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Feeding and Eating Disorders clinical trials

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NCT ID: NCT05105308 Active, not recruiting - Clinical trials for Eating Disorders in Children

Chompions! A Treatment Study for Childhood Avoidant/Restrictive Food Intake Disorder (ARFID)

Start date: February 10, 2022
Phase: N/A
Study type: Interventional

Avoidant Restrictive Food Intake Disorder (ARFID) is a disorder that affects toddlers, children, adolescents, and adults. Individuals with ARFID are not able to consume an adequate amount or variety of food to a degree that it affects their mental and/or physical health. ARFID often begins in early childhood so it is important to treat children in early in life as possible to prevent any negative consequences of poor nutrition. There are currently no treatments for young children with ARFID. The investigators have developed two different study programs and the purpose of this study is to test them out and see if they help children with ARFID and to learn more about how these study programs work.

NCT ID: NCT05035927 Active, not recruiting - Clinical trials for Binge Eating Disorder

Evaluation of Psilocybin (TRP-8802) in the Treatment of Binge Eating Disorder

Start date: March 16, 2022
Phase: Phase 2
Study type: Interventional

To better understand the potential benefits of psychedelics in overeating disorders, Tryp Therapeutics will conduct a safety and feasibility clinical trial using TRP 8802 among individuals with Binge Eating Disorder. This is a single-center phase 2a open-label study to assess the safety and feasibility of a single dose of TRP 8802 in subjects with BED. Subjects will undergo screening, preparation therapy sessions, dosing, integration therapy sessions, and follow-up for 12 weeks following the dose of TRP 8802. The total participation in the study will be up to approximately 5 months.

NCT ID: NCT05026411 Active, not recruiting - Eating Disorders Clinical Trials

Food Reward Circuit Change by Orthodontics

DTI
Start date: September 1, 2019
Phase: N/A
Study type: Interventional

It has been described in obese individuals in which decreased basal metabolism as well as dopaminergic changes in the prefrontal cortex and striatum parallels the increased activation of reward brain regions in response to delicious food cues. Our aim is to explore different neurobehavioral dimensions of food choices and motivational processes in the light of this information, and to reveal whether these behaviors can be changed by operant conditioning with neuroimaging methods for phenotypes at risk.

NCT ID: NCT04779216 Active, not recruiting - Anorexia Nervosa Clinical Trials

Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa

Start date: September 20, 2021
Phase: Phase 3
Study type: Interventional

This protocol is a randomized, double-blind, placebo-controlled clinical trial which aims to investigate the effect of romosozumab on BMD in women with anorexia nervosa. The investigators will also investigate the safety of romosozumab in women with anorexia nervosa. The investigators hypothesize that 12 months of romosozumab administration will result in an increase in bone mineral density, increase in markers of bone formation and decrease in markers of bone resorption, and improvement in bone microarchitecture in osteopenic women with anorexia nervosa compared with placebo. The extension study will offer subjects 12-month administration of open-label alendronate (an oral bisphosphonate) 70 mg once weekly after the initial 12 month administration of romosozumab or placebo. The investigators hypothesize that 12 months of romosozumab followed by 12 months of open-label alendronate will result in a greater increase in BMD compared to 12 months of placebo followed by 12 months of open-label alendronate. Within the group of women who receive sequential therapy with 12 months of romosozumab followed by 12 months of alendronate, the investigators hypothesize that BMD will be maintained between 12 and 24 months while on alendronate.

NCT ID: NCT04745507 Active, not recruiting - Anxiety Disorders Clinical Trials

Implementation, Efficacy and Costs of Inpatient Equivalent Home-Treatment in German Mental Health Care

AKtiV
Start date: January 1, 2021
Phase:
Study type: Observational

The "inpatient-equivalent home treatment"(IEHT) according to §115d SGB-V is a particular version of the internationally well-known and evidence-based Home Treatment. As a complex intervention, IEHT requires a multi-method evaluation on different levels in the German context. The AKtiV study that is financed by the Innovation Fund of the Federal Joint Committee (proposal ID: VSF2_2019-108) meets this request. In this quasi-experimental study with a propensity score-matched control group, we assess and combine quantitative and qualitative data. Outcome parameters include classical clinical ones such as hospital readmission rates, mental state, and recovery outcomes. In addition, it evaluates issues concerning the right target population, treatment processes, implementation strategies, and factors associated with positive outcomes. The study takes into account the perspective of patients, relatives, staff as well as decision makers in politics and administration. Therefore, we expect the results to be relevant for a broad audience and to contribute to further refinement and adaption of the model.

