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Feeding and Eating Disorders clinical trials

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NCT ID: NCT06039514 Not yet recruiting - Clinical trials for Eating Disorders in Adolescence

Mobile App for Eating Disorders in Adolescents

Start date: April 9, 2024
Phase: N/A
Study type: Interventional

This study aims to evaluate the effectiveness of GGTCA-AD to decrease the maladaptive beliefs associated with eating disorders (ED) in non-clinical adolescent population. Specifically, a randomized controlled trial with parallel design and two groups (experimental and control) will be carried out in adolescents aged 13-15 years to assess the changes pre and post use of the app. It is expected that after the use of the GGTCA-AD app for 14 days, at the primary level, a: decrease in the degree of ascription to dysfunctional beliefs associated with ED; and at the secondary level: increase in body satisfaction and self-esteem; decrease in eating symptomatology; and no changes in emotional symptomatology. These results are also expected to be maintained in subsequent follow-up at 1 month.

NCT ID: NCT05909787 Not yet recruiting - Eating Disorders Clinical Trials

Prevalence of Oral Disorders in Children in ENT Pathologies

Preora
Start date: July 1, 2023
Phase: N/A
Study type: Interventional

Many children have eating and verbal oral disorders. Our research entitled: PREORA aims to study the prevalence of oral disorders presented in children consulting in ENT department for three months (n = 2000). This first study will be carried out by passing the MCH (Montreal Children's Hospital) feeding scale, a self-questionnaire completed by the parents, in order to assess the presence of disorders according to the parents and will allow us to present oral disorders (Score > 70).

NCT ID: NCT05897398 Not yet recruiting - Obesity Clinical Trials

SEMASEARCH, Retrospective/Prospective Cohort Nested at ATUc/AP2 WEGOVY®

SEMASEARCH
Start date: April 2024
Phase:
Study type: Observational [Patient Registry]

The aim of the SEMASEARCH project is therefore to constitute a retrospective cohort, from the available data on patients already included in the ATUc/AP2, and prospective, on new patients who will initiate treatment according to the AP2 PUT, of 15 Specialized Obesity Centers in order to describe the effect of WEGOVY® treatment in this population. Thanks to a high phenotyping, subpopulations of interest will be identified to know the specifics of the effect of the treatment in these subgroups of interest. Secondary analyses will aim to look for clinical or biological biomarkers of success in the weight response to WEGOVY® in the entire prospective cohort, but also in specific subpopulations. In summary, the analysis of the entire SEMASEARCH cohort and sub-populations of interest will be based on a complete clinical phenotyping of patients (included in retrospective and prospective studies), completed by ad hoc questionnaires and associated with biological markers (prospective) partly collected within the framework of the WEGOVY® AP (glycaemia, hepatic assessment, lipid assessment ) and partly from a biobank to test specific hypotheses (predictive role of leptin sensitivity, insulin sensitivity level, plasma level of endocannabinoids, etc.). In addition, approaches using artificial intelligence (AI), notably machine learning, will make it possible to determine the variables or combination of variables that are most predictive of the weight response to treatment with WEGOVY® in the largest population. Indeed, individual weight loss in response to weight loss strategies is highly variable, whether purely related to lifestyle changes or pharmacological. Well-known factors associated with the ability to lose weight include adherence to lifestyle change, gender, age and specific medications. However, after controlling for these factors, differences in weight loss appear to persist in response to different interventions including pharmacological ones. Adaptation to energy deficit involves complex feedback mechanisms, and inter-individual differences are likely to arise from a range of poorly defined factors. Thus, a better understanding of the factors involved in inter-individual variability in response to WEGOVY® will help guide more personalised approaches to the management of these patients. AI techniques will be used to determine which combination of clinical or biological variables are most predictive of weight response.

NCT ID: NCT05879679 Not yet recruiting - Bulimia Nervosa Clinical Trials

Pilot Study on the Validity of the Metacognitive Hub Model of Craving in Bulimia Nervosa (BN) and Binge Eating Disorders (BED)

