Precursors of Binge Eating Disorder in a Clinical Sample of Adolescents With Obesity
NCT06387719, Unknown, Fundació Sant Joan de Déu
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Precursors of Binge Eating Disorder in a Clinical Sample of Adolescents With Obesity | ClinicalTrials.gov |
| NCT number | NCT06387719 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Enrollment | 102 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Fundació Sant Joan de Déu | ClinicalTrials.gov |
| Conditions | Binge-Eating Disorder, Obesity, Eating Disorders, BED, Other Specified Feeding or Eating Disorder, Eating Disorder Nos, Emotion Regulation, Food Addiction | ClinicalTrials.gov |
| Interventions | Magnetic resonance imaging | ClinicalTrials.gov |
| First posted | 2024-04-29 | ClinicalTrials.gov |
| Last updated | 2024-04-29 | ClinicalTrials.gov |
Registered outcomes 30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Neuroimaging assessment | Baseline (transversal design) | Connectivity analyses using Effective-connectivity (EC) in whole-brain models | ClinicalTrials.gov |
| Primary | Neuroimaging assessment | Baseline (transversal design) | Brain response during task-based fMRI (Monetary incentive Delay Task, Stop Signal task) | ClinicalTrials.gov |
| Secondary | Height | Baseline and 1-year follow-up (for the HG and PREC-BED groups). | Height in centimeters | ClinicalTrials.gov |
| Secondary | Weight | Baseline and 1-year follow-up (for the HG and PREC-BED groups). | Weight in kilograms | ClinicalTrials.gov |
| Secondary | Waist perimeter | Baseline and 1-year follow-up (for the HG and PREC-BED groups). | Waist perimeter in centimeters | ClinicalTrials.gov |
| Secondary | BMI | Baseline and 1-year follow-up (for the HG and PREC-BED groups). | Weight and height will be combined to report BMI in kg/m\^2 | ClinicalTrials.gov |
| Secondary | Blood pressure | Baseline and 1-year follow-up (for the HG and PREC-BED groups). | Blood pressure in mm Hg | ClinicalTrials.gov |
| Secondary | Fasting glucose | Baseline and 1-year follow-up (for the HG and PREC-BED groups). | Fasting glucose in mg/dl | ClinicalTrials.gov |
| Secondary | Triglycerides | Baseline and 1-year follow-up (for the HG and PREC-BED groups). | Triglycerides in mg/dl | ClinicalTrials.gov |
| Secondary | HDL cholesterol | Baseline and 1-year follow-up (for the HG and PREC-BED groups). | HDL cholesterol in mg/dl | ClinicalTrials.gov |
| Secondary | Developmental Tanner stage | Baseline and 1-year follow-up (for the HG and PREC-BED groups). | The scale defines physical measurements of development based on external primary and secondary sex characteristics. | ClinicalTrials.gov |
| Secondary | Adherence to Mediterranean diet | Baseline and 1-year follow-up (for the HG and PREC-BED groups). | Self-administered questionnaire (The Kid-MED). Units on a Scale: Total score from 0 to 12. Score ≥8: Optimal dietary quality. Score 4-7: Intermediate dietary quality. Improvements are needed to enhance adherence to the MedDiet. Score ≤3: Very low dietary quality. | ClinicalTrials.gov |
| Secondary | Diagnosis of BED, and PREC-BED or exclusion of other DMS-5 diagnosis. | Baseline and 1-year follow-up (for the HG and PREC-BED groups) | The Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS-PL): semi-structured interview to parents or legal guardians and subjects aimed to diagnosis mental disorders based on DMS-5 criteria, administered by health care providers (clinician). | ClinicalTrials.gov |
| Secondary | Functioning | Baseline and 1-year follow-up (for the HG and PREC-BED groups) | Global Assessment of Functioning (GAF) Scale (clinician). Units on a scale: 11 to 100, higher scores will indicate a better outcome. | ClinicalTrials.gov |
| Secondary | Depression | Baseline and 1-year follow-up (for the HG and PREC-BED groups) | Beck Depression Inventory for Children (BYI-2): Spanish adapted self-administered questionnaire for depressive symptoms (child) T-scores: * ≥70 Very high * 60-69 Quite high * 55-59 Somewhat high * \<55 Average | ClinicalTrials.gov |
| Secondary | Anxiety | Baseline and 1-year follow-up (for the HG and PREC-BED groups). | The Screen for Child Anxiety Related Disorders (SCARED). A total score of 25 may indicate the presence of an anxiety disorder. Scores higher than 30 are more specific. | ClinicalTrials.gov |
| Secondary | Emotion Regulation | Baseline and 1-year follow-up (for the HG and PREC-BED groups) | Difficulties Emotion Regulation Scale (DERS): Subscales and total scores are obtained by the sum of the corresponding items and higher scores indicate more difficulties in Emotional Regulation. | ClinicalTrials.gov |
| Secondary | Eating symptomatology | Baseline and 1-year follow-up (for the HG and PREC-BED groups) | Eating Disorder Examination Questionnaire-Adolescents (EDE-Q-A): It generates three scales a) the Restraint subscale, b) the Weight, Figure and Eating Concern subscale, and c) the Total scale. Higher scores mean a worse outcome. | ClinicalTrials.gov |
| Secondary | Eating symptomatology | Baseline and 1-year follow-up (for the HG and PREC-BED groups) | \- Emotional Eating Scale Adapted for Children and Adolescents (EES-C): It generates subscales (anger, anxiety, depression, restlessness and hopelessness). higher scores mean a worse outcome | ClinicalTrials.gov |
| Secondary | Temperamental tendencies for sensitivity to punishment and sensitivity to reward. | Baseline and 1-year follow-up (for the HG and PREC-BED groups) | The Sensitivity to Punishment and Sensitivity to Reward Questionnaire Junior (SPSRQ-J). It generates two subscales sensitivity to punishment and sensitivity to reward. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 60
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 938196 | BACKGROUND | PubMed |
| 7866415 | BACKGROUND | PubMed |
| 8039375 | BACKGROUND | PubMed |
| 8640205 | BACKGROUND | PubMed |
| 9100430 | BACKGROUND | PubMed |
| 9204677 | BACKGROUND | PubMed |
| 12629570 | BACKGROUND | PubMed |
| 12900986 | BACKGROUND | PubMed |
| 15732070 | BACKGROUND | PubMed |
| 16367401 | BACKGROUND | PubMed |
| 16567152 | BACKGROUND | PubMed |
| 16958120 | BACKGROUND | PubMed |
| 17262813 | BACKGROUND | PubMed |
| 18549996 | BACKGROUND | PubMed |
| 18560701 | BACKGROUND | PubMed |
| 19834472 | BACKGROUND | PubMed |
| 20376329 | BACKGROUND | PubMed |
| 21114355 | BACKGROUND | PubMed |
| 21534053 | BACKGROUND | PubMed |
| 22326512 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 9
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Monetary Incentive Delay | Primary outcome | ConductCognition |
| Stop-Signal Task | Primary outcome | ConductCognition |
| Complex Figure Copy and Recall | Secondary outcome | ConductCognition |
| Continuous Performance Test | Secondary outcome | ConductCognition |
| Iowa Gambling Lite | Secondary outcome | ConductCognition |
| Letter-Number Sequencing Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)