Biobehavioral Mechanisms of Activity and Loss of Control Eating in Children

NCT07823153 | Not Yet Recruiting

• 4 other identifiers: IRB-26-4721R01MH142463-01UP-26-00531STUDY00001354
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief 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. 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).

Conditions

Eating Disorders; Physical Activity; Binge Eating Behaviour; 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

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

  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.

  Baseline during visit 1, and one year later at visit 2

Study Arms (1)

Experimental

EXPERIMENTAL

Participants will be assigned all three behavioral tasks.

Behavioral: Go/No-go task; Behavioral: Visual food task; Behavioral: Emotion regulation task

Interventions

Go/No-go task BEHAVIORAL

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.

Experimental

Visual food task BEHAVIORAL

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.

Experimental

Emotion regulation task BEHAVIORAL

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).

Experimental

Eligibility Criteria

• Age: 10 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• The University of Texas at Dallas: lead
• George Mason University: collaborator
• University of Southern California: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

University of Southern California

Los Angeles, California, 90089, United States

Location

University of Texas at Dallas

Richardson, Texas, 75080, United States

Location

George Mason University

Fairfax, Virginia, 22030, United States

Location

Related Publications (1)

• 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.

  PMID: 28716389 BACKGROUND

MeSH Terms

Conditions

Binge-Eating Disorder; Feeding and Eating Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 16, 2026
• Study Start (Estimated): January 15, 2027
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: Starting when the award ends with no end date.

Locations

US (3)