Activity and Self-Regulation for Binge Eating Disorder in Children

Not yet recruiting at 2 trial locations
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas at Dallas
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Are You a Good Fit for This Trial?

This trial is for boys and girls aged 10-12 who may have issues with binge eating or other eating disorders. Participants will be followed for three years to study their physical activity, self-control, emotions, and eating behaviors.

Inclusion Criteria

Can read and speak English
At-risk for loss of control eating defined by EDE-QS-P global score > 1.2, representing minimum 30% of sample to capture variability

Exclusion Criteria

Conditions making fMRI unsafe (e.g., pacemaker)
Diagnosis of eating disorder other than binge-eating disorder or subthreshold binge-eating disorder, or presence of compulsive exercise
I have health problems that limit my physical activity.
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What Are the Treatments Tested in This Trial?

Interventions

  • Emotion regulation task
  • Go/No-go task
  • Visual food task

Trial Overview

Researchers are using tasks that measure attention, response to food images, and emotion control—along with brain scans and real-time tracking—to see how activity levels and self-regulation affect loss of control eating in children over time.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: ExperimentalExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas at Dallas

Lead Sponsor

Trials
71
Recruited
108,000+

George Mason University

Collaborator

Trials
60
Recruited
50,200+

University of Southern California

Collaborator

Trials
956
Recruited
1,609,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+