Binge Eating BehaviourNCT07823153
Biobehavioral Mechanisms of Activity and Loss of Control Eating in Children
A study testing Go/No-go task, Visual food task and Emotion regulation task in people with Binge Eating Behaviour and Eating Disorders, run by The University of Texas at Dallas at 3 sites in United States.
Trial summary
Loss of control eating in children and adolescents is associated with a host of negative physical and psychological health outcomes and a prognostic marker for development of eating disorders. Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Binge Eating Behaviour, Eating Disorders, Physical Activity
- What is being tested?
- Go/No-go task, Visual food task and Emotion regulation task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Jan 2027to 1 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Can read and speak English.
- At-risk for loss of control eating will be over-sampled (representing minimum 30% of sample) to capture sufficient variability across time in loss of control eating, the online screener will include the Eating Disorders Examination Questionnaire-Short Parent Version (EDE-QS-P). At-risk for loss of control eating is defined on the EDE-QS-P as a global score at least 1 standard deviation above the mean EDE-QS-P score observed among parents of children without eating disorders (i.e., global score > 1.2).
Who cannot join
- Diagnosis of an eating disorder other than binge-eating disorder or subthreshold binge-eating disorder (i.e., binge-eating disorder of low frequency/limited duration), or presence of compulsive exercise as assessed by the Child Eating Disorder Examination.
- Health issues that limit physical activity.
- Intellectual disability (assessed with the Child and Adolescent Intellectual Disability Screening Questionnaire embedded within the online eligibility screener), which would interfere with completing ecological momentary assessment.
- Pregnancy.
- Acute suicidality (screened using item 9 on the Patient Health Questionnaire-Adolescent).
- Presence of conditions that would make fMRI unsafe (e.g., pacemaker), as assessed by an MRI screening form.
Show all 9Show fewer
- Undergoing eating disorder or weight loss treatment.
- Classified as underweight by a body mass index percentile <5% adjusted for sex and age (body mass index z-score<-2.0).
- Schizophrenia, substance use disorders, severe neurological disorder (e.g., epilepsy, brain injury), or diabetes (per caregiver self-report).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
George Mason University
Fairfax, Virginia, 22030
Tyler Mason, PhD, 7039939709, tmason24@gmu.edu
University of Southern California
Los Angeles, California, 90089
Shan Luo, PhD, 2134939331, shanluo@usc.edu
University of Texas at Dallas
Richardson, Texas, 75080
Kathryn Smith, PhD, (972) 883-4997, kathryn.smith@utdallas.edu
About this study
Loss of control eating in children and adolescents is associated with a host of negative physical and psychological health outcomes and a prognostic marker for development of eating disorders. However, there is a lack of longitudinal research investigating the developmental processes contributing to loss of control eating in youth. While physical activity, sedentary behavior, and self-regulation have been linked to the regulation of eating, no research has examined the mechanistic processes by which these domains may together impact loss of control eating during childhood and adolescence. Furthermore, given that these factors (i.e., activity, self-regulation, and eating behavior) vary considerably from moment-to-moment, it is imperative to utilize methodology that can capture momentary, real-time fluctuations in these domains. Therefore, the current study proposes to use a biobehavioral, multi-method approach integrating neuroimaging, accelerometry, neurocognitive assessments, and ecological momentary assessment (EMA) to study how physical activity and sedentary behavior patterns and self-regulation influence loss of control eating and related eating disorder psychopathology from late childhood to adolescence, which is a critical transitional developmental period. Male and female children aged 10-12 at baseline (N=200) will be recruited to complete annual assessments for 3 years.
Aim 1 (momentary) - Examine momentary associations between physical activity patterns, self-regulatory mechanisms (i.e., inhibitory control, emotion functioning, and food-related reward anticipation) and loss of control eating in daily life using multi-method ambulatory assessment. Hypothesis 1a: Momentary decreases in physical activity and increases in sedentary behavior, compared to one's usual level, will be associated with increases in loss of control eating. Hypothesis 1b: Momentary decreases in self-regulatory mechanisms (i.e., decreases in inhibitory control, emotion regulation, and positive affect, and increases in negative affect and food-related reward anticipation) will explain (i.e., mediate) associations between decreases in physical activity/increases in sedentary behavior and subsequent increases in loss of control eating.
