Open vs. Blind Weighing Study In Adolescents and Young Adult With Eating Disorders

BEHAVIORAL

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.

BEHAVIORAL

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.

Eating Disorder Examination - Self-Report Questionnaire (EDE-Q)

Time frame: Admission-Baseline

The Eating Disorder Examination Questionnaire (EDE-Q) is a 28-item self-report questionnaire. It was designed to assess the range, frequency, and severity of behaviors associated with a diagnosis of an eating disorder. A total score is obtained by summing the four subscales scores and dividing the total by the number of subscales. The score of items are calculated and range from 0 to 36. The higher score indicate greater ED symptoms.

Fear of Food Measure (FOFM)

Time frame: Admission Baseline

The Fear of Food Measure (FORM) is a 23-item self-report questionnaire. It examines the participant's severity of behaviors associated with a diagnosis of an eating disorder. Each item is scored on a 1-7 scale. The questionnaire range from 23 to 161 meaning 23: no fear of food and 161 meaning severe fear of food.

Body Shape Questionnaire (BSQ)

Time frame: Admission- Baseline

The BSQ is a self-reported measurement of the body shape concerns typical of bulimia nervosa and anorexia nervosa. The questionnaire has 34 items scored from 0 to 6 points (least and most impaired, respectively), with the sum of the questions giving a range from 0 to 204.

Clinical Impairment Assessment (CIA)

Time frame: Admission- Baseline

The Clinical Impairment Assessment Questionnaire (CIA) is a 16-item self-report measure of the severity of psychosocial impairment due to eating disorder features and focuses on the past 28 days. The 16 items cover impairment in domains of life that are typically affected by eating disorder psychopathology: mood and self-perception, cognitive functioning, interpersonal functioning, and work performance. The response are scored 0,1,2 and 3 with a higher rating indicating a higher level of impairment. The total range is between 0 and 48.

Eating Disorder Fear Questionnaire (EDFQ)

Time frame: Admission_Baseline

The Eating Disorder Fear Questionnaire (EDFQ) is a 20-item self-report questionnaire. It examines the participant's severity of behaviors associated with a diagnosis of an eating disorder. The response range between 1 to 7 with a total range of 20 to 140. The higher rating indicating a higher severe impairment.

Eating Disorder-15 (ED 15)

Time frame: Admission_Baseline

The Eating Disorder-15 (ED-15) is a 15-item measure designed to assess eating psychopathology levels over the preceding week. The 10 items scored from 0 to 6 points (least and most impaired, respectively), with the sum of the questions giving a range from 0 to 6. The additional 5 items focused on the number of days individuals participated in a given behavior, such as the use of laxatives and restrictive eating.

Body Image States Scale (BISS)

Time frame: Admission_Baseline

The Body Image State Scale (BISS) is a 6-item measure designed to assess body dissatisfaction. The questionnaire is rated on a seven-point scale ranging from "very satisfied" to very dissatisfied".

Approach / Avoidance of weighing Questionnaire (AAWQ)

Time frame: Admission_Baseline

The Approach / Avoidance of Weighing Questionnaire (AAWQ) is a 9-item measure designed to assess approach and avoidance weighing tendency. The three descriptive items are not included in the approach/avoidance weighing tendencies calculation. Items 1-3 correspond to approach weighing tendency, and items 4-6 correspond to avoidance weighing tendency. Items are scored as follows for both subscales: Totally true of me = 5; Somewhat true of me = 4; Neither true nor untrue of me = 3; Somewhat untrue of me = 2; Totally untrue of me = 1. Items 1-3 are summed to provide the approach weighing tendency subscale and items 4-6 are summed to provide the avoidance weighing tendency subscale, with scores ranging from 3-15. Higher scores on each subscale indicate a higher degree of that subscale's weighing tendency.

Eating Disorder Examination - Self-Report Questionnaire (EDE-Q)

Time frame: Discharge: No longer than 60 weeks

The Eating Disorder Examination Questionnaire (EDE-Q) is a 28-item self-report questionnaire. It was designed to assess the range, frequency, and severity of behaviors associated with a diagnosis of an eating disorder. A total score is obtained by summing the four subscales scores and dividing the total by the number of subscales. The score of items are calculated and range from 0 to 36. The higher score indicate greater ED symptoms.

Fear of Food Measure (FOFM)

Time frame: Discharge: No longer than 60 weeks

The Fear of Food Measure (FORM) is a 23-item self-report questionnaire. It examines the participant's severity of behaviors associated with a diagnosis of an eating disorder. Each item is scored on a 1-7 scale. The questionnaire range from 23 to 161 meaning 23: no fear of food and 161 meaning severe fear of food.

Body Shape Questionnaire (BSQ)

Time frame: Discharge: No longer than 60 weeks

The BSQ is a self-reported measurement of the body shape concerns typical of bulimia nervosa and anorexia nervosa. The questionnaire has 34 items scored from 0 to 6 points (least and most impaired, respectively), with the sum of the questions giving a range from 0 to 204.

Clinical Impairment Assessment (CIA)

Time frame: Discharge: No longer than 60 weeks

The Clinical Impairment Assessment Questionnaire (CIA) is a 16-item self-report measure of the severity of psychosocial impairment due to eating disorder features and focuses on the past 28 days. The 16 items cover impairment in domains of life that are typically affected by eating disorder psychopathology: mood and self-perception, cognitive functioning, interpersonal functioning, and work performance. The response are scored 0,1,2 and 3 with a higher rating indicating a higher level of impairment. The total range is between 0 and 48.

Eating Disorder Fear Questionnaire (EDFQ)

Time frame: Discharge: No longer than 60 weeks

The Eating Disorder Fear Questionnaire (EDFQ) is a 20-item self-report questionnaire. It examines the participant's severity of behaviors associated with a diagnosis of an eating disorder. The response range between 1 to 7 with a total range of 20 to 140. The higher rating indicating a higher severe impairment.

Eating Disorder-15 (ED-15)

Time frame: Discharge: No longer than 60 weeks

The Eating Disorder-15 (ED-15) is a 15-item measure designed to assess eating psychopathology levels over the preceding week. The 10 items scored from 0 to 6 points (least and most impaired, respectively), with the sum of the questions giving a range from 0 to 6. The additional 5 items focused on the number of days individuals participated in a given behavior, such as the use of laxatives and restrictive eating.

Body Image State Scale (BISS)

Time frame: Discharge: No longer than 60 weeks

The Body Image State Scale (BISS) is a 6-item measure designed to assess body dissatisfaction. The questionnaire is rated on a seven-point scale ranging from "very satisfied" to very dissatisfied".

Approach / Avoidance of Weighing Questionnaire (AAWQ)

Time frame: Discharge: No longer than 60 weeks

The Approach / Avoidance of Weighing Questionnaire (AAWQ) is a 9-item measure designed to assess approach and avoidance weighing tendency. The three descriptive items are not included in the calculation of approach/avoidance weighing tendencies. The items 1-3 correspond to approach weighing tendency, and items 4-6 correspond to avoidance weighing tendency. Items are scored as follows for both subscales: Totally true of me = 5; Somewhat true of me = 4; Neither true nor untrue of me = 3; Somewhat untrue of me = 2; Totally untrue of me = 1. Items 1-3 are summed to provide the approach weighing tendency subscale and items 4-6 are summed to provide the avoidance weighing tendency subscale, with scores ranging from 3-15. Higher scores on each subscale indicate a higher degree of that subscale's weighing tendency.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.