ObesityMETAOBESNCT06800911
Metacognitive Beliefs in Obese Patients
An observational study of Obesity, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
The study aims to investigate the presence of metacognitive beliefs, emotional regulation, and emotional eating in obese patients and their possible relationships. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Questionnaires
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 28 May 2024to 31 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 90 patients aged between 18 and 65, of both sexes, of Italian nationality, suffering from obesity (Body Mass Index, BMI: kg/m2 ≥ 35, according to the criteria of the World Health Organization WHO).
Who may be able to join
- Age: between 18 and 65 years
- Italian nationality
- Body Mass Index ≥ 35 kg/m2
Who cannot join
- Psychiatric pathologies
- Severe cognitive deficits that could compromise the completion of the questionnaires
- Absence of signed informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Auxologico Italiano IRCCS, Site Piancavallo
Oggebbio, Verbania, 28824
Alessandro Sartorio, MD, +39-02619111 ext. 2426, sartorio@auxologico.it
About this study
Official title: Metacognitive Beliefs, Emotional Regulation in Obese Patients
The study aims to investigate the presence of metacognitive beliefs, emotional regulation, and emotional eating in obese patients and their possible relationships.
- Conditions
- Obesity
- Being tested
- Questionnaires
- Keywords
- Metabeliefs, Metacognition, Rumination, Dysfunctional lifestyle, Rehabilitation
- Medical subject headings
- Obesity, Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Metacognition Questionnaire Penn State Worry Questionnaire Ruminative Response Scale Anger Rumination scale Difficulties in Emotion Regulation Scale Emotional Eating subscale of the Dutch Eating Behavior Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Obesity | Patients aged between 18 and 65, of both sexes, of Italian nationality, suffering from obesity (Body Mass Index, BMI: kg/m2 ≥ 35, according to the criteria of the World Health Organization WHO). Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metacognitive beliefs
Metacognition Questionnaire (MCQ-30) is a self-report test composed of 30 items on a 4-point Likert scale from 1 (I do not agree) to 4 (I completely agree agreement).
Measured: Baseline
Rumination
Ruminative Response Scale (RRS) is a self-report test composed of 20 items on a 4-point Likert scale from 1 (almost never) to 4 (almost always).
Measured: Baseline
Anger Rumination
Anger Rumination scale (ARS) is a self-report test composed of 14 items, on a Likert scale from 1 (almost never) to 4 (almost always).
Measured: Baseline
Emotional dysregulation
Difficulties in Emotion Regulation Scale (DERS) isa self-report test composed of 36 items on a Likert scale from 1 (almost never) to 5 (almost always).
Measured: Baseline
Emotional eating
Emotional Eating subscale of the Dutch Eating Behavior Questionnaire (DEBQ), composed of 13 items on a Likert scale from 0 (never) to 4 (almost always)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start28 May 2024
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800911
- Sponsor's protocol ID
- 01C415
- Acronym
- METAOBES
- Status last verified
- Jan 2025
- First submitted
- 24 Jan 2025
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metacognitive Beliefs, Emotional Regulation in Obese Patients
- ClinicalTrials.gov ID
- NCT06800911
- Acronym / sponsor ID
- METAOBES / 01C415
- Conditions
- Obesity
- Keywords
- Metabeliefs, Metacognition, Rumination, Dysfunctional lifestyle, Rehabilitation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 28 May 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 30 Jan 2025 (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.
The study aims to investigate the presence of metacognitive beliefs, emotional regulation, and emotional eating in obese patients and their possible relationships.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obesity | – | Other: QuestionnairesPatients aged between 18 and 65, of both sexes, of Italian nationality, suffering from obesity (Body Mass Index, BMI: kg/m2 ≥ 35, according to the criteria of the World Health Organization WHO). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 90 patients aged between 18 and 65, of both sexes, of Italian nationality, suffering from obesity (Body Mass Index, BMI: kg/m2 ≥ 35, according to the criteria of the World Health Organization WHO).
Key inclusion criteria (3 listed)
- Age: between 18 and 65 years
- Italian nationality
- Body Mass Index ≥ 35 kg/m2
Key exclusion criteria (3 listed)
- Psychiatric pathologies
- Severe cognitive deficits that could compromise the completion of the questionnaires
- Absence of signed informed consent
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 |
|---|---|---|
| QuestionnairesMetacognition Questionnaire Penn State Worry Questionnaire Ruminative Response Scale Anger Rumination scale Difficulties in Emotion Regulation Scale Emotional Eating subscale of the Dutch Eating Behavior Questionnaire | Other | Obesity |
Primary outcome
Metacognitive beliefs
Time frame: Baseline
Metacognition Questionnaire (MCQ-30) is a self-report test composed of 30 items on a 4-point Likert scale from 1 (I do not agree) to 4 (I completely agree agreement).
Rumination
Time frame: Baseline
Ruminative Response Scale (RRS) is a self-report test composed of 20 items on a 4-point Likert scale from 1 (almost never) to 4 (almost always).
Anger Rumination
Time frame: Baseline
Anger Rumination scale (ARS) is a self-report test composed of 14 items, on a Likert scale from 1 (almost never) to 4 (almost always).
Emotional dysregulation
Time frame: Baseline
Difficulties in Emotion Regulation Scale (DERS) isa self-report test composed of 36 items on a Likert scale from 1 (almost never) to 5 (almost always).
Emotional eating
Time frame: Baseline
Emotional Eating subscale of the Dutch Eating Behavior Questionnaire (DEBQ), composed of 13 items on a Likert scale from 0 (never) to 4 (almost always)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
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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.
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, 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 3 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: looking for participants now, as of the sponsor's last update on 30 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Sartorio, MD (+390261911 ext. 2426, sartorio@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metacognitive beliefs (time frame: Baseline). The study lists 5 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 30 Jan 2025.