An observational study in Binge-Eating Disorder, Obesity and Eating Disorders, sponsored by Fundació Sant Joan de Déu. Recruiting at 1 site in Spain. Open to participants aged 12 Years to 16 Years. Per ClinicalTrials.gov, last updated 2024-04-29.
Sponsored by Fundació Sant Joan de Déu · Observational
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.
Background
Binge eating disorder (BED) has been a diagnosis on its own only since the last edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) in 2013. It is the most prevalent eating disorder worldwide, affecting more than 50 million subjects, world-wide. BED is characterized by binge eating episodes: eating a large amount of food in a discrete period and with a sense of lack of control. Two main peaks of onset have been identified: one is at mean age 14 and the second between 18-20 years old. BED is one of the primary chronic illnesses among adolescents and is commonly associated with psychiatric comorbidities (more than 60% of lifetime prevalence), but also with obesity and its physical consequences, showing a high impact in life functioning and a high morbi-mortality. BED prevalence in youth populations is between 1-3%, and up to 37% in adolescent population with obesity. These figures have raised in parallel with the high increase in obesity prevalence in this population. When considering subclinical presentations in the general population, which involve presenting some symptoms but not fulfilling all the diagnostic criteria for BED, the prevalence is 3%. Subclinical forms are described with terms such as emotional eating, disorganized eating, loss of control eating, among others. The latter is the only construct that has operationalized criteria. In some cases, but not all, individuals with these conditions might be diagnosed with specified or unspecified DSM-5 eating disorder categories ("other specified feeding or eating disorder" -OSFED-, or "eating disorder not otherwise specified" -EDNOS-).
The first symptoms of BED often appear in youths, who frequently exhibit incomplete criteria, which are associated with a future development of BED (i.e. subclinical forms or precursor forms, PREC-BED). These subclinical forms are more frequent in adolescents, in comparison to adults. The factors determining the conversion from PREC-BED to BED are unknown and to our knowledge, only one study evaluated the percentage of conversion to BED in a small sample of adolescents with PREC-BED, finding a 28% conversion rate. There is no gold standard for identifying the clinical progression of incomplete forms, which hinders prevention and personalized treatment.
The most kown underlying factor identified in BED is a dysfunction in emotional regulation, and neuroimaging studies have identified alterations in relevant brain circuits involved in these functions, such as reward response and response inhibition. These alterations are observed in BED and seem to be present in PREC-BED and could potentially predict a greater vulnerability or resilience to developing BED in the future. For example: Reward response: Subjects with BED present increased preference for immediate reward (as opposed to delayed), greater food-reward sensitivity and greater rash-spontaneous behaviour in the context of food. At the brain level, despite the scarce evidence, a large longitudinal study (i.e. Adolescent Brain Cognitive Development -ABCD- study) suggests that early brain structural differences during childhood of key reward regions (i.e. nucleus accumbens) might be a genetic predisposition for the development of obesity and possibly of an altered pattern of eating. In adult samples of BED, a few studies found structural or functional alterations in regions of the reward system. Inhibition: Evidences of poor impulse control or decreased inhibitory control come from adult samples, but also from the limited samples in youth, which are also limited. In adolescents with PREC-BED, some studies found hypoactivations during inhibitory processing regions, or during the inhibition of emotions in the the context of negative mood induction through a peer interaction paradigm. In another study, hyperactivations (as opposite to hypoactivations) of self-regulatory regions when receiving milkshake flavours during the neuroimaging session, were suggested as compensatory early mechanisms, representing an increased cognitive effort to regulate emotions under such restrictive conditions. Studies in BED were only found in adults.
Neuroimaging techniques using magnetic resonance imaging (MRI) allow for non-invasive study of live brain activity, which can be done during the participation of the subject in a task (for example, an inhibition task or a response processing task). This would allow the visualization of functional deficits evidenced during a cognitive demand; in the same manner the cardiologist may realize exercise tolerance test. Advanced MRI techniques nowadays offer unique insights into the anatomical and functional architecture of the brain. For example, advanced MRI brain connectivity (MRI-BC) techniques incorporate the modelling of brain dynamics between regions, which approximates to the inherent complexity of brain architecture and psychiatric disorders and open new perspective to investigate circuits and alterations involved in neurological and diseases. Such analysis can be conducted during a resting state in the MRI session, but also during specific task (for example, inhibition response task or reward-based task). One of the available whole-brain models of MRI-BC is called effective connectivity (EC), which provides information of the hierarchical or directional connectivity and/or activation between brain regions and networks. Our team (UPF team members) has developed a new technique to estimate EC, the MOU-EC generative model (Multivariate Ornstein-Uhlenbeck), which improves interpretability over other techniques and has been shown its relevance in predicting outcomes. Similar advanced techniques have proven useful in a few studies in eating disorders, including children with BED in one study and in EC in taste and food intake regulating circuits in anorexia and bulimia nervosa.
The development of prognostic markers in PREC-BED forms in the child and adolescent population would be highly relevant to increase the detection of these forms, prevent the development of BED, and enable early and personalized treatment. While neuroimaging markers alone and for diagnostic purposes have not yielded the expected results in other pathologies, it is possible that MRI-BC alone or in combination with other clinical and neuropsychological variables could constitute more sensitive and specific predictive models of risk, especially in pathologies with a bio-psychosocial origin like BED.
PROJECT'S AIM
The aim is to characterize regulation (reward and inhibition-based) processes in PREC-BED and BED in adolescents and to explore MRI-BC neurobiological markers of PREC-BED diagnosis and of prognosis at 1 year of follow-up.
FUNDING
Grant by the Instituto de Salud Carlos III (Ministerio de Ciencia, Innovación y Universades) and the private company Torrons Vicens.
233 studies on the registry are indexed under Binge-Eating Disorder; 53 are open to participants now.
This study's planned enrollment of 102 is below the median of 118 across 35 observational studies indexed under Binge-Eating Disorder.
Browse Binge-Eating Disorder studies →Fundació Sant Joan de Déu is the lead sponsor of 70 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Additional inclusion criteria for the BED and PREC-BED groups:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
adolescents with obesity, measured as BMI z-score above 2 standard deviations, and BED
Diagnostic Test: Magnetic resonance imaging
adolescents with obesity, measured as BMI z-score above 2 standard deviations, PREC-BED
Diagnostic Test: Magnetic resonance imaging
* 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
Neuroimaging assessment
Connectivity analyses using Effective-connectivity (EC) in whole-brain models
Time frame: Baseline (transversal design)
Neuroimaging assessment
Brain response during task-based fMRI (Monetary incentive Delay Task, Stop Signal task)
Time frame: Baseline (transversal design)
Height
Height in centimeters
Time frame: Baseline and 1-year follow-up (for the HG and PREC-BED groups).
Weight
Weight in kilograms
Time frame: Baseline and 1-year follow-up (for the HG and PREC-BED groups).
Waist perimeter
Waist perimeter in centimeters
Time frame: Baseline and 1-year follow-up (for the HG and PREC-BED groups).
BMI
Weight and height will be combined to report BMI in kg/m\^2
Time frame: Baseline and 1-year follow-up (for the HG and PREC-BED groups).
Blood pressure
Blood pressure in mm Hg
Time frame: Baseline and 1-year follow-up (for the HG and PREC-BED groups).
Fasting glucose
Fasting glucose in mg/dl
Time frame: Baseline and 1-year follow-up (for the HG and PREC-BED groups).
Triglycerides
Triglycerides in mg/dl
Time frame: Baseline and 1-year follow-up (for the HG and PREC-BED groups).
HDL cholesterol
HDL cholesterol in mg/dl
Time frame: Baseline and 1-year follow-up (for the HG and PREC-BED groups).
Developmental Tanner stage
The scale defines physical measurements of development based on external primary and secondary sex characteristics.
Time frame: Baseline and 1-year follow-up (for the HG and PREC-BED groups).
Adherence to Mediterranean diet
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.
