Metacognitive Beliefs in Obese Patients

NCT06800911 | Recruiting

• 1 other identifier: 01C415
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to investigate the presence of metacognitive beliefs, emotional regulation, and emotional eating in obese patients and their possible relationships.

Conditions

Obesity

Keywords

Metabeliefs; Metacognition; Rumination; Dysfunctional lifestyle; Rehabilitation

Outcome Measures

Primary Outcomes (5)

• 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).

  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).

  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).

  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).

  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)

  Baseline

Study Arms (1)

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).

Other: Questionnaires

Interventions

Questionnaires OTHER

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

Obesity

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Age: between 18 and 65 years
• Italian nationality
• Body Mass Index ≥ 35 kg/m2

You may not qualify if:

• Psychiatric pathologies
• Severe cognitive deficits that could compromise the completion of the questionnaires
• Absence of signed informed consent

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Istituto Auxologico Italiano IRCCS, Site Piancavallo

Oggebbio, Verbania, 28824, Italy

RECRUITING

MeSH Terms

Conditions

Obesity; Rumination Syndrome

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Alessandro Sartorio, MD

CONTACT

+390261911; sartorio@auxologico.it

Luca Grappiolo, Dr.

CONTACT

+390261911; luca.grappiolo@auxologico.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 30, 2025
• Study Start: May 28, 2024
• Primary Completion: May 31, 2026
• Study Completion: May 31, 2026
• Last Updated: January 30, 2025

Record last verified: 2025-01

Locations

IT (1)