ObesityValid-OBNCT05804292
Psychometric Proprieties and Validation of Self-report Measures of Eating Behaviors
An observational study of Obesity and Eating Disorders, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Eating Disorders
- What is being tested?
- Questionnaire administration
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 15 Mar 2021to 15 Dec 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with obesity with/without an eating disorder AND the general population (non clinical)
Who may be able to join
- 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
Who cannot join
- visual impairing
- neurological problems
- alcohol/drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Eating Disorders
- Being tested
- Questionnaire administration
- Medical subject headings
- Obesity, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire administrationOther
Questionnaire administration
| Study group | Role | What they receive |
|---|---|---|
| Community sample | Questionnaires administration Receives: Other: Questionnaire administration | |
| Subjects with obesity and comorbid eating disorder | Questionnaires administration Receives: Other: Questionnaire administration | |
| Subjects with obesity without comorbid eating disorder | Questionnaires administration Receives: Other: Questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start15 Mar 2021
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giada Pietrabissa, PhD, Principal investigator, IRCCS Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804292
- Sponsor's protocol ID
- 03C020
- Acronym
- Valid-OB
- Status last verified
- Mar 2023
- First submitted
- 15 Mar 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Proprieties and Validation of Self-report Measures of Eating Behaviors in Persons With Obesity and the General Population in Italy.
- ClinicalTrials.gov ID
- NCT05804292
- Acronym / sponsor ID
- Valid-OB / 03C020
- Conditions
- Obesity, Eating Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Community sample | – | Other: Questionnaire administrationQuestionnaires administration |
| Subjects with obesity and comorbid eating disorder | – | Other: Questionnaire administrationQuestionnaires administration |
| Subjects with obesity without comorbid eating disorder | – | Other: Questionnaire administrationQuestionnaires administration |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with obesity with/without an eating disorder AND the general population (non clinical)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- visual impairing
- neurological problems
- alcohol/drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire administrationQuestionnaire administration | Other | Community sample, Subjects with obesity and comorbid eating disorder, Subjects with obesity without comorbid eating disorder |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giada Pietrabissa, PhD principal investigator
IRCCS Istituto Auxologico Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Eating Disorders, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binge Eating (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.