Valid-OB: Psychometric Proprieties and Validation of Self-report Measures of Eating Behaviors

Sponsor
Istituto Auxologico Italiano (Other)
Overall Status
Completed
CT.gov ID
NCT05804292
Collaborator
(none)
300
1
21
14.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire administration

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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Psychometric Proprieties and Validation of Self-report Measures of Eating Behaviors in Persons With Obesity and the General Population in Italy.
Actual Study Start Date :
Mar 15, 2021
Actual Primary Completion Date :
Dec 15, 2022
Actual Study Completion Date :
Dec 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Community sample

Questionnaires administration

Other: Questionnaire administration
Questionnaire administration

Subjects with obesity and comorbid eating disorder

Questionnaires administration

Other: Questionnaire administration
Questionnaire administration

Subjects with obesity without comorbid eating disorder

Questionnaires administration

Other: Questionnaire administration
Questionnaire administration

Outcome Measures

Primary Outcome Measures

  1. Binge Eating [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

  2. Food Addiction [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istituto Auxologico Italiano Milan Italy 20145

Sponsors and Collaborators

  • Istituto Auxologico Italiano

Investigators

  • Principal Investigator: Giada Pietrabissa, PhD, IRCCS Istituto Auxologico Italiano

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Istituto Auxologico Italiano
ClinicalTrials.gov Identifier:
NCT05804292
Other Study ID Numbers:
  • 03C020
First Posted:
Apr 7, 2023
Last Update Posted:
Apr 7, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2023