NCT06800807

Brief Summary

The present study aims to study the presence of metacognitive beliefs in adolescent subjects with eating and nutrition disorders (END) compared with a control group composed of subjects of the same sex and age belonging to the general population.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Jun 2024Jun 2026

Study Start

First participant enrolled

June 26, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 30, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

January 24, 2025

Last Update Submit

March 25, 2026

Conditions

Keywords

metabeliefsmetacognitionbroodingruminationanorexia nervosabulimia nervosabinge eating disorder

Outcome Measures

Primary Outcomes (3)

  • Metacognitive beliefs

    Metacognition Questionnaire (MCQ-30; Cartwright-Hatton \& Wells, 1997), 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

  • Brooding

    Penn State Worry Questionnaire (PSWQ; Meyer et at., 1990), a self-report test composed of 16 items on a 5-point Likert scale from 1 (not at all typical) to 5 (very typical)

    Baseline

  • Rumination

    Ruminative Response Scale (RRS; Nolen-Hoeksema and Morrow, 1991), a self-report test composed of 20 items on a 4-point Likert scale from 1 (almost never) to 4 (almost always)

    Baseline

Study Arms (2)

Eating and nutrition disorders (END)

Female patients aged between 12 and 17 years, of Italian nationality, who present a diagnosis relating to the END framework according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).

Other: Observation of several factors involved in eating and nutrition disorders

Control group

Female subjects of the same age and of Italian nationality, belonging to the general population.

Other: Observation of several factors involved in eating and nutrition disorders

Interventions

Observation of symptomatology of eating and nutrition disorders, metacognitive beliefs, brooding and rumination.

Control groupEating and nutrition disorders (END)

Eligibility Criteria

Age12 Years - 17 Years
Sexfemale
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

36 patients aged between 12 and 17 years, females, of Italian nationality, who present a diagnosis relating to the END framework according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). These patients will be compared with a control group made up of 36 subjects of the same sex, age, and nationality, belonging to the general population.

You may qualify if:

  • Female sex
  • Age: 12 to 17 years
  • Italian nationality
  • Diagnosis relating to the END framework according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).

You may not qualify if:

  • Absence of signed Informed Consent
  • Control group
  • Female sex
  • Age: 12 to 17 years
  • Italian nationality
  • Absence of signed Informed Consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano IRCCS, Site Piancavallo

Oggebbio, Verbania, 28824, Italy

RECRUITING

MeSH Terms

Conditions

Feeding and Eating DisordersRumination SyndromeAnorexia NervosaBulimia NervosaBinge-Eating Disorder

Interventions

Eating

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Central Study Contacts

Alessandro Sartorio, MD

CONTACT

Luca Grappiolo, Dr.

CONTACT

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

June 26, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations