- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05804292
Psychometric Proprieties and Validation of Self-report Measures of Eating Behaviors (Valid-OB)
Psychometric Proprieties and Validation of Self-report Measures of Eating Behaviors in Persons With Obesity and the General Population in Italy.
Obesity is a global epidemic and a major contributor to some of the leading causes of death.
Although research on overweight and obesity is constantly increasing, to date, in the Italian panorama, there is a lack of (A) rigorous psychological measurement tools of obesity-related constructs and (B) analysis of the relationships between constructs (and indicators) involved in the development and maintenance of overweight and obesity.
The present study aims to examine the psychometric properties of the main questionnaires for the assessment of eating behaviors in 3 groups of subjects (1) the general population (control group); (2) subjects with obesity without a comorbid diagnosis of an eating disorder; (3) subjects with obesity and a comorbid diagnosis of an eating disorder.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants were selected in the main rehabilitation centers for the treatment of obesity and eating disorders (sample of subjects with obesity) and through an online survey (community sample). The survey lasted about 30 minutes and - together with selected demographic and biomedical information - required the completion of the following self-report measures: the Binge Eating Scale (BES); the Modified Yale Food Addiction Scale version 2 (mYFAS 2.0); the Repetitive eating questionnaire (Rep-EAT); the Measure of Eating Compulsivity (MEC); the Addiction-like Eating Behavioural Scale (AEBS); the Three Factor Eating Questionnaire 18 (TFEQ-18); the Eating Disorders Examination Questionnaire-Short Form (EDEQ-SF); the Palatable Eating Motive Scale (PEMS); the Weight Sigma Questionnaire (WSSQ); the Emotional Eating Scale (EES); the Somatic Symptom Scale 8 (SSS8).
Before administration, all questionnaires were first translated from English (their original language) to Italian by two bilingual translators, independently - then back-translated into English by another independent translator whose mother tongue was English to ensure equivalence between the translations. Following, a purposive sample of respondents was asked to fill in the final version of each measure in order to assess its items' comprehensibility.
In order to avoid halo effects, the questionnaires were presented to the subject in random order.
The responders could withdraw the administration at any time, and contact a psychologist independent from the study in case of perceived emotional distress.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Milan, Italy, 20145
- Istituto Auxologico Italiano
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- BMI > 30 kg/m2 (clinical sample)
- Diagnosis of an eating disorder (clinical sample)
- age range 18-75 years
- Italian mother tongue
- written and informed consent to participate
Exclusion Criteria:
- visual impairing
- neurological problems
- alcohol/drug abuse
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Community sample
Questionnaires administration
|
Questionnaire administration
|
|
Subjects with obesity and comorbid eating disorder
Questionnaires administration
|
Questionnaire administration
|
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Subjects with obesity without comorbid eating disorder
Questionnaires administration
|
Questionnaire administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Binge Eating
Time Frame: Baseline
|
Score on the Binge Eating Scale.
Each question has 3-4 separate responses assigned a numerical value.
The score range is from 0-46: Non-binging; less than 17; Moderate binging; 18-26; Severe binging; 27 and greater
|
Baseline
|
|
Food Addiction
Time Frame: Baseline
|
Scored on the Modified Yale Food Addiction Scale version 2 and at the Addiction-like Eating Behavioural Scale The "symptom count" score, ranging from 0 to 7, that reflects the number of addiction-like criteria endorsed was applied
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Giada Pietrabissa, PhD, IRCCS Istituto Auxologico Italiano
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03C020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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