Precursors of Binge Eating Disorder in a Clinical Sample of Adolescents With Obesity

NCT06387719 | Recruiting

• 1 other identifier: PREC-BED Study
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND: Binge eating disorder (BED) is the worldwide most-prevalent eating disorder. It is associated with psychiatric comorbidities and obesity, a high impact in life functioning, and high morbidity and mortality. First symptoms appear frequently in youths, who most commonly present incomplete (subthreshold) criteria for BED (precursor forms, PREC-BED). While some subjects will evolve from PREC-BED to BED, there is no gold standard to identify the clinical evolution. Information from prior studies suggest early alterations in reward and inhibitory brain circuits in PREC-BED may predict increased vulnerability or resilience to develop BED. Tools based on MRI brain connectivity analyses (MRI-BC), built on robust and interpretable connectivity whole-brain models, have proven successful in diagnostic classification and predicting certain clinical outcomes. OBJECTIVES: To study MRI-BC diagnostic markers of PREC-BED and to explore prognosis at 1 year of follow-up in a sample of adolescents with obesity (12-17 years old). METHODS: A) Transversal analytical design: 3-group (n=34 per group) comparison of neuroimaging (MRI-BC), neurocognitive and clinical markers in adolescents with obesity and i) BED, ii) PREC-BED, iii) no BED nor PREC-BED (Healthy group, HC). B) Longitudinal analytical design, pilot, exploratory: adolescents with PREC-BED will be evaluated in clinical and neurocognitive variables at 1 year. Baseline brain neuroimaging variables (alone and in combination with clinical and neurocognitive variables) will be analyzed as predictors of clinical prognosis, including conversion to BED.

Conditions

Binge-Eating Disorder; Obesity; Eating Disorders; BED; Other Specified Feeding or Eating Disorder; Eating Disorder Nos; Emotion Regulation; Food Addiction

Keywords

Binge Eating Disorder; Mental Health; Adolescents; Loss of control; Emotional eating; BED; youths; neuroimaging; reward response; response inhibition; magnetic resonance

Outcome Measures

Primary Outcomes (2)

• Neuroimaging assessment

  Connectivity analyses using Effective-connectivity (EC) in whole-brain models

  Baseline (transversal design)

• Neuroimaging assessment

  Brain response during task-based fMRI (Monetary incentive Delay Task, Stop Signal task)

  Baseline (transversal design)

Secondary Outcomes (28)

• Height

  Baseline and 1-year follow-up (for the HG and PREC-BED groups).

• Weight

  Baseline and 1-year follow-up (for the HG and PREC-BED groups).

• Waist perimeter

  Baseline and 1-year follow-up (for the HG and PREC-BED groups).

• BMI

  Baseline and 1-year follow-up (for the HG and PREC-BED groups).

• Blood pressure

  Baseline and 1-year follow-up (for the HG and PREC-BED groups).

Study Arms (3)

Control group (CG)

Adolescents with obesity, measured as body mass index (BMI) z-score above 2 standard deviations, and no BED/PREC-BED

Diagnostic Test: Magnetic resonance imaging

BED group

adolescents with obesity, measured as BMI z-score above 2 standard deviations, and BED

Diagnostic Test: Magnetic resonance imaging

PREC-BED group

adolescents with obesity, measured as BMI z-score above 2 standard deviations, PREC-BED

Diagnostic Test: Magnetic resonance imaging

Interventions

Magnetic resonance imaging DIAGNOSTIC_TEST

* Basic sequence for ethical consideration: evaluation of casual findings. * Structural MRI. * Functional MRI (fMRI) in the Resting-state * fMRI- task based. Presented in a computer screen on a magnetically compatible googles.

Also known as: Clinical assessment, Neurocognitive assessment

BED group; Control group (CG); PREC-BED group

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents with obesity (12-16 y/o) would be consecutively asked to participate when attending their visits at the Endocrinology Department at Hospital Sant Joan de Déu (HSJD).

You may qualify if:

• Patients derived to the Endocrinology Department with obesity as the main criterion for consultation, measured as body mass index (BMI) z-score above 2 standard deviations.
• Age between 12-16 years old.
• Signed informed consent by parents or legal guardians of subjects, plus the signed consent by the adolescent when being 12 or older years/old.
• The presence of DSM-5 criteria for BED in the BED group.
• Fulfilling the LOC (loss of control) criteria (related to the original Marcus\&Kalarchian) in the PREC-BED group.

You may not qualify if:

• Intelligence quotient \< 70 measured with the K-BIT.
• Any comorbid psychiatric disorder, except BED in the BED group or PREC-BED in the PREC-BED group. Tobacco use and the presence of an adaptative disorder or any mild anxiety disorder will be accepted in all groups.
• Traumatic brain injury or any neurological disorder.
• Use of dental braces (due to important artifact in MRI).
• MRI: Absolute contraindications (e.g.: metal objects), relative contraindications (claustrophobia). Anthropometric measures: Weight \> 150Kg or shoulder to shoulder measurement \> 70 cm.
• Any severe medical conditions (including Sleep apnea-hypopnea syndrome), except for obesity and metabolic syndrome.
• Not signing the informed consent.
• Pregnancy for females.

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona, 08950, Spain

RECRUITING

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Related Links

• Organization WH. Obesidad y sobrepeso. Published 2023. Accessed April 23, 2023.
• ABCD Research Consortium. ABCD Study. Published 2015. Accessed March 20, 2022.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Neuroimaging

MeSH Terms

Conditions

Binge-Eating Disorder; Obesity; Feeding and Eating Disorders; Emotional Regulation; Food Addiction; Psychological Well-Being; Emotional Eating

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Self-Control; Social Behavior; Behavior; Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Personal Satisfaction; Feeding Behavior

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Esther Via, PhD

  Hospital Sant Joan de Deu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esther Via, PhD

CONTACT

+34 673342094; evia@hsjdbcn.es

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: April 29, 2024
• Study Start: July 21, 2023
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2026
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Proposals should be directed to the principal investigator. To gain access, data requestors will need to sign a data agreement with our institution, to comply with legal requirements and data protection rights. The study protocol and/or an amendment to the protocol will be reviewed by the corresponding Ethics Committees.

Locations

ES (1)