Obesity Clinical Trial
— PREC-BEDOfficial title:
Precursors of Binge Eating Disorder in a Clinical Sample of Adolescents With Obesity: Early MRI Markers of Brain Reward and Inhibition Processing Dysfunction
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 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Sant Joan de Déu | Esplugues De Llobregat | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Fundació Sant Joan de Déu | Instituto de Salud Carlos III |
Spain,
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* Note: There are 72 references in all — Click here to view all references
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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