Aim 2 (longitudinal) - Examine longitudinal associations between physical activity patterns, self-regulatory mechanisms, and binge eating and related eating pathology (i.e., loss of control eating, binge episodes, eating disorder onset, global eating psychopathology) using multimethod ambulatory assessment and functional magnetic resonance imaging (fMRI). Hypothesis 2: Across a three-year follow-up, children who show greater decreases in physical activity and increases in sedentary behavior, compared to other children, will demonstrate greater decreases in self-regulatory capacity (i.e., decreases in inhibitory control, emotion regulation, and positive affect, and increases in negative affect and food-related reward anticipation), which in turn will predict increases in binge eating and related eating pathology by year three. The hypothesis will be evaluated using self-regulation indices measured via EMA (Hypothesis 2a) and via task-evoked neural activations during fMRI (Hypothesis 2b).
Read the detailed description
The study involves a clinical interview, physical measurements, questionnaires, brain imaging (MRI), and a 10-day monitoring period during which participants will complete mobile phone surveys and physical activity will be monitored. Study sessions occur once a year for 3 years and will include virtual and in-person visits, each of which will last between 1-2 hours.
Procedure:
Screening - Study advertisements will direct interested parents/legal guardians of children to an online screening (via QR code). The online screening survey will be administered by REDCap and completed on their device. The screener will also include a document with mental health and eating disorder referral information because the screening process may raise awareness of these concerns. Potentially eligible families will be contacted via email or phone to set up a time for the study visit at UTD.
Study visits - Participants will complete 3 annual data collection visits that will be 12 months apart (Year 1, 2, and 3). During Years 1-2, participants and parents/guardians will complete a virtual session with researchers followed by an in-person visit at the UTD Brain Health Imaging Center (BHIC) where participants will complete the neuroimaging (fMRI) protocol. The Year 3 study visit will take place at Dr. Smith's research laboratory in the UTD Department of Psychology. During scheduling of study visits involving fMRI (Years 1-2), families will also be informed that participants will be asked to abstain from eating for 4 hours prior to fMRI to standardize procedures and capture representative physiological states prior to eating meals (during which inhibitory control, emotion regulation, and reward processing may influence subsequent eating behavior). We will provide mental health and eating disorder referral information to all families at study visits because the assessment process may raise awareness of concerns the parent was not previously aware of.
Informed by published ethical guidance for pediatric research developed for the NIH-funded Adolescent Brain and Cognitive Development (ABCD) study, parents will not be shown their child's individual interview or survey responses, with two exceptions: (1) current suicidal ideation or self-harm, and (2) eating disorder symptoms indicating the child is at serious medical or psychiatric risk (e.g., significantly low weight/weight loss or dangerous compensatory behaviors such as frequent purging). This will be operationalized as evidence of:
- BMI percentile below the 5th percentile for age/sex
- Rapid and significant weight loss
- Self-report during the clinical interview indicating compensatory behaviors (self-induced vomiting, laxative/diuretic misuse, fasting, compulsive exercise) occurring several times per week For consistency, and to protect the validity of adolescent self-report, we align the threshold of disclosing eating disorders with the same imminent/serious-risk standard as outlined in the ABCD study.
Year 1:
Virtual session - At the first virtual session, parents/guardians and participants will complete the initial informed consent and assent process with researchers virtually. During the informed consent process and in the consent form, it will also be explained that participants may be ruled out after enrollment if they do not meet study eligibility criteria (e.g., based on information provided during the clinical interview or their height/weight) or if MRI is not appropriate for participants due to contraindications. Following the informed consent process, participants' eligibility will be confirmed based on a clinical interview (Child Eating Disorder Examination administered virtually) and anthropometric (height/weight/waist circumference) measurements at the in-person visit. During the virtual session, participants and parents/guardians will complete self-report surveys online and receive mobile phone and accelerometer instructions.
In-person visit (UTD Brain Health Imaging Center) - Participants will complete a neuroimaging protocol and anthropometric assessments at the UTD Brain Health Imaging Center (accompanied by their parent/guardian), which will be scheduled within 2 weeks of the virtual session.
10-day data collection - Over the next 10 days after the in-person visit, participants will proceed through a 10-day data collection period in their daily life. This includes an ecological momentary assessment (EMA) protocol during which participants will be asked to proceed with their daily routines as normal. Participants will also wear an accelerometer across all 10 days. Staff will contact families by phone during the 10-day monitoring period to encourage compliance and address technical issues.
Year 2:
Virtual session - The consent and assent process will be repeated. Participants will repeat the clinical interview, and participants and parents/guardians will complete online surveys.
In-person visit (UTD Brain Health Imaging Center) - Participants will repeat the neuroimaging protocol and anthropometric assessments at the UTD Brain Health Imaging Center (accompanied by their parent/guardian), which will be scheduled within 2 weeks of the virtual session.
10-day data collection - Participants will repeat the 10-day data collection period.
Year 3:
In-person visit (UTD Psychology Department) - The consent and assent process will be repeated. Participants will repeat the clinical interview, anthropometric assessments, and participants and parents/guardians will complete online surveys.