MetaBou
Start date: January 8, 2024
Phase:
Study type: Observational

Craving is defined as an irrepressible urge to consume certain products and represents one of the key factors in severe substance use disorders, as illustrated by its recent inclusion as a diagnostic criterion in the most recent fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM 5). However, the pathophysiological models of craving remain debated. The "metacognitive hub model", a conceptual, experimental and clinical approach to craving, proposes that craving should be considered as the embedded consequence of the interaction between three components (the reflexive, automatic and interoceptive systems), each of which has an implicit and explicit element. This model links the three components by suggesting that metacognitive abilities, the ability to understand one's own cognitive functioning, may be a skill of individuals that allows them to make the three sub-components explicit or not. To date, the conception of eating disorders is increasingly similar to that of addictive disorders. Indeed, there is growing evidence that the symptomatology of bulimia nervosa and binge eating disorder can be considered in part as an "food addiction" and would fit the diagnostic criteria of an addictive disorder. Bulimia nervosa is an eating disorder (DSM 5) characterized by a cycle of binge eating and compensatory behaviors such as self-induced vomiting that tend to negate or compensate for the effects of the binge eating. Binge eating disorder (DSM 5) is characterized by a cycle of binge eating, but without the compensatory behaviors seen in bulimia nervosa. In addition, there are common neurological aspects as well as similar cognitions between these eating disorders and addictive disorders. Given the importance of craving in addictive pathology, it seems essential to address this issue in bulimia nervosa and binge eating disorder. The cognitive difficulties of patients with bulimia nervosa and binge eating disorder, which are close to the difficulties observed in patients with addictive behaviors, suggest that the "metacognitive hub model" could provide a clear and measurable theoretical framework of the different dimensions of craving. The overall objective of this project is to explore the relationship between the level of craving induced by food picture exposure and the level of impairment of the reflexive, automatic, interoceptive, and metacognitive systems in women with bulimia nervosa and binge eating disorder and to compare these impairments according to the nature of the eating disorder (i.e., binge eating versus bulimia nervosa). Our hypotheses are: 1. the induction of food craving will affect the reflexive, automatic, and interoceptive systems of patients with bulimia nervosa and binge eating disorder. 2. the magnitude of the effect of food craving induction on implicit craving and explicit craving will be modulated by the participants' metacognitive abilities.

NCT ID: NCT05873127 Not yet recruiting - Clinical trials for Feeding and Eating Disorders

Web-based Guided Self-help CBT-E vs Online G-CBT-E for Binge Eating Behavior

Start date: July 2023
Phase: N/A
Study type: Interventional

Eating disorders with binge eating as the core feature include bulimia nervosa (BN) and binge eating disorder (BED). In recent years, the prevalence rate has increased rapidly, mostly among women, accompanied by emotional problems, physiological complications and increased risks of obesity and depression, which bring great pain to patients. Enhanced Cognitive Behavioral therapy (CBT-E) for eating disorders is an evidence-based and effective first-line psychotherapy for BN and BED. CBT-E is implemented in various forms. In addition to face-to-face therapy, online group CBT-E and guided self-help CBT-E can significantly reduce binge eating in BN and BED patients. However, there are no relevant clinical studies in China. Since 2008, the applicant has carried out CBT treatment and research on eating disorders, translated and published the self-help book "Overcoming Overeating", and accumulated rich clinical research experience. This study intends to establish a set of CBT-E self-help therapy courses suitable for Chinese binge eating patients, and conduct a randomized controlled study of web-based guided self-help CBT-E and online group CBT-E to compare the effectiveness of the treatment modalities in the treatment of binge eating and the feasibility of online guided self-help CBT-E and online group CBT-E in the treatment of binge eating.

NCT ID: NCT05865288 Not yet recruiting - Eating Disorders Clinical Trials

The Moderating Role of Baseline Oxytocin on Its Psychotherapy-facilitating Effects Among Patients With Eating Disorders

Start date: June 30, 2023
Phase: Phase 1
Study type: Interventional

Introduction: Oxytocin (OT) is a nine-amino acid neuropeptide known to play a vital part in social behaviors and has also been found to be involved the social manifestations of mental illnesses, such as social manifestations and social cognition. it has been suggested that OT administration may serve as an add-on treatment for individuals with mental illnesses. One group of patients affected by social are patients with eating disorders (EDs). Studies of OT administration among individuals with EDs have shown an inconsistent pattern of findings, which might be associated with the differential baseline level of OT dysregulation. Thus OT dosing needs to be optimized, while considering patients baseline OT levels prior to administration. Patients with ED are also known to have lower OT levels at baseline. It is possible that OT's administration will affect interpersonal behavior through the increase of lowered OT levels, thus leading to overall improvement of ED symptoms. This study aims to examine the effects of OT administration among patients with EDs, while focusing on baseline OT levels and interpersonal abilities as potential moderators and/or mediators of its effects. The research addresses the following questions: (1) is OT administration associated with increased therapeutic gains among patients with ED? (2) what are the moderators and mediators of these effects, and specifically, do baseline levels of OT and baseline interpersonal abilities moderate these effects? (3) what is the mechanism underlying OT's therapeutic effects, and specifically do changes in interpersonal abilities and changes in OT levels serve a mediating role? Methods: This study aims to assess the differential effect of OT administration among patients with varying levels of baseline saliva OT and to explore the effects of optimizing frequency and dosage of administration of OT, based on baseline characteristics. Participants: Female and male Individuals (N=90) with verified diagnosis of EDs, age 16 and above, will participate in at least four weeks of treatment at the EDs unit. Subjects will be recruited at the Teradion Eating Disorder Clinic, an outpatient unit in North Israel. Procedure: Patients and caregivers will sign an informed consent form. Baseline saliva OT will be measured four times during consecutive days. At week 1 patients will be assessed for general distress, ED symptoms, cognitive rigidity, interpersonal abilities, as well as patients and therapists reported working alliance. At week 2 patients will be randomized at a ratio of 2:1 with 60 patients receiving OT and 30 receiving placebo. Patients will receive 24 IU of OT or placebo, once a week, prior to therapy sessions, for a period of 4 weeks. During these weeks (2-5), they will be assessed for levels of OT, general distress, interpersonal abilities, working alliance and cognitive rigidity. All measurements will be performed finally at week 6. Novelty: This study is the first to assess the effectiveness of OT as an add-on for patients with EDs, during clinical treatment, as well as to explore modulators such as baseline OT levels, and mediators such as social abilities and cognitive rigidity, on the overall improvement of ED patients in therapy.

NCT ID: NCT05837312 Not yet recruiting - Clinical trials for Eating Disorder Symptoms

Testing the Effects of RISE on Eating Pathology

Start date: August 2023
Phase: N/A
Study type: Interventional

Interoception is the process of perceiving one's bodily sensations. Interoception is critical for survival and maintaining homeostasis, as it motivates sensation- and need-specific autonomic reflexes and adaptive behaviors (e.g., eating when hungry, terminating eating upon fullness, drinking when thirsty). Not all individuals have accurate interoceptive abilities. Individuals with eating disorders often have low perception of gastrointestinal, pain, and emotion sensations. Interoceptive dysfunction is believed to influence the development and maintenance of many forms of psychopathology. Identifying effective ways to restore accurate interoceptive processing is an important aim for clinical researchers. The goal of the present study is to continue to test the effectiveness of a training for interoceptive dysfunction that aims to reconnect individuals with eating disorders with their internal sensations, which is called, Reconnecting to Internal Sensations.

NCT ID: NCT05829941 Not yet recruiting - Clinical trials for Binge-Eating Disorder

Technology Assisted Treatment for Binge Eating Behavior

Start date: December 2024
Phase: N/A
Study type: Interventional

Binge-eating behavior is a central feature of eating disorders (e.g., binge-eating disorder, bulimia nervosa, anorexia nervosa-binge-eating/purging subtype) and is associated with higher rates of psychopathology, psychosocial impairment, medical comorbidity, and more severe obesity, all of which pose significant public health problems. Passive detection of binge eating episodes combined with a context-based reminder intervention could assist a patient in resuming healthy eating patterns. This study will test a smartwatch app that identifies binge eating behavior and provides CBT strategies to the patient after the episode.

NCT ID: NCT05806944 Not yet recruiting - Clinical trials for Binge-Eating Disorder

Transcranial Magnetic Stimulation for Binge Eating Disorder

Start date: December 15, 2023
Phase: N/A
Study type: Interventional

The primary goal of this study is to elucidate the impact of disorder provocation on the efficacy of TMS for the treatment of BED. In order to meet this objective, the investigators propose to evaluate this relationship in using a crossover study. Secondary objectives of this study include determining whether TMS with or without BED symptom provocation has effects in altering neurophysiology as detected by fMRI.

NCT ID: NCT05722470 Not yet recruiting - Eating Disorders Clinical Trials

Eating Disorders Among Adolescents

Start date: March 1, 2023
Phase:
Study type: Observational

The aim of the present study is to evaluate the prevalence of eating disorder among adolescents. Also, to evaluate psychiatric comorbidity, sleep problems, alexithymia and emotion dysregulation associated with patients had eating disorders. In addition, to identify possible risk factors associated with eating disorder among adolescents.