Time frame: Baseline and 1-year follow-up (for the HG and PREC-BED groups).
Diagnosis of BED, and PREC-BED or exclusion of other DMS-5 diagnosis.
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).
Time frame: Baseline and 1-year follow-up (for the HG and PREC-BED groups)
Functioning
Global Assessment of Functioning (GAF) Scale (clinician). Units on a scale: 11 to 100, higher scores will indicate a better outcome.
Time frame: Baseline and 1-year follow-up (for the HG and PREC-BED groups)
Depression
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
Time frame: Baseline and 1-year follow-up (for the HG and PREC-BED groups)
Anxiety
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.
Time frame: Baseline and 1-year follow-up (for the HG and PREC-BED groups).
Emotion Regulation
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.
Time frame: Baseline and 1-year follow-up (for the HG and PREC-BED groups)
Eating symptomatology
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.
Time frame: Baseline and 1-year follow-up (for the HG and PREC-BED groups)
Eating symptomatology
- 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
Time frame: Baseline and 1-year follow-up (for the HG and PREC-BED groups)
Temperamental tendencies for sensitivity to punishment and sensitivity to reward.
The Sensitivity to Punishment and Sensitivity to Reward Questionnaire Junior (SPSRQ-J). It generates two subscales sensitivity to punishment and sensitivity to reward.
Time frame: Baseline and 1-year follow-up (for the HG and PREC-BED groups)
Food Addiction
Yale Food Addiction Scale for Children (YFAS-C): The scores provide an assessment of food addiction in two different ways. On one hand, the "symptom count," which offers a scoring version reflecting the number of dependency symptoms based on the 7 described criteria without considering clinical importance in the scoring (minimum 0, maximum 7 points). And, on the other hand, the "addiction diagnosis," which evaluates whether the diagnosis of food addiction can be established or not, and is confirmed when there are three or more symptoms present and significant clinical distress or impairment (questions 15 and 16).
Time frame: Baseline and 1-year follow-up (for the HG and PREC-BED groups)
Food intake
Questionnaire on frequency of dietary intake (CFCA): The NOVA classification will be used to extract information of the intake of ultra-processed foods and drinks for each subject (daily grams of UPFD intake/total daily grams, multiplied by 100) for each participant (world.openfoodfacts.org).
Time frame: Baseline and 1-year follow-up (for the HG and PREC-BED groups)
General Intelligence
Kaufman Brief Intelligence Test (K-BIT): Standard scores have a mean of 100 and a standard deviation of 15
Time frame: Baseline
Attention ability
Continuous Performance Test (CPT-IP). T-score: The values of the scores depend on the variables.
Time frame: Baseline
Visuo-constructional ability and visual memory
Rey-Osterrieth complex figures task. Standardized scores: higher scores mean a better outcome.
Time frame: Baseline
Executive function: cognitive flexibility, alternating attention, sequencing, visual search, and motor speed.
Trail Making Test (TMT). Standardized scores: higher scores mean a better outcome.
Time frame: Baseline.
Executive function: working memory ability
Letter-number sequencing (subtest of the Wechsler Intelligence Scale for Children-Fifth Edition - WISC-V). Standardized scores: higher scores mean a better outcome.
Time frame: Baseline.
Executive function: decision-making abilities reward based
Iowa gambling task Standardized scores: higher scores mean a better outcome.
Time frame: Baseline.
Executive function: ability to inhibit cognitive interference
Stroop Test. Standardized scores: higher scores mean a better outcome.
Time frame: Baseline.
Executive function: planning and strategic organisation
Rey-Osterrieth complex figures task. Standardized scores: higher scores mean a better outcome.
Time frame: Baseline.
Plan to share: Yes — All of the individual deidentified participant data may be provided to qualified researchers with academic interest in eating disorders. Data shared will be pseudonymised, with no Protected Health Information (PHI included).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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.
Started Jul 2023 (actual). Primary completion is estimated for Mar 2025, 20 months after the start.
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Fundació Sant Joan de Déu