Biobehavioral Mechanisms of Activity and Loss of Control Eating in Children
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- The University of Texas at Dallas
- Study ID
- NCT07823153
- Status
- Not Yet Recruiting
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Conditions
- Binge Eating Behaviour
- Eating Disorders
- Ecological Momentary Assessment
- Functional Magnetic Resonance Imaging (fMRI)
- Loss of Control Eating
- Physical Activity
Eligibility Criteria
- Sex
- ALL
- Age
- 10 Years - 12 Years
- Healthy Volunteers
- Accepted
Interventions
- Go/No-go task — BEHAVIORALThis 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 task — BEHAVIORALThis 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 task — BEHAVIORALThis 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 Details
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).
Key Dates
- First listed
- Sep 16, 2026
- Start date
- Jan 15, 2027
- Status verified
- Sep 2026
- Primary completion
- Sep 1, 2030
- Completion
- Sep 1, 2030
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: ExperimentalParticipants will be assigned all three behavioral tasks.
Primary Outcome Measure
Inhibitory control [ Time Frame: Baseline during visit 1, and one year later at visit 2 ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90089 | |
| University of Texas at Dallas | Richardson | Texas | 75080 | |
| George Mason University | Fairfax | Virginia | 22030 |
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