10-day data collection - Participants will repeat the 10-day data collection period.
Data collection measures will include the following:
Anthropometric assessment (Years 1-3) - At each in-person study visit, height, weight, and waist circumference of the participant will be measured in duplicate using an electronically calibrated digital scale and professional stadiometer to the nearest 0.1 kg and 0.1 cm, respectively. Blind weight will be measured (i.e., they will not see their weight) to mitigate any distress or reactivity. These measurements will be completed at the BHIC in Years 1-2, and in Dr. Smith's research laboratory during Year 3.
Interview (Years 1-3) - Each year, participants will complete a clinical interview 9Child Eating Disorder Examination [ChEDE] diagnostic modules). This interview will be administered virtually in Years 1-2 and in-person at UT Dallas in Year 3. The ChEDE will be used to confirm eligibility at Year 1 and for descriptive purposes in Years 2-3.
Self-report questionnaires (Years 1-3) - Participants will report on their gender identity and sexual orientation, and they will complete a series of self-report questionnaires online.
Neuroimaging (Years 1-2) - In Years 1 and 2, participants will complete an fMRI protocol at the BHIC.
Prior to fMRI participants will also complete online surveys that assess exercise over the previous 24 hours, as well as current hunger state (using a visual analog scale from 0 [not hungry at all] to 10 [very hungry]) that will be considered as covariates in analyses. Participants will be asked to confirm they have abstained from eating for 4 hours prior to MRI. Parent/guardians will be asked to confirm eating abstinence, and imaging will be done at the end of the study session (i.e., after interview/questionnaire assessments) to ensure children have not eaten recently.
After completing pre-scan measures, participants will complete a practice session in the MR (magnetic resonance) simulator to familiarize participants with the scanning environment. Then they will complete the MRI protocol which includes complete three tasks in a randomized order while brain activity is being recorded with fMRI. Tasks will be projected on a screen located at the rear of the magnet and viewed via a head coil mirror. A response keypad will record task responses. The neuroimaging protocol will first acquire T2, T1, field map, and scout scans (~8-10 min) then two runs of the go/no-go task (~5 min/run), two runs of the visual food task (~6 min/run), and four runs of the emotion regulation task (~4 min/run), totaling 46-48 minutes of scanning time. Participants may take breaks as needed between runs.
Ecological momentary assessment (EMA; Years 1-3) - Across the 3 years, participants will complete an annual 10-day EMA protocol in their natural environment using an EMA application for smartphones. Participants will use a smartphone (either their own or one provided) to complete surveys, up to 4 times during non-school time on weekdays (morning wake-up time; 3:30pm-8pm) and up to 7 times on weekend days (9am-9pm). EMA measures will be collected using (1) signal-contingent reporting, which requires youth to complete assessments occurring at various times throughout the day in response to semi-random prompts, and (2) event-contingent reporting, which requires youth complete a survey after they engage in an eating episode. Semi-random prompts will be generated in stratified random sampling windows, with one prompt randomly occurring during each window. Youth will not complete random surveys on weekdays while at school to prevent classroom interruptions. However, they will be asked to record lunch on weekdays at school. At each semi-random signal, participants will also be prompted to report any missed eating episodes. Participants will receive information and training in the completion of EMA reports and behavioral tasks on the smartphone. Participants will be instructed not to complete entries at times when they feel they are not able or when safety is a concern. However, participants will be encouraged to complete the entry as soon as possible when able and will receive reminder prompts. Up to two reminder prompts will be sent within 30 minutes of the initial prompt, after which time the survey will close. Staff will call participants and their caregivers halfway through the protocol to give compliance feedback and to answer questions.
Ambulatory assessment (Years 1-3) - Physical activity and sedentary time will be measured using wrist-worn accelerometers. Participants will wear accelerometers continuously across 10-day monitoring period each year. Activity counts will be recorded in 10-second epochs. Participants will be provided with an accelerometer at each of the in-person visits, and parents/guardians will be provided with a self-addressed prepaid package to return the device after the 10-day monitoring period.
- Conditions
- Binge Eating Behaviour, Eating Disorders, Physical Activity, Functional Magnetic Resonance Imaging (fMRI), Ecological Momentary Assessment, Loss of Control Eating
- Being tested
- Go/No-go task, Visual food task, Emotion regulation task
- Keywords
- binge eating behavior, eating disorders, physical activity, functional magnetic resonance imaging (fMRI), ecological momentary assessment, loss of control eating
- Medical subject headings
- Binge-Eating Disorder, Feeding and Eating Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Go/No-go taskBehavioural
This task will assess participants' general and food-related inhibitory control.
