- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06800911
Metacognitive Beliefs in Obese Patients (METAOBES)
January 24, 2025 updated by: Istituto Auxologico Italiano
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.
Study Overview
Study Type
Observational
Enrollment (Estimated)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alessandro Sartorio, MD
- Phone Number: 2426 +390261911
- Email: sartorio@auxologico.it
Study Contact Backup
- Name: Luca Grappiolo, Dr.
- Phone Number: 2894 +390261911
- Email: luca.grappiolo@auxologico.it
Study Locations
-
-
Verbania
-
Oggebbio, Verbania, Italy, 28824
- Recruiting
- Istituto Auxologico Italiano IRCCS, Site Piancavallo
-
Contact:
- Alessandro Sartorio, MD
- Phone Number: 2426 +39-02619111
- Email: sartorio@auxologico.it
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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).
Description
Inclusion Criteria:
- Age: between 18 and 65 years
- Italian nationality
- Body Mass Index ≥ 35 kg/m2
Exclusion Criteria:
- Psychiatric pathologies
- Severe cognitive deficits that could compromise the completion of the questionnaires
- Absence of signed informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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).
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Baseline
|
|
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).
|
Baseline
|
|
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).
|
Baseline
|
|
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).
|
Baseline
|
|
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)
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 28, 2024
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Study Registration Dates
First Submitted
January 24, 2025
First Submitted That Met QC Criteria
January 24, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 24, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 01C415
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.