Clinical Research Directory

Testing an Intervention for College Students With Food Insecurity and Binge Eating

This study is being conducted to test a new intervention. We are interested in whether it is easy to use and complete and whether you find it helpful in reducing concerns about your eating.

Sleep Optimization to Aid in Recovery Digital Program

The purpose of this pilot study is to evaluate the usability and feasibility of SOAR (Sleep Optimization to Aid Recovery), a brief and self-guided digital program designed to share evidence-based sleep hygiene information with individuals seeking treatment for an eating disorder. The SOAR program delivers well-established recommendations promoted by the National Sleep Foundation and other professional sleep health organizations. The purpose of this study is not to test a new treatment or intervention per se, but rather to examine how effectively this existing information can be delivered through a digital platform to people preparing for or engaged in eating disorder treatment. By providing these evidence-based strategies in a user-friendly and accessible format, SOAR aims to support healthy sleep habits that may enhance overall well-being and facilitate recovery. The investigators will compare SOAR against a control condition, which would be no intervention (treatment-as-usual). Participants randomized to the control will receive access to SOAR after the follow-up period has ended, if they wish to use it.

Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents: a Randomized Controlled Trial With Long-term Follow-up

The main purpose is to investigate the effectiveness of a 10-week multicomponent camp intervention to reduce BE behavior in children and adolescents and explore in a randomized controlled setting if a parent-based BED-intervention has any add-on effect, attenuating the development of BE behavior in this sample. The study will include an initial follow-up assessment scheduled 10-12 weeks after camp completion and plans for long-term follow-up assessments one, three and five years after inclusion. Overall, we hypothesize that the multicomponent camp intervention will effectively reduce BE behavior in children and adolescents. Furthermore, we hypothesize that participants whose parents are randomized to receive the parental BED intervention will show a lower prevalence of BE behavior one year after the camp intervention compared with children whose parents receive standard care.

Project REST: Regulation of Eating and Sleep Topography

Overweight/obesity and inadequate sleep are prevalent, and frequently co-occurring, health risks among children, both of which are associated with serious medical and psychosocial health complications including risk for cardiovascular disease. Although the investigator's data suggest that disrupted or shortened sleep may be causally associated with increased energy intake and weight gain in children, and with self-regulation and neural response to food cues in adults, understanding of mechanisms involved in the sleep/eating association is incomplete, thereby impeding development of targeted, optimally timed intervention strategies. The proposed mechanistic clinical trial aims to assess the effects of an experimental sleep manipulation on eating-related self-regulation and its neural substrates, and on real-world eating behavior, among children with overweight/obesity, which will help guide research efforts towards the refinement of prevention and intervention strategies targeting sleep and its eating-related correlates to curb weight gain throughout development.

Mindful Motivation for Reducing Binge Eating

The aim of this study is to test how acceptable and feasible a new eating intervention is in people with overweight and binge eating. This intervention combines mindful eating with motivational interviewing to target binge eating. The main questions this clinical trial aims to answer are: How well do participants accept the new intervention (acceptability)? Is the intervention practical and easy to implement (feasibility)? In this trial researchers will compare the new eating intervention (motivational interviewing for mindful eating + digital meditation) to an active control (digital meditation) to see if the intervention can help reduce binge eating. Participants will: 1. Take online questionnaires at four different time points 2. Provide body composition and samples to measure glucose levels 3. Meditate for at least 10 minutes a day 4. If assigned to the Mindful Motivation group, 8 weeks of brief counseling

COR Protocol for the Treatment of Binge Eating in Chilean Adults (COR)

The goal of this clinical study is to learn whether a brief online psychological program called COR can be delivered in a feasible and acceptable way for adults who experience recurrent binge eating. The main questions this study aims to answer are: * Is the COR program acceptable to participants, in terms of satisfaction, adherence, and dropout rates? * Is the COR program feasible to deliver online, including recruitment, retention, and completion of sessions and questionnaires? * Do participants show preliminary changes over time in binge eating-related distress and emotional well-being? Participants in this study are adults who experience recurrent episodes of binge eating. They will take part in an individual online intervention that includes eight weekly sessions, a brief pre-session, and a follow-up session one month after the end of treatment. During the study, participants will: * Attend weekly online sessions focused on understanding binge eating, emotions, and the relationship with food and the body * Practice simple exercises to help manage emotional distress and food-related urges * Complete short questionnaires before, during, and after the intervention to describe their experiences The information from this study will help researchers understand whether this type of intervention can be used in future, larger studies and in real-world clinical settings.

Trial to Optimize Just-in-Time Adaptive Intervention for Binge Eating & Weight-related Behaviors

The purpose of this study is to conduct a micro-randomized trial to learn which evidence-based targets within a mobile intervention for binge eating and weight-related behaviors are most impactful for which people and in what sequence.

Naltrexone Neuroimaging in Teens With Eating Disorders

Using a randomized, placebo-controlled, crossover study, this study will evaluate functional magnetic resonance imaging (fMRI) as a pharmacodynamic biomarker of opioid antagonism in adolescents with eating disorders. The hypothesis is that fMRI will be able to detect acute reward pathway modulation by naltrexone (an opioid antagonist) in pre-defined regions of interest (anterior cingulate cortex, nucleus accumbens, dorsolateral prefrontal cortex).

Testing SHAPE: A Single-Session Intervention Targeting Binge Eating in Women Through Assessment and Values-Based Strategies

The goal of this controlled trial is to learn whether a brief single-session intervention (SSI) can reduce binge eating symptoms by targeting overvaluation of weight/shape in women with recurrent binge eating. The main questions it aims to answer are: * Does assessment alone reduce binge eating severity and overvaluation of weight/shape compared to a control group undergoing minimal assessment? * Does adding a values-based reflection and goal-setting component (the full SHAPE intervention) add benefits beyond the assessment alone? Researchers will compare three groups: 1. assessment-only, 2. full SHAPE intervention, and 3. minimal assessment control to see if both active conditions outperform the control, and whether the full intervention adds any benefits beyond the assessment itself Participants will: * Complete a semi-structured eating disorder assessment (Eating Disorder Examination) * Depending on assignment, also complete a values-based reflection and goal-setting exercise with psychoeducation * Complete follow-up assessments evaluating binge eating severity, overvaluation of weight/shape, clinical impairment, binge frequency, and related outcomes.

Efficacy of Juniver, a Digital Self-help Intervention, on Symptoms of Eating Disorders: A Randomised Controlled Trial

This project aims to assess the efficacy of the Juniver program on symptoms of eating disorders via a randomised controlled trial. The Juniver program is a self-help intervention for eating disorders delivered digitally, through an iPhone app. It features three components: an evidence-based curriculum, interactive tools, and moderated peer support groups. These three components integrate the evidence for (a) Cognitive-Behavioural Therapy (CBT) and Dialectical Behaviour Therapy for eating disorders; (b) Just-in-Time Adaptive Intervention; and (c) peer mentorship as an adjunct intervention for the treatment of eating disorders. The program was developed by the Juniver team made up of people with lived experience with eating disorders and professional experience in digital health, a panel of neuroscientists and experts specialising in eating disorders, and direct research with 500 participants. This trial aims to investigate the impact of the Juniver program on self-reported eating disorder symptoms, as well as on symptoms of depression, anxiety, psychosocial impairment associated with eating disorders, and perceived stress. This will occur via a randomised controlled trial comparing Juniver to a wait-list control condition over a 12-week period, with further evaluation of the effects of Juniver up to 24-weeks.

Project VIBE: Virtual Intervention for Binge Eating in Adolescents

The aim of this project is to pilot test a novel mobile app intervention for adolescents with dysregulated eating behaviors and elevated weight status. This intervention will incorporate evidence-informed strategies targeting self-regulation into cognitive-behavioral treatment for maladaptive eating. Adolescents will use the app for 16 weeks and provide feedback on its usability and effectiveness in managing dysregulated eating.

Treating Binge Eating and Obesity Digitally in Black Women

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.

Preventing Type 2 Diabetes in Black Emergent Adult

Black Americans are disproportionately affected by diabetes, with nearly double the rates of type 2 diabetes mellitus (T2DM), compared to non-Hispanic White adults. Though numerous factors affect these disparities, one modifiable risk factor may be that of binge eating (BE), which increases risk for binge-eating disorder (BED), which is associated with severe obesity, and often precedes a T2DM diagnosis, beginning in childhood or adolescence. Nearly 30% of Black women with obesity report binge eating episodes. Furthermore, given that binge and overeating may disparately increase the odds of obesity in Black adults (15-fold increase vs. 6-fold increase in White adults), reducing this behavior will be critical to prevent continued disparities in T2DM diagnosis. Given that Black women have the highest rates of obesity in the nation (57%), report disparate rates of weight gain between young adulthood and mid adulthood, and report disparate rates of emotional eating in adolescence, which is a risk factor for BE, one pathway to reducing disparities in T2DM risk in Black women may be to reduce binge eating and prevent weight gain in emerging adulthood (ages 18-25).

Improving Appetite Self-Regulation in African American Adults With Type 2 Diabetes

The purpose of this 6-month randomized clinical trial is to examine the feasibility of recruitment, attendance, retention, program adherence, and satisfaction of a digital application designed, Centering Appetite to improve glucose scores (HbA1c) and binge eating in African American adults with type 2 diabetes. Intervention participants will receive type 2 diabetes education and web-based lessons on appetite self-regulation. Participants will also receive a Fitbit to monitor daily physical activity. The investigators will follow up with participants at six months.

Enhanced Cue Exposure Therapy for Negative Emotional Eating

The current study aims to evaluate the efficacy of Enhanced Cue Exposure Therapy (E-CET) in reducing negative emotional eating (NEE), compared to an active control intervention, behavioral lifestyle intervention (BLI), in a parallel-group, participant-blinded, randomized controlled trial. The secondary aim is to evaluate whether changes in conditioned stimulus-unconditioned stimulus (CS-US) expectancies mediate the changes in NEE.

The ITA Model of Integrated Treatment of Eating Disorders

This is a naturalistic study implementing a routine assessment to monitor the evolution of the patients with eating disorders being treated in various centers of "ITA salud mental" in Spain.

Transcranial Magnetic Stimulation and Inhibitory Control Training to Reduce Binge Eating: Brain and Behavioral Changes

People with BE are characterized by high impulsivity, high levels of craving for high-calorie foods, deficits in inhibitory control, and maladaptive decision making. These characteristics are related, at brain level, to alterations in the activation of areas such as the dorsolateral prefrontal cortex (DLPFC) and ventromedial prefrontal cortex (vmPFC) among other brain areas and their connectivity. The investigators propose an intervention that seeks to target these issues. Thus, the present study aims to characterize the effects of neuromodulation with intermittent theta burst stimulation (iTBS) of the DLPFC or the vmPFC in combination with inhibitory control training to produce brain, cognitive and behavioral changes, and modify altered biological parameters in people with BE. Participants will be randomly allocated to one of three groups: 1) a group that will receive active iTBS of the DLPFC together with inhibitory control training with a food Go/NoGo paradigm, and 2) a group that will receive active iTBS of the vmPFC together with inhibitory control training with a food Go/NoGo paradigm, and 3) an active control group that will receive sham iTBS together with inhibitory control training with a food Go/NoGo paradigm. The investigators hypothesized that neuromodulation with iTBS applied to DLPFC or vmPFC will modify the dynamics of different brain circuits associated with binge eating. Neuromodulation of the DLPFC or vmPFC in combination with inhibitory control training, will be associated with: (i) decreased appraisal of unhealthy foods, (ii) reduced food craving, (iii) improved eating behavior, (iv) modified brain connectivity and activation both at rest and linked to task performance with food stimuli, (v) a decrease in the frequency and intensity of binge eating, (vi) improved emotional symptoms and emotional eating (depression, anxiety, emotional regulation, emotional eating, reward-related eating, non-homeostatic eating), (vii) improved cognitive abilities (motor and cognitive inhibition, delay of gratification, impulsivity, working memory, cognitive flexibility and decision making), (viii) changes in biological parameters associated to the interventions (plasma and microbiota), and (ix) advantages in cost-effectiveness and cost-utility based on economic evaluation analyses.

Brief Binge Eating and Drinking Online Intervention

This pilot project targets both binge drinking and binge eating behavior in college students through a mobile-based online program that provides students with evidence-based intervention material designed to reduce the incidence of both behaviors and encourage students to seek more formal in-person counseling.

EMOTE: a Smartphone Application for Binge Eating Based on DBT Skills

Binge eating, whether formally diagnosed or occurring at subthreshold levels, is associated with adverse health consequences and decreased quality of life. Access to accessible, cost-effective interventions that effectively address binge eating episodes is critical for individuals with this condition, and smartphone applications have demonstrated promise in treating binge eating and related disorders. This study aims to evaluate the efficacy of eMOTE, a novel smartphone application for binge eating based on Dialectical Behavior Therapy (DBT) skills. For this purpose, a randomized controlled trial will be conducted in which women who self-report binge eating episodes will be randomly assigned to the app intervention group or a waiting list group.

Identifying Effective Technological-based Augmentations to Enhance Outcomes From Self-help Cognitive Behavior Therapy for Binge Eating

The purpose of this study is to test the feasibility, acceptability and efficacy of two technology-based intervention systems (including an Advanced Digital Data Sharing (ADDS) with Coaches or a smartphone-based just-in-time, adaptive interventions (JITAIs) system) for improving treatment adherence, skills utilization and binge eating when used in conjunction with a self-help cognitive behavior therapy \[CBT\] delivered via a smartphone application \[app\]). The study is being conducted to test a novel approach to providing evidence-based treatment for binge eating without clinician support in a routine clinical setting.

Integrative Intervention Strategies for Binge Eating in Patients With Overweight or Obesity

The main goal of the clinical trial is to compare the short- and long-term outcomes of three 12-week interventions among outpatients with overweight/obesity and binge eating (BE): 1. treatment-as-usual for weight loss (TAU); 2. combined TAU and guided self-help for improving eating behaviors (TAU+GSH); 3. combined TAU, GSH, and biofeedback (TAU+GSH+BF). The primary outcomes will be self-reported reduction of days with objective BE episodes (OBEs). The secondary outcomes will be impulsivity, emotion dysregulation, interoceptive awareness, distress, physiological correlates of arousal (skin conductance and heart rate variability), and inflammatory biomarkers. The TAU+GSH arm is expected to be comparable to the TAU+GSH+BF arm in reducing the number of days with OBEs but is expected to be significantly less effective in improving secondary outcomes (impulsivity, emotional dysregulation, interoceptive awareness, distress, physiological inflammatory markers). The TAU arm is expected to show significant inferiority regarding the primary and secondary outcomes and cost-effectiveness compared to the TAU+GSH and TAU+GSH+BF conditions.

Feasibility of a Digital Therapeutic for Adults With Binge Eating and Obesity

The primary objective of this study is to test the feasibility of a digital therapeutic to address comorbid binge eating and obesity in adults.