Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-28 @ 12:29 PM
Study NCT ID:
NCT06085092
Status:
RECRUITING
Last Update Posted:
2025-09-23
First Post:
2023-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open vs. Blind Weighing Study In Adolescents and Young Adult With Eating Disorders
Sponsor:
Milton S. Hershey Medical Center
Organization:
Study Overview
Official Title:
Evaluating Open Weighing and Blind Weighing in the Treatment of Adolescents and Young Adults With Eating Disorders
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: