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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06387719
Other study ID # PREC-BED Study
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 21, 2023
Est. completion date May 2026

Study information

Verified date April 2024
Source Fundació Sant Joan de Déu
Contact Esther Via, PhD
Phone +34 673342094
Email evia@hsjdbcn.es
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

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, InnovaciĆ³n y Universades) and the private company Torrons Vicens.


Recruitment information / eligibility

Status Recruiting
Enrollment 102
Est. completion date May 2026
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 12 Years to 16 Years
Eligibility Inclusion Criteria: - 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. Additional inclusion criteria for the BED and PREC-BED groups: - 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. Exclusion Criteria: - 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.

Study Design


Intervention

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.

Locations

Country Name City State
Spain Hospital Sant Joan de Déu Esplugues De Llobregat Barcelona

Sponsors (2)

Lead Sponsor Collaborator
Fundació Sant Joan de Déu Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

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* Note: There are 72 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Neuroimaging assessment Connectivity analyses using Effective-connectivity (EC) in whole-brain models Baseline (transversal design)
Primary Neuroimaging assessment Brain response during task-based fMRI (Monetary incentive Delay Task, Stop Signal task) Baseline (transversal design)
Secondary Height Height in centimeters Baseline and 1-year follow-up (for the HG and PREC-BED groups).
Secondary Weight Weight in kilograms Baseline and 1-year follow-up (for the HG and PREC-BED groups).
Secondary Waist perimeter Waist perimeter in centimeters Baseline and 1-year follow-up (for the HG and PREC-BED groups).
Secondary BMI Weight and height will be combined to report BMI in kg/m^2 Baseline and 1-year follow-up (for the HG and PREC-BED groups).
Secondary Blood pressure Blood pressure in mm Hg Baseline and 1-year follow-up (for the HG and PREC-BED groups).
Secondary Fasting glucose Fasting glucose in mg/dl Baseline and 1-year follow-up (for the HG and PREC-BED groups).
Secondary Triglycerides Triglycerides in mg/dl Baseline and 1-year follow-up (for the HG and PREC-BED groups).
Secondary HDL cholesterol HDL cholesterol in mg/dl Baseline and 1-year follow-up (for the HG and PREC-BED groups).
Secondary Developmental Tanner stage The scale defines physical measurements of development based on external primary and secondary sex characteristics. Baseline and 1-year follow-up (for the HG and PREC-BED groups).
Secondary 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.
Baseline and 1-year follow-up (for the HG and PREC-BED groups).
Secondary 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). Baseline and 1-year follow-up (for the HG and PREC-BED groups)
Secondary Functioning Global Assessment of Functioning (GAF) Scale (clinician). Units on a scale: 11 to 100, higher scores will indicate a better outcome. Baseline and 1-year follow-up (for the HG and PREC-BED groups)
Secondary 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
Baseline and 1-year follow-up (for the HG and PREC-BED groups)
Secondary 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. Baseline and 1-year follow-up (for the HG and PREC-BED groups).
Secondary 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. Baseline and 1-year follow-up (for the HG and PREC-BED groups)
Secondary 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. Baseline and 1-year follow-up (for the HG and PREC-BED groups)
Secondary 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 Baseline and 1-year follow-up (for the HG and PREC-BED groups)
Secondary 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. Baseline and 1-year follow-up (for the HG and PREC-BED groups)
Secondary 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). Baseline and 1-year follow-up (for the HG and PREC-BED groups)
Secondary 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). Baseline and 1-year follow-up (for the HG and PREC-BED groups)
Secondary General Intelligence Kaufman Brief Intelligence Test (K-BIT): Standard scores have a mean of 100 and a standard deviation of 15 Baseline
Secondary Attention ability Continuous Performance Test (CPT-IP). T-score: The values of the scores depend on the variables. Baseline
Secondary Visuo-constructional ability and visual memory Rey-Osterrieth complex figures task. Standardized scores: higher scores mean a better outcome. Baseline
Secondary Executive function: cognitive flexibility, alternating attention, sequencing, visual search, and motor speed. Trail Making Test (TMT). Standardized scores: higher scores mean a better outcome. Baseline.
Secondary 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.
Baseline.
Secondary Executive function: decision-making abilities reward based Iowa gambling task Standardized scores: higher scores mean a better outcome. Baseline.
Secondary Executive function: ability to inhibit cognitive interference Stroop Test. Standardized scores: higher scores mean a better outcome. Baseline.
Secondary Executive function: planning and strategic organisation Rey-Osterrieth complex figures task. Standardized scores: higher scores mean a better outcome. Baseline.
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