NCT05804292

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 7, 2023

Completed
Last Updated

April 7, 2023

Status Verified

March 1, 2023

Enrollment Period

1.8 years

First QC Date

March 15, 2023

Last Update Submit

March 26, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Binge Eating

    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

    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

Study Arms (3)

Community sample

Questionnaires administration

Other: Questionnaire administration

Subjects with obesity and comorbid eating disorder

Questionnaires administration

Other: Questionnaire administration

Subjects with obesity without comorbid eating disorder

Questionnaires administration

Other: Questionnaire administration

Interventions

Questionnaire administration

Community sampleSubjects with obesity and comorbid eating disorderSubjects with obesity without comorbid eating disorder

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects with obesity with/without an eating disorder AND the general population (non clinical)

You may qualify if:

  • 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

You may not qualify if:

  • visual impairing
  • neurological problems
  • alcohol/drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano

Milan, 20145, Italy

Location

MeSH Terms

Conditions

ObesityFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveMental Disorders

Study Officials

  • Giada Pietrabissa, PhD

    IRCCS Istituto Auxologico Italiano

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2023

First Posted

April 7, 2023

Study Start

March 15, 2021

Primary Completion

December 15, 2022

Study Completion

December 15, 2022

Last Updated

April 7, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations