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Feeding and Eating Disorders clinical trials

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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: 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.

NCT ID: NCT05693896 Not yet recruiting - Obesity Clinical Trials

Treating Binge Eating and Obesity Digitally in Black Women

Start date: January 2025
Phase: N/A
Study type: Interventional

More than 30% of Black women with obesity binge eat. Binge eating may increase the risk for the development of metabolic syndrome and binge-eating-disorder (BED), which is associated with severe obesity. Though several effective treatments for binge eating exist, Black women have not fared well. Not only has their inclusion in treatment trials been limited, but when participating, they are more likely to drop out, and/or lose less weight, compared to their White counterparts. Furthermore, treatment for binge eating is often not available in primary care and community-based settings places where Black women are more likely to receive treatment for their eating and weight-related concerns. Currently, there is scant intervention research to treat binge eating in Black women. With the highest rates of obesity (57%) nationally, Black women are in need of culturally-relevant treatments for binge eating and weight gain prevention. Given the established relationship between frequent binge eating and subsequent weight gain, addressing binge eating among Black women with obesity is imperative.

NCT ID: NCT05249140 Not yet recruiting - Clinical trials for Anorexia in Adolescence

Finding Treatments for Eating Disorders

FED
Start date: December 31, 2022
Phase: N/A
Study type: Interventional

Currently, Family Based Treatment (FBT) is the leading evidence-based, manualized treatment for adolescents with anorexia nervosa (AN). FBT emphasizes parental involvement in addressing disordered eating by supporting the child in eating and refeeding to achieve a healthy body weight and independent eating. Based on multiple RCTs, 50% of AN patients who receive FBT recover, and those who do not are more likely to develop a chronic illness. Research demonstrates that weight gain of less than 2.3kg (4.8 pounds) by week 4 of FBT predicts that 75% of adolescents with AN will not achieve weight restoration by the end of treatment. FBT works in part by reducing the avoidance of food and increasing the exposure to food triggers, like the treatment of anxiety disorders and obsessive-compulsive disorder (OCD). Thus, researchers postulate that anxiety may be a negative predictor of FBT treatment outcome in the early phase of FBT. In addition, elevated baseline anxiety has been shown to be associated with poorer outcomes at end of treatment and may also impact the likelihood of early response. To improve clinical response, we need to develop viable biological treatment targets (i.e., brain areas implicated in anxiety) that could be combined with FBT. Such targets can be defined by 1) initially targeting brain areas that mediate symptoms hindering treatment response (i.e., anxiety), and 2) looking at changes in brain chemistry and function. Thus, repetitive transcranial magnetic stimulation (rTMS) could be an alternative and promising treatment approach for adolescents with AN who do not respond to Phase 1 of FBT. Using rTMS, we can target the brain areas implicated in anxiety in people with anorexia and modulate that activity to reduce symptoms, and thus, facilitate response to FBT. Several studies have shown the rTMS to the right dorsolateral prefrontal cortex (DLPFC) is effective in reducing anxiety across a range of neuropsychiatric disorders. Therefore, it is possible that stimulating the right DLPFC could facilitate treatment efficacy of FBT in youth with AN. Additional explorations of the connections between, and neurochemistry of, the right DLPFC and those mediating emotion in the brain (e.g., amygdala) could aid in our understanding of the networks impeding effective treatment responses and allow for more tailored, precision targeting with TMS.

NCT ID: NCT05233046 Not yet recruiting - Mental Health Issue Clinical Trials

Impact of Mindfulness Program on Perceived Wellness, Eating Habits and Relationship to Food

Start date: February 2, 2022
Phase: N/A
Study type: Interventional

Mindfulness, seemingly a simple concept, research shows that the impact of mindfulness on the overall wellness of an individual can be helpful (5). Research supports that mindfulness leads to reduced stress, enhanced performance, better focus, and improved approach (7). Areas of mindfulnessare mindful eating,movement and meditation. Application of mindfulness tools in these areas can be beneficial to health outcomes and to create a happier more efficient work environment (9). Mindful eating shows to improve diet quality and attitudes toward food and eating. Individuals better understand physical hunger/fullness cues, improve nutrient density, weight control,digestion,systolic blood pressure, and stress(2). Disordered eating behaviors have also shown to improve(3). Mindless eating, such as eating while being on the phone, driving, or watching television can have the opposite effect and can be linked to more emotional hunger cues. Combining mindful eating with diet therapy can lead to healthier food choices and a more positive feeling towards eating and body image, reducing stress and improving the overall wellness of an individual (4). Aspire's experience shows that aspects of teacher's wellness is worsening with ,media reporting more and more employees resigning from their positions every day (wccb,2021). Teachers have voiced their need for more support with their wellbeing. As a result, Aspire Nutrition is targeting school employees through a newly developed mindfulness program titled Nourish Carolina. This program will be focused on improving the overall wellness of participants Participants are enrolled in the study for 12 weeks. All participants will have weekly nutritional counseling and bi-weekly mental health counseling. Study group will have nutrition and mental health counseling with mindfulness activities and control group will receive nutrition and mental health sessions without mindfulness activities. There is a program curriculum so that mental health and nutrition mindfulness activities compliment eachother The mindfulness lessons for study group are divided into 6 nutrition and 6 mental health sessions,for 15 minutes during the session. Positive outcomes could include improved workplace performance as a result of enhancing school employees overall wellness and quality of life by reducing stress levels, improving diet quality, and improving mental health.