NCT ID: NCT04636840 Active, not recruiting - Eating Disorders Clinical Trials

Leveraging Social Media to Identify and Connect Teens With Eating Disorders to a Mobile Guided Self-Help Mobile Intervention

Start date: December 18, 2020
Phase: Phase 1
Study type: Interventional

Clinical or subclinical eating disorders (EDs) impact 10% of individuals in their lifetime and are marked by significant functional impairment, early mortality, chronicity, and emotional distress. ED symptoms often emerge in adolescence, with peak onset age in the teenage years. Early recognition and treatment of these devastating illnesses are needed to prevent long-term consequences and a chronic course. Most (80%) individuals with EDs, including teens with EDs (TwEDs), do not receive treatment. Due to major barriers to access and to the delivery of treatment for TwEDs, there is a need for a new model of service delivery that can identify and help TwEDs. We demonstrated our ability to harness social media to identify and efficiently recruit large numbers of TwEDs. Our team has successfully developed a guided self-help cognitive behavioral therapy (CBT)-based mobile app for previous studies and have adapted this app to address the specific needs of TwEDs. In proposed study, we will test this updated mHealth intervention, which includes simplified language and tailored content relevant to adolescent issues and a social networking feature designed to facilitate group exchanges. This mHealth intervention will be investigated among 161 TwEDs recruited from Instagram/Facebook to test preliminary efficacy and feasibility of this mHealth intervention to improved eating disorder symptoms among TwEDs not currently engaged in treatment. We will also garnering feedback via a mixed methods approach on the efficiency, technical effectiveness, and satisfaction with mHealth intervention content and features. Participants will be randomized to one of 3 study arms, including a control group (self-help version of the app), a group with access to the coached mobile app only, and a group with access to the coached mobile app plus social networking feature. We hypothesized that those with access to the coached mobile app intervention will have improved ED outcomes in comparison to the control group, and that those with access to the additional social networking feature will have the most improvement in ED symptoms out of all three groups.

NCT ID: NCT04632069 Active, not recruiting - Oxidative Stress Clinical Trials

NAC +taVNS in IDM Who Are Poor Oral Feeders

Start date: August 12, 2021
Phase: Early Phase 1
Study type: Interventional

Infants of diabetic mothers who are failing to learn oral feeding by term age equivalence have greater CNS oxidative stress, which interact to predict poor neuroplasticity response to transcutaneous vagus nerve stimulation paired with oral feeding. We propose treating the oxidative stress in IDM infants prior to initiating taVNS, with an FDA-approved antioxidant (N-acetylcysteine, NAC) to improve CNS oxidative stress, which in turn regulates expression of many genes including BDNF, that may enhance motor learning.

NCT ID: NCT04625959 Active, not recruiting - Bulimia Nervosa Clinical Trials

Optimizing Mindfulness and Acceptance Based Behavioral Treatment for Bulimia Nervosa and Binge Eating Disorder

Start date: June 5, 2020
Phase: N/A
Study type: Interventional

The current study will use a full factorial design to identify the independent and combined effects of four core MABT components when combined with standard behavioral treatment for BN and BED. The primary aim of the study will be to evaluate the independent efficacy of Mindful Awareness, Distress Tolerance, Emotion Modulation, and Values-Based Decision Making on eating pathology (at posttreatment and at 6 and 12-month follow-ups). Secondary aims will be (1) to test target engagement of each MABT component, i.e., to confirm that each treatment component impacts both the variable which it targets and self-regulation and that improvements in these are associated with improvements in outcomes and (2) to test the hypotheses that the efficacy of each component is moderated by related baseline deficits in self-regulation (e.g. individuals with worse distress tolerance at baseline are most likely to benefit from conditions that include the Distress Tolerance component). A final exploratory aim will be to quantify the component interaction effects, which may be partially additive (because components overlap and/or there is diminishing return), fully additive, or synergistic (in that components may partially depend on each other).

NCT ID: NCT04424745 Active, not recruiting - Clinical trials for Binge-Eating Disorder

Neuromodulation With Attention Bias Modification Training for Binge Eating Disorder

TANDEM
Start date: February 25, 2021
Phase: N/A
Study type: Interventional

Binge eating disorder (BED) is a common and disabling eating disorder (ED) which has significant effects on psychological wellbeing, physical health, and quality of life. Talking therapies, most notably cognitive behaviour therapy (CBT), are presently recommended for the treatment of BED. However, outcomes from treatment are inadequate. Therefore, there is a need for development of new treatments. This study aims to investigate the feasibility of combining Attention Bias Modification Training (ABMT) and Transcranial Direct Current Stimulation (tDCS) to reduce binge-eating behaviour and craving for food in people with BED. ABMT is a computerised training that seeks to alter responses towards food that people are not consciously aware of. During ABMT, participants are trained to 'look towards' low-calorie food and 'look away' from high-calorie food. TDCS is a safe, well tolerated, non-invasive form of brain stimulation which is suitable for supervised self-administration. It stimulates specific brain areas using a mild electrical current (2 mA) via small electrodes placed on the scalp. In this study, participants will be randomly allocated to receive either ABMT with real tDCS or ABMT with sham tDCS. ABMT and real/sham tDCS will be delivered simultaneously, i.e. participants will engage in ABM training whilst receiving tDCS. All participants will be remotely supervised by the study researcher for the duration of each treatment session. Biological male and female adults (aged 18-60) of any gender will be eligible to take part if they have a DSM-V of BED and they are overweight or obese. Taking part will involve completing 10 sessions of combined ABMT and real or sham tDCS over 2-3 weeks. Binge frequency, food craving and other outcomes will be measured at the start of the study, end of the study, and at the 6-week follow-up.

NCT ID: NCT04325308 Active, not recruiting - Clinical trials for Microbial Colonization

Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk

Start date: August 13, 2020
Phase: N/A
Study type: Interventional

The central hypothesis of this clinical trial is that, in extremely preterm infants, protein-enriched human milk diets compared to usual human milk diets during the first 2 weeks after birth increase fat-free mass (FFM)-for-age Z scores and promote maturation of the gut microbiome at term corrected age.