Participants will be instructed to press a button to "go" cues and withhold responses to "no-go" cues. In one run, low caloric food images will be the "go" cues, and high caloric food images will be the "no-go" cues. In another run, images of school supplies will be the "go" cues, and toys will be the "no-go" cues.
Visual food taskBehavioural
This task will measure participants' food-related reward processing and food cue reactivity. Participants will view food and non-food images, and brain activity will be assessed while viewing images.
Emotion regulation taskBehavioural
This task will assess participants' ability to modulate negative affect in response to emotionally evocative images. Negative and neutral pictures will be selected from the IAPS database using criteria analogous to prior research. At the start of each trial, an instruction word will be presented ("decrease" or "look") for 4 sec, after which a picture will be presented for 8 sec. The pictures will be negative if the instruction is "decrease" (emotion regulation instruction), negative or neutral if the instruction is "look" (non-regulation). This is followed by a rating of negative affect ranging from 1="'weak" and 4="strong" (4 sec), and then the word "relax" (4 sec). The combinations of instruction and pictures yields 3 trial types: decrease negative (reappraisal), look negative (nonregulation) and look neutral (non-emotional). A total of 72 trials will be given (24 of each trial type) over 4 runs (~4 min/run).
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Participants will be assigned all three behavioral tasks. Receives: Behavioral: Go/No-go task; Behavioral: Visual food task; Behavioral: Emotion regulation task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhibitory control
The behavioral outcome will be unsuccessful inhibition during no-go trials (commission error rate; i.e., the number of failures of inhibition divided by the total number of no-go trial), calculated separately for food and non-food. Changes in brain activity (through fMRI) will also be examined. For each condition (i.e., food and non-food stimulus blocks), analyses will evaluate contrast of successful no-go versus implicit baseline (fixation cross) and successful no-go versus unsuccessful no-go trials. Percent change in BOLD response within priori regions of interest (ROIs) will be extracted from these contrasts and used in subsequent analyses. ROIs (based on prior research) will include the inferior frontal gyrus (IFG), ventromedial prefrontal cortex (vmPFC), dorsolateral prefrontal cortex (dlPFC), and ventrolateral prefrontal cortex (vlPFC), as defined by the Harvard-Oxford Cortical Structural Atlas.
Measured: Baseline during visit 1, and one year later at visit 2
Food-related reward processing
The outcome measure will assess changes in brain activity, as measured by fMRI, during exposure to food and non-food images. A general linear model will include three regressors: high-calorie food stimuli, low-calorie food stimuli, and non-food stimuli. Analyses will examine contrasts comparing food stimuli (combined high-calorie and low-calorie food conditions) with non-food stimuli to evaluate differences in BOLD activation within a priori regions of interest (ROIs). Percent change in BOLD signal within these ROIs will be extracted and used in subsequent analyses. Based on prior meta-analytic findings, ROIs will include regions implicated in reward and motivation (amygdala, orbitofrontal cortex, nucleus accumbens, and dorsal striatum), homeostatic regulation (hypothalamus), inhibitory control (dorsolateral prefrontal cortex [dlPFC]), and gustatory processing (insula).
Measured: Baseline during visit 1, and one year later at visit 2
Emotion Processing
The outcome measure will assess changes in brain activity, as measured by fMRI, across three task conditions: decrease negative (cognitive reappraisal), look negative (passive viewing of negative stimuli), and look neutral (passive viewing of neutral stimuli). Analyses will focus on the contrast between the decrease negative and look negative conditions to evaluate neural activity associated with emotion regulation. Percent change in the BOLD response within a priori regions of interest (ROIs) will be extracted from this contrast and used in subsequent analyses. A priori ROIs will include anatomically defined masks of the anterior cingulate cortex (ACC), medial prefrontal cortex (mPFC), ventrolateral prefrontal cortex (vlPFC), and dorsolateral prefrontal cortex (dlPFC), as defined by the Harvard-Oxford Cortical Structural Atlas.
Measured: Baseline during visit 1, and one year later at visit 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start15 Jan 2027 (estimated)
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Binge Eating BehaviourStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Dallas
- Sponsor type
- University, hospital or other
- Collaborators
- George Mason University, University of Southern California, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Dr. Kathryn Smith, The University of Texas at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823153
- Sponsor's protocol ID
- IRB-26-472
- Other IDs
- 1R01MH142463-01, UP-26-00531, STUDY00001354
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified demographic, clinical, survey, ambulatory assessment, and fMRI imaging data.
Publications
Clark DB, Fisher CB, Bookheimer S, Brown SA, Evans JH, Hopfer C, Hudziak J, Montoya I, Murray M, Pfefferbaum A, Yurgelun-Todd D. Biomedical ethics and clinical oversight in multisite observational neuroimaging studies with children and adolescents: The ABCD experience. Dev Cogn Neurosci. 2018 Aug;32:143-154. doi: 10.1016/j.dcn.2017.06.005. Epub 2017 Jun 28.
PubMed 28716389
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobehavioral Mechanisms of Activity and Loss of Control Eating in Children
- ClinicalTrials.gov ID
- NCT07823153
- Acronym / sponsor ID
- IRB-26-472
- Conditions
- Binge Eating Behaviour, Eating Disorders, Physical Activity, Functional Magnetic Resonance Imaging (fMRI), Ecological Momentary Assessment, Loss of Control Eating
- Keywords
- binge eating behavior, eating disorders, physical activity, functional magnetic resonance imaging (fMRI), ecological momentary assessment, loss of control eating
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The University of Texas at DallasUniversity, hospital or other
- Collaborators
- George Mason University, University of Southern California, National Institute of Mental Health (NIMH)
- Study start
- 15 Jan 2027 (estimated)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Loss of control eating in children and adolescents is associated with a host of negative physical and psychological health outcomes and a prognostic marker for development of eating disorders. However, there is a lack of longitudinal research investigating the developmental processes contributing to loss of control eating in youth. While physical activity, sedentary behavior, and self-regulation have been linked to the regulation of eating, no research has examined the mechanistic processes by which these domains may together impact loss of control eating during childhood and adolescence. Furthermore, given that these factors (i.e., activity, self-regulation, and eating behavior) vary considerably from moment-to-moment, it is imperative to utilize methodology that can capture momentary, real-time fluctuations in these domains. Therefore, the current study proposes to use a biobehavioral, multi-method approach integrating neuroimaging, accelerometry, neurocognitive assessments, and ecological momentary assessment (EMA) to study how physical activity and sedentary behavior patterns and self-regulation influence loss of control eating and related eating disorder psychopathology from late childhood to adolescence, which is a critical transitional developmental period. Male and female children aged 10-12 at baseline (N=200) will be recruited to complete annual assessments for 3 years.
Aim 1 (momentary) - Examine momentary associations between physical activity patterns, self-regulatory mechanisms (i.e., inhibitory control, emotion functioning, and food-related reward anticipation) and loss of control eating in daily life using multi-method ambulatory assessment. Hypothesis 1a: Momentary decreases in physical activity and increases in sedentary behavior, compared to one's usual level, will be associated with increases in loss of control eating. Hypothesis 1b: Momentary decreases in self-regulatory mechanisms (i.e., decreases in inhibitory control, emotion regulation, and positive affect, and increases in negative affect and food-related reward anticipation) will explain (i.e., mediate) associations between decreases in physical activity/increases in sedentary behavior and subsequent increases in loss of control eating.
Aim 2 (longitudinal) - Examine longitudinal associations between physical activity patterns, self-regulatory mechanisms, and binge eating and related eating pathology (i.e., loss of control eating, binge episodes, eating disorder onset, global eating psychopathology) using multimethod ambulatory assessment and functional magnetic resonance imaging (fMRI). Hypothesis 2: Across a three-year follow-up, children who show greater decreases in physical activity and increases in sedentary behavior, compared to other children, will demonstrate greater decreases in self-regulatory capacity (i.e., decreases in inhibitory control, emotion regulation, and positive affect, and increases in negative affect and food-related reward anticipation), which in turn will predict increases in binge eating and related eating pathology by year three. The hypothesis will be evaluated using self-regulation indices measured via EMA (Hypothesis 2a) and via task-evoked neural activations during fMRI (Hypothesis 2b).
Detailed description
The study involves a clinical interview, physical measurements, questionnaires, brain imaging (MRI), and a 10-day monitoring period during which participants will complete mobile phone surveys and physical activity will be monitored. Study sessions occur once a year for 3 years and will include virtual and in-person visits, each of which will last between 1-2 hours.
Procedure:
Screening - Study advertisements will direct interested parents/legal guardians of children to an online screening (via QR code). The online screening survey will be administered by REDCap and completed on their device. The screener will also include a document with mental health and eating disorder referral information because the screening process may raise awareness of these concerns. Potentially eligible families will be contacted via email or phone to set up a time for the study visit at UTD.
