Recruiting

Observational Study

Sponsor:

Milton S. Hershey Medical Center

Code:

NCT06085092

Conditions

Eating Disorders

Anorexia Nervosa

Eligibility Criteria

Sex: All

Age: 12 - 24

Healthy Volunteers: Not accepted

Interventions

Open weighing

Blind weighing

Study Details

Brief summary:

Current treatments for adolescents and young adults (AYAs) with eating disorders (EDs) do not effectively address a central ED symptom - anxiety about weight gain - which contributes to poor outcomes. The proposed study evaluates the feasibility, acceptability, efficacy, and underlying mechanisms of an enhanced version of "open weighing," a cognitive-behavioral intervention designed to target anxiety about weight gain in AYAs with EDs. Understanding how to better treat AYAs with EDs, and identifying the mechanisms by which interventions lead to improvement, will aid in the development of more effective and personalized treatments, ultimately improving the lives of AYAs with EDs.

Conditions

Eating Disorders

Anorexia Nervosa

Study ID

NCT06085092

Start date

Oct 31, 2023

Status verified date

Sep, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 24

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants must be English speakers.
  • Participants must be between the ages of 12 - 24 years who have been admitted to either the adolescent or young adult Partial Hospital Program (PHP) for eating disorders (EDs) at Penn State Hershey.
  • Participants must also present with an eating disorder (ED) diagnosis that is characterized by anxiety about weight gain, such as anorexia nervosa (AN), Bulimia nervosa (BN), or their subthreshold presentations captured under the other specific feeding or eating disorder (OSFED) category.

Exclusion Criteria:

  • Participants will be excluded if they are above the age of 24 or below the age of 12 years.
  • Participants who have been identified as non-English speakers.
  • Participants with cognitive impairment will also be excluded from participation.
  • Potential participants will be excluded if they do not meet the diagnostic inclusion criteria noted above.
  • individuals with a diagnosis of avoidant/restrictive food intake disorder, as these individuals do not experience anxiety about weight gain will be excluded.

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Open weighing

The open-weighing intervention aims to challenge beliefs about weight gain. The study coordinator (SC) will explain open weighing, discuss any concerns you have about your weight, and construct a weight graph with the number of weeks on the x-axis and weight in pounds on the y-axis. The SC will help identify beliefs about gaining weight, which will be written on a Feared Outcomes Form. The SC will ask you to predict your weight, mark the weight prediction on the graph, weigh you on a standing scale, record your weight, and discuss your responses to seeing your weight, including any reasons for a difference between your predicted and actual weight. Each week, the SC will graph your actual and predicted weights over time and discuss anything that you are learning from this process. The SC will ask you to complete the Feared Outcomes Form once per day over the next week, review it each week, and talk to you about what you are learning from this process.

active comparator: Blind weighing

The blind weighing intervention aims to help you see self-weighing as an eating disorder symptom that you should stop, and that weight is not important to your identity or selfesteem. To do this, the study coordinator will explain why blind weighing might be helpful. You will then be asked to step backwards on a standing scale. The study coordinator will record your weight, but will not share your weight information with you. The study coordinator will discourage you from thinking or talking about your weight.

Interventions

Open weighing

The open-weighing intervention aims to challenge beliefs about weight gain. The study coordinator (SC) will explain open weighing, discuss any concerns you have about your weight, and construct a weight graph with the number of weeks on the x-axis and weight in pounds on the y-axis. The SC will help identify beliefs about gaining weight, which will be written on a Feared Outcomes Form. The SC will ask you to predict your weight, mark the weight prediction on the graph, weigh you on a standing scale, record your weight, and discuss your responses to seeing your weight, including any reasons for a difference between your predicted and actual weight. Each week, the SC will graph your actual and predicted weights over time and discuss anything that you are learning from this process. The SC will ask you to complete the Feared Outcomes Form once per day over the next week, review it each week, and talk to you about what you are learning from this process.

Blind weighing

The blind weighing intervention aims to help you see self-weighing as an eating disorder symptom that you should stop, and that weight is not important to your identity or self-esteem. To do this, the study coordinator will explain why blind weighing might be helpful. You will then be asked to step backwards on a standing scale. The study coordinator will record your weight but will not share your weight information with you. The study coordinator will discourage you from thinking or talking about your weight.

Primary outcome measure

  • Eating Disorder Examination - Self-Report Questionnaire (EDE-Q) [ Time Frame: Admission-Baseline ]
  • Fear of Food Measure (FOFM) [ Time Frame: Admission Baseline ]
  • Body Shape Questionnaire (BSQ) [ Time Frame: Admission- Baseline ]
  • Clinical Impairment Assessment (CIA) [ Time Frame: Admission- Baseline ]
  • Eating Disorder Fear Questionnaire (EDFQ) [ Time Frame: Admission_Baseline ]
  • Eating Disorder-15 (ED 15) [ Time Frame: Admission_Baseline ]
  • Body Image States Scale (BISS) [ Time Frame: Admission_Baseline ]
  • Approach / Avoidance of weighing Questionnaire (AAWQ) [ Time Frame: Admission_Baseline ]
  • Eating Disorder Examination - Self-Report Questionnaire (EDE-Q) [ Time Frame: Discharge: No longer than 60 weeks ]
  • Fear of Food Measure (FOFM) [ Time Frame: Discharge: No longer than 60 weeks ]
  • Body Shape Questionnaire (BSQ) [ Time Frame: Discharge: No longer than 60 weeks ]
  • Clinical Impairment Assessment (CIA) [ Time Frame: Discharge: No longer than 60 weeks ]
  • Eating Disorder Fear Questionnaire (EDFQ) [ Time Frame: Discharge: No longer than 60 weeks ]
  • Eating Disorder-15 (ED-15) [ Time Frame: Discharge: No longer than 60 weeks ]
  • Body Image State Scale (BISS) [ Time Frame: Discharge: No longer than 60 weeks ]
  • Approach / Avoidance of Weighing Questionnaire (AAWQ) [ Time Frame: Discharge: No longer than 60 weeks ]

Central Contacts and Locations

Central contacts

Jamal Essayli, Ph.D

7175310003jessayli@pennstatehealth.psu.edu

Locations

905 W Govener Rd

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Jamal Essayli, Ph.D

717-531-0003jessayli@pennstatehealth.psu.edu

More Information

Sponsor

Milton S. Hershey Medical Center

Last update posted

Sep 23, 2025

Last verified

Sep, 2025

Keywords

  • Eating Disorders
  • Anorexia Nervosa

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Milton S. Hershey Medical Center on 2025-09-23.