST-U modules and coaching sessions utilize lessons and exercises drawn from Cognitive Behavioral Therapy Enhanced (CBT-E), traditional Cognitive Behavioral Therapy (CBT), and Dialectical Behavior Therapy (DBT).

Behavioral: Building Healthy Eating and Self-Esteem Together for University Students

Interventions

Building Healthy Eating and Self-Esteem Together for University Students BEHAVIORAL

Building Healthy Eating and Self-Esteem Together for University Students (BEST-U) is an mHealth program that includes modules based on second- and third-wave behavior therapy deployed through a smart phone app paired with 20-30-minute coaching sessions. BEST-U incorporates a range of evidence-based skills, and the electronic format allows coaches immediate and easy access to participant reports. BEST-U provides a comprehensive all-in-one assessment and intervention package, is easy-to-implement, brief, and has been tested across genders and in diverse ages and ethnic groups. BEST-U, therefore, has the potential to deliver effective, time-limited, interventions applicable to all university students in routine student healthcare settings.

BEST-U intervention

Present-Centered Therapy BEHAVIORAL

Present-Centered Therapy (PCT) is a brief intervention that focuses on building adaptive responses to current life stressors that are directly or indirectly related to psychopathology. PCT focuses on resolving interpersonal disconnection through the development of a positive therapeutic relationship, encouraging connection with others, and addressing interpersonal concerns. PCT was originally developed as a "placebo" intervention for post-traumatic stress disorder but is significantly more efficacious than wait-list in reducing psychiatric symptoms.

Present-Centered Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Student enrolled at KU.
• Bulimia nervosa (BN) or binge-eating disorder (BED) (or sub-threshold BN or BED).
• Access to a smartphone.
• No uncorrected vision problems that would interfere with ability to participate in the study.
• Students taking psychotropic medications must be on a stable therapeutic dose for four weeks prior to study enrollment.
• Able to read and speak fluent English.

You may not qualify if:

• Presence of current moderate/severe suicidal ideation with active intent.
• Significant psychopathology that could interfere with treatment (e.g., current substance-use disorder or psychosis).
• Medical conditions or medications that could interfere with treatment (e.g., Type 1 diabetes mellitus, cancer, current pregnancy or nursing, taking corticosteroids, etc.).
• Lab abnormalities indicating medical instability (e.g., low heart rate, electrolyte disturbance, acute medical complications of malnutrition) or another medical problem that would prevent outpatient care as determined through physical health assessment by the student's local clinician.
• Already receiving therapy for an ED.
• Positive screen for anorexia nervosa (AN), atypical AN (AAN), and/or low body weight (i.e., BMI \< 19.5) or avoidant and restrictive food intake disorder (ARFID).

Sponsors & Collaborators

• University of Kansas: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Kansas, Wakarusa Research Facility

Lawrence, Kansas, 66045, United States

RECRUITING

MeSH Terms

Conditions

Feeding and Eating Disorders; Binge-Eating Disorder; Bulimia Nervosa

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Kelsie Forbush, PhD

  University of Kansas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelsie Forbush, PhD

CONTACT

785-864-6525; kforbush@ku.edu

Kara Christensen-Pacella Assistant Professor, PhD

CONTACT

702-895-2279; kara.christensen@unlv.edu

Study Design

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

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 11, 2025
• Study Start (Estimated): June 23, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 14, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: All data will be deposited to NDA starting 12 months after the award begins and will be deposited every six months thereafter following the usual NDA data submission dates.
• Access Criteria: The research community will have access to data when the award ends. As required by NDA, studies will also be created that contain the data used for every publication. Those studies will be shared when the pre-print is available. NDA studies have digital object identifiers (DOI) to aid in findability. We will include that DOI in relevant publications. NDA will make decisions about how long to preserve the data, but that data archive has not deleted any deposited data up to now.

Locations

US (1)