Study visits - Participants will complete 3 annual data collection visits that will be 12 months apart (Year 1, 2, and 3). During Years 1-2, participants and parents/guardians will complete a virtual session with researchers followed by an in-person visit at the UTD Brain Health Imaging Center (BHIC) where participants will complete the neuroimaging (fMRI) protocol. The Year 3 study visit will take place at Dr. Smith's research laboratory in the UTD Department of Psychology. During scheduling of study visits involving fMRI (Years 1-2), families will also be informed that participants will be asked to abstain from eating for 4 hours prior to fMRI to standardize procedures and capture representative physiological states prior to eating meals (during which inhibitory control, emotion regulation, and reward processing may influence subsequent eating behavior). We will provide mental health and eating disorder referral information to all families at study visits because the assessment process may raise awareness of concerns the parent was not previously aware of.
Informed by published ethical guidance for pediatric research developed for the NIH-funded Adolescent Brain and Cognitive Development (ABCD) study, parents will not be shown their child's individual interview or survey responses, with two exceptions: (1) current suicidal ideation or self-harm, and (2) eating disorder symptoms indicating the child is at serious medical or psychiatric risk (e.g., significantly low weight/weight loss or dangerous compensatory behaviors such as frequent purging). This will be operationalized as evidence of:
- BMI percentile below the 5th percentile for age/sex
- Rapid and significant weight loss
- Self-report during the clinical interview indicating compensatory behaviors (self-induced vomiting, laxative/diuretic misuse, fasting, compulsive exercise) occurring several times per week For consistency, and to protect the validity of adolescent self-report, we align the threshold of disclosing eating disorders with the same imminent/serious-risk standard as outlined in the ABCD study.
Year 1:
Virtual session - At the first virtual session, parents/guardians and participants will complete the initial informed consent and assent process with researchers virtually. During the informed consent process and in the consent form, it will also be explained that participants may be ruled out after enrollment if they do not meet study eligibility criteria (e.g., based on information provided during the clinical interview or their height/weight) or if MRI is not appropriate for participants due to contraindications. Following the informed consent process, participants' eligibility will be confirmed based on a clinical interview (Child Eating Disorder Examination administered virtually) and anthropometric (height/weight/waist circumference) measurements at the in-person visit. During the virtual session, participants and parents/guardians will complete self-report surveys online and receive mobile phone and accelerometer instructions.
In-person visit (UTD Brain Health Imaging Center) - Participants will complete a neuroimaging protocol and anthropometric assessments at the UTD Brain Health Imaging Center (accompanied by their parent/guardian), which will be scheduled within 2 weeks of the virtual session.
10-day data collection - Over the next 10 days after the in-person visit, participants will proceed through a 10-day data collection period in their daily life. This includes an ecological momentary assessment (EMA) protocol during which participants will be asked to proceed with their daily routines as normal. Participants will also wear an accelerometer across all 10 days. Staff will contact families by phone during the 10-day monitoring period to encourage compliance and address technical issues.
Year 2:
Virtual session - The consent and assent process will be repeated. Participants will repeat the clinical interview, and participants and parents/guardians will complete online surveys.
In-person visit (UTD Brain Health Imaging Center) - Participants will repeat the neuroimaging protocol and anthropometric assessments at the UTD Brain Health Imaging Center (accompanied by their parent/guardian), which will be scheduled within 2 weeks of the virtual session.
10-day data collection - Participants will repeat the 10-day data collection period.
Year 3:
In-person visit (UTD Psychology Department) - The consent and assent process will be repeated. Participants will repeat the clinical interview, anthropometric assessments, and participants and parents/guardians will complete online surveys.
10-day data collection - Participants will repeat the 10-day data collection period.
Data collection measures will include the following:
Anthropometric assessment (Years 1-3) - At each in-person study visit, height, weight, and waist circumference of the participant will be measured in duplicate using an electronically calibrated digital scale and professional stadiometer to the nearest 0.1 kg and 0.1 cm, respectively. Blind weight will be measured (i.e., they will not see their weight) to mitigate any distress or reactivity. These measurements will be completed at the BHIC in Years 1-2, and in Dr. Smith's research laboratory during Year 3.
Interview (Years 1-3) - Each year, participants will complete a clinical interview 9Child Eating Disorder Examination [ChEDE] diagnostic modules). This interview will be administered virtually in Years 1-2 and in-person at UT Dallas in Year 3. The ChEDE will be used to confirm eligibility at Year 1 and for descriptive purposes in Years 2-3.
Self-report questionnaires (Years 1-3) - Participants will report on their gender identity and sexual orientation, and they will complete a series of self-report questionnaires online.
Neuroimaging (Years 1-2) - In Years 1 and 2, participants will complete an fMRI protocol at the BHIC.
Prior to fMRI participants will also complete online surveys that assess exercise over the previous 24 hours, as well as current hunger state (using a visual analog scale from 0 [not hungry at all] to 10 [very hungry]) that will be considered as covariates in analyses. Participants will be asked to confirm they have abstained from eating for 4 hours prior to MRI. Parent/guardians will be asked to confirm eating abstinence, and imaging will be done at the end of the study session (i.e., after interview/questionnaire assessments) to ensure children have not eaten recently.
After completing pre-scan measures, participants will complete a practice session in the MR (magnetic resonance) simulator to familiarize participants with the scanning environment. Then they will complete the MRI protocol which includes complete three tasks in a randomized order while brain activity is being recorded with fMRI. Tasks will be projected on a screen located at the rear of the magnet and viewed via a head coil mirror. A response keypad will record task responses. The neuroimaging protocol will first acquire T2, T1, field map, and scout scans (~8-10 min) then two runs of the go/no-go task (~5 min/run), two runs of the visual food task (~6 min/run), and four runs of the emotion regulation task (~4 min/run), totaling 46-48 minutes of scanning time. Participants may take breaks as needed between runs.
Ecological momentary assessment (EMA; Years 1-3) - Across the 3 years, participants will complete an annual 10-day EMA protocol in their natural environment using an EMA application for smartphones. Participants will use a smartphone (either their own or one provided) to complete surveys, up to 4 times during non-school time on weekdays (morning wake-up time; 3:30pm-8pm) and up to 7 times on weekend days (9am-9pm). EMA measures will be collected using (1) signal-contingent reporting, which requires youth to complete assessments occurring at various times throughout the day in response to semi-random prompts, and (2) event-contingent reporting, which requires youth complete a survey after they engage in an eating episode. Semi-random prompts will be generated in stratified random sampling windows, with one prompt randomly occurring during each window. Youth will not complete random surveys on weekdays while at school to prevent classroom interruptions. However, they will be asked to record lunch on weekdays at school. At each semi-random signal, participants will also be prompted to report any missed eating episodes. Participants will receive information and training in the completion of EMA reports and behavioral tasks on the smartphone. Participants will be instructed not to complete entries at times when they feel they are not able or when safety is a concern. However, participants will be encouraged to complete the entry as soon as possible when able and will receive reminder prompts. Up to two reminder prompts will be sent within 30 minutes of the initial prompt, after which time the survey will close. Staff will call participants and their caregivers halfway through the protocol to give compliance feedback and to answer questions.
Ambulatory assessment (Years 1-3) - Physical activity and sedentary time will be measured using wrist-worn accelerometers. Participants will wear accelerometers continuously across 10-day monitoring period each year. Activity counts will be recorded in 10-second epochs. Participants will be provided with an accelerometer at each of the in-person visits, and parents/guardians will be provided with a self-addressed prepaid package to return the device after the 10-day monitoring period.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Go/No-go task, Behavioral: Visual food task, Behavioral: Emotion regulation taskParticipants will be assigned all three behavioral tasks. |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Can read and speak English.
- At-risk for loss of control eating will be over-sampled (representing minimum 30% of sample) to capture sufficient variability across time in loss of control eating, the online screener will include the Eating Disorders Examination Questionnaire-Short Parent Version (EDE-QS-P). At-risk for loss of control eating is defined on the EDE-QS-P as a global score at least 1 standard deviation above the mean EDE-QS-P score observed among parents of children without eating disorders (i.e., global score > 1.2).
Key exclusion criteria (9 listed)
- Diagnosis of an eating disorder other than binge-eating disorder or subthreshold binge-eating disorder (i.e., binge-eating disorder of low frequency/limited duration), or presence of compulsive exercise as assessed by the Child Eating Disorder Examination.
- Health issues that limit physical activity.
- Intellectual disability (assessed with the Child and Adolescent Intellectual Disability Screening Questionnaire embedded within the online eligibility screener), which would interfere with completing ecological momentary assessment.
- Pregnancy.
