Clinical trial NCT06085092: Open vs. Blind Weighing Study In Adolescents and Young Adult With Eating Disorders
Official title: Evaluating Open Weighing and Blind Weighing in the Treatment of Adolescents and Young Adults With Eating Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Eating Disorders
Anorexia Nervosa
Keywords: Eating Disorders
Anorexia Nervosa
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 70
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The proposed study evaluates the feasibility, acceptability, efficacy, and underlying mechanisms of an enhanced version of "open weighing" (OW), a cognitive-behavioral intervention designed to target anxiety about weight gain in adolescents and young adults (AYAs) with eating disorders (EDs). OW will be compared to an alternative intervention, "blind weighing" (BW), in which individuals are discouraged from seeing, thinking, or talking about their weight. 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.

Aim 1. Evaluate the feasibility and acceptability of OW and BW for AYAs with EDs.

Hypothesis 1.1: Both OW and BW will be feasible, with no significant differences in rates of recruitment or retention.

Hypothesis 1.2: Both treatments will be rated as highly acceptable, with no significant differences in measures evaluating the acceptability or attitudes about OW and BW.

Aim 2. Test the efficacy of OW and BW. Hypothesis 2.1: OW will result in significantly greater improvements in body mass index and ED symptomatology than BW.

Hypothesis 2.2: OW will result in significantly greater decreases in anxiety about weight gain than BW.

Aim 3. Identify anxiety about weight gain as a key mechanism to target in the treatment of AYAs with EDs.

Hypothesis 3.1: Across both conditions, greater reductions in anxiety about weight gain will be associated with better outcomes at discharge.

Eligibility criteria: 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.

Primary outcomes:
measure: Eating Disorder Examination - Self-Report Questionnaire (EDE-Q)
timeFrame: Admission-Baseline
measure: Fear of Food Measure (FOFM)
timeFrame: Admission Baseline
measure: Body Shape Questionnaire (BSQ)
timeFrame: Admission- Baseline
measure: Clinical Impairment Assessment (CIA)
timeFrame: Admission- Baseline
measure: Eating Disorder Fear Questionnaire (EDFQ)
timeFrame: Admission_Baseline
measure: Eating Disorder-15 (ED 15)
timeFrame: Admission_Baseline
measure: Body Image States Scale (BISS)
timeFrame: Admission_Baseline
measure: Approach / Avoidance of weighing Questionnaire (AAWQ)
timeFrame: Admission_Baseline
measure: Eating Disorder Examination - Self-Report Questionnaire (EDE-Q)
timeFrame: Discharge: No longer than 60 weeks
measure: Fear of Food Measure (FOFM)
timeFrame: Discharge: No longer than 60 weeks
measure: Body Shape Questionnaire (BSQ)
timeFrame: Discharge: No longer than 60 weeks
measure: Clinical Impairment Assessment (CIA)
timeFrame: Discharge: No longer than 60 weeks
measure: Eating Disorder Fear Questionnaire (EDFQ)
timeFrame: Discharge: No longer than 60 weeks
measure: Eating Disorder-15 (ED-15)
timeFrame: Discharge: No longer than 60 weeks
measure: Body Image State Scale (BISS)
timeFrame: Discharge: No longer than 60 weeks
measure: Approach / Avoidance of Weighing Questionnaire (AAWQ)
timeFrame: Discharge: No longer than 60 weeks
Secondary outcomes:
measure: Personal Reactions to the Rationale questionnaire (PRR)
timeFrame: Admission-Baseline
measure: Credibility Scale (CS)
timeFrame: Admission-Baseline
Other outcomes:
Locations:
city: Hershey
country: United States
facility: 905 W Govener Rd
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Jamal Essayli, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: