Active clinical trials for "Feeding and Eating Disorders"

PRO-MENTAL is a non-interventional, prospective, observational study investigating longitudinal associations between diabetes distress, mental disorders, and glycemic outcomes in people with type 1 diabetes (T1D) and type 2 diabetes (T2D). The study aims to determine mental health subtypes, trajectories, and patterns and to advance a precision medicine approach to improve mental health in people with diabetes through personalized care and interventions. A total of 1500 people with T1D or T2D will participate in the study, running over a 24-month period. Participants will be recruited at different levels of diabetes care including specialized centers and hospitals. The assessment includes a baseline assessment (clinical interview, questionnaire survey, and laboratory assessment) and four subsequent measurement time points - every six months - to a total period of two years. Each measurement time point includes an online questionnaire survey as well as a 14-day ambulatory assessment of daily mental and somatic variables (smartphone-based ecological momentary assessment (EMA) of daily sleep quality, mood, stress, and diabetes-related burdens/distress, as well as continuous glucose measurement (CGM) of daily glucose levels). The study uses precision monitoring to identify evidence-based subgroups of people with diabetes with regard to mental disorders/problems and glycemic outcome. Epidemiological data regarding prevalence and incidence rates of depression, anxiety, and eating disorders will be analyzed, and patient trajectories and patterns will be determined. The study also aims to shed more light on the mediating mechanisms between mental health and glycemic outcomes. The findings of the study will be used as the basis to develop a precision medicine approach with personalized interventions for specific sub-groups of people with type 1 and type 2 diabetes.

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.

Aim of this study is to compare fixation of nasoenteral feeding tubes using either a nasal patch or a nasal bridle in clinical patients with regard to the occurrence of tube dislocation, complications, and discomfort. 78 (2 * 39) eligible patients will be included in this randomized controlled trial. The study is executed in two general teaching hospitals in the Netherlands (Gelre Hospitals Apeldoorn and Medical Spectrum Twente).

The goal of this multiple baseline experiment is to test the effect of a digital, gamified early intervention for eating disorders on body image flexibility and determine treatment dose. Twenty-four young women and girls (between the ages of 15-25) with eating disorder (ED) symptoms will be randomized to different baseline durations (varying between 2-6 weeks). Participants will complete eight 20-30 minute sessions of a multimedia application over 10 weeks using their home computer or mobile device. Body Image Flexibility (BIF) will be measured repeatedly using a multimodal assessment strategy (behavior, physiological and self-report) during baseline and treatment phases. The investigators will estimate the effect of the intervention on BIF and examine when change occurs and plateaus (with no discernable benefit for additional sessions) to determine treatment dose.

Prospective data collection using the Neoneur Feeding System to demonstrate device functionality, correlation to historic data, and prepare for a more extensive phase II SBIR trial

Randomized controlled trial of an exposure-based behavioral treatment (CBT) in adults with functional dyspepsia who meet criteria for avoidant/restrictive food intake disorder (ARFID) with weight loss.

Eating disorders (ED) are serious mental illnesses with high mortality rates and significant impact on an individual's quality of life. These disorders are characterized by preoccupation of weight and shape, leading to restrictive eating behavior and compensatory behaviors (purging and excessive/compulsive exercise). Comorbidities with mental health problems are common. Athletes in leanness-focused sports report higher levels of EDs compared to athletes from sports without such focus . Energy Availability (EA) has been suggested the key variable in "Relative Energy Deficiency in Sports" (RED-S) with studies reporting impairment of reproductive function and bone formation. Climbing is a weight sensitive sport where athletes generally, benefit from a lean body shape and low weight, a risk factors for ED. Therefore, climbing athletes can be expected to be at high-risk to develop these conditions. To our knowledge, there are no studies on the prevalence and magnitude of EDs among climbers. Due to the overrepresentation of EDs reported in sports and the poor treatment prognosis, early detection and prevention of ED symptoms are essential. The present study will study the prevalence of ED symptoms, changes over time and trajectories of key variables along with related problem areas such as bone health and mental health problems in order to take steps towards tailored strategies for the prevention of EDs in climbing. The overall purpose of the project is to study prevalence and changes over a two-year period (with a planned follow-up period of up to five years) of eating disordered (ED) symptoms, mental health problems, overuse injuries, bone health as well as indications of relative energy deficiency (RED-S) in elite vs. sub-elite Swedish climbers. Climbers will be compared to a group of normal controls. Further, differences will be studied in groups with high vs. low levels of EDs, comparing occurrence of mental health problems, overuse injuries and bone health. Trajectories of mentioned variables over time will be analyzed.

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.

Eating disorders (EDs) are severe chronic psychiatric disorders with a not fully understood etiopathogenesis. Previous studies have revealed some biological mechanisms of EDs. However, the etiology and maintenance mechanism of EDs, especially the neuro-mechanisms is still unknown. To explore the pathogenic mechanism and treatment biomarkers of EDs, we design this study. the multidimensional data including the clinicopathological features, neuroimaging data (functional and structural magnetic resonance imaging), electroencephalogram and inflammatory cytokines will be used to investigate the biomarkers for diagnosis and treatment effectiveness.

This research project aims to characterize a naturalistic cohort of children and adolescents with eating disorders in terms of biological, psychological and psychopathological features. Further, the project will examine the effectiveness of treatment, the determinants of treatment outcome and the course of treatment response for children and adolescents with eating disorders (ED), treated in a generic specialist child and adolescent mental health service. The first choice of treatment is outpatient family-based treatment (FBT), which has documented effect for anorexia nervosa and bulimia nervosa. However, a subgroup of young persons with eating disorders does not respond sufficiently to this treatment, and evidence concerning effective treatment for children and adolescents with atypical eating disorders is still lacking. Further, treatment effectiveness for children and adolescents in a Danish naturalistic setting has never been examined.