- Acute suicidality (screened using item 9 on the Patient Health Questionnaire-Adolescent).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Go/No-go taskThis task will assess participants' general and food-related inhibitory control. Participants will be instructed to press a button to "go" cues and withhold responses to "no-go" cues. In one run, low caloric food images will be the "go" cues, and high caloric food images will be the "no-go" cues. In another run, images of school supplies will be the "go" cues, and toys will be the "no-go" cues. | Behavioural | Experimental |
| Visual food taskThis task will measure participants' food-related reward processing and food cue reactivity. Participants will view food and non-food images, and brain activity will be assessed while viewing images. | Behavioural | Experimental |
| Emotion regulation taskThis task will assess participants' ability to modulate negative affect in response to emotionally evocative images. Negative and neutral pictures will be selected from the IAPS database using criteria analogous to prior research. At the start of each trial, an instruction word will be presented ("decrease" or "look") for 4 sec, after which a picture will be presented for 8 sec. The pictures will be negative if the instruction is "decrease" (emotion regulation instruction), negative or neutral if the instruction is "look" (non-regulation). This is followed by a rating of negative affect ranging from 1="'weak" and 4="strong" (4 sec), and then the word "relax" (4 sec). The combinations of instruction and pictures yields 3 trial types: decrease negative (reappraisal), look negative (nonregulation) and look neutral (non-emotional). A total of 72 trials will be given (24 of each trial type) over 4 runs (~4 min/run). | Behavioural | Experimental |
Primary outcome
Inhibitory control
Time frame: Baseline during visit 1, and one year later at visit 2
The behavioral outcome will be unsuccessful inhibition during no-go trials (commission error rate; i.e., the number of failures of inhibition divided by the total number of no-go trial), calculated separately for food and non-food. Changes in brain activity (through fMRI) will also be examined. For each condition (i.e., food and non-food stimulus blocks), analyses will evaluate contrast of successful no-go versus implicit baseline (fixation cross) and successful no-go versus unsuccessful no-go trials. Percent change in BOLD response within priori regions of interest (ROIs) will be extracted from these contrasts and used in subsequent analyses. ROIs (based on prior research) will include the inferior frontal gyrus (IFG), ventromedial prefrontal cortex (vmPFC), dorsolateral prefrontal cortex (dlPFC), and ventrolateral prefrontal cortex (vlPFC), as defined by the Harvard-Oxford Cortical Structural Atlas.
Food-related reward processing
Time frame: Baseline during visit 1, and one year later at visit 2
The outcome measure will assess changes in brain activity, as measured by fMRI, during exposure to food and non-food images. A general linear model will include three regressors: high-calorie food stimuli, low-calorie food stimuli, and non-food stimuli. Analyses will examine contrasts comparing food stimuli (combined high-calorie and low-calorie food conditions) with non-food stimuli to evaluate differences in BOLD activation within a priori regions of interest (ROIs). Percent change in BOLD signal within these ROIs will be extracted and used in subsequent analyses. Based on prior meta-analytic findings, ROIs will include regions implicated in reward and motivation (amygdala, orbitofrontal cortex, nucleus accumbens, and dorsal striatum), homeostatic regulation (hypothalamus), inhibitory control (dorsolateral prefrontal cortex [dlPFC]), and gustatory processing (insula).
Emotion Processing
Time frame: Baseline during visit 1, and one year later at visit 2
The outcome measure will assess changes in brain activity, as measured by fMRI, across three task conditions: decrease negative (cognitive reappraisal), look negative (passive viewing of negative stimuli), and look neutral (passive viewing of neutral stimuli). Analyses will focus on the contrast between the decrease negative and look negative conditions to evaluate neural activity associated with emotion regulation. Percent change in the BOLD response within a priori regions of interest (ROIs) will be extracted from this contrast and used in subsequent analyses. A priori ROIs will include anatomically defined masks of the anterior cingulate cortex (ACC), medial prefrontal cortex (mPFC), ventrolateral prefrontal cortex (vlPFC), and dorsolateral prefrontal cortex (dlPFC), as defined by the Harvard-Oxford Cortical Structural Atlas.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Background: PubMed 28716389Clark DB, Fisher CB, Bookheimer S, Brown SA, Evans JH, Hopfer C, Hudziak J, Montoya I, Murray M, Pfefferbaum A, Yurgelun-Todd D. Biomedical ethics and clinical oversight in multisite observational neuroimaging studies with children and adolescents: The ABCD experience. Dev Cogn Neurosci. 2018 Aug;32:143-154. doi: 10.1016/j.dcn.2017.06.005. Epub 2017 Jun 28.
- Individual participant dataSharing planned: Yes. De-identified demographic, clinical, survey, ambulatory assessment, and fMRI imaging data.
Related trials for Binge Eating Behaviour
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Not yet recruiting
Cognitive and Behavioral Approaches to Reduce Binge Eating and Excess Weight in Adolescents (Online)
Binge Eating, Overweight and Obesity
RecruitingObservational study
Children s Growth and Behavior Study
Obesity, Eating Behaviors
Recruiting
Optimizing Digital Health Technology Interventions to Increase Skill Acquisition and Utilization
Bulimia Nervosa, Bulimia
Active, not recruiting
Mindful Motivation for Reducing Binge Eating
Binge Eating, Psychological
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Go/No-go task, Visual food task and Emotion regulation task in people with Binge Eating Behaviour and Eating Disorders, run by The University of Texas at Dallas at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inhibitory control (time frame: Baseline during visit 1, and one year later at visit 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07823153, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.