Biobehavioral Mechanisms of Activity and Loss of Control Eating in Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Inhibitory control
研究概览
简要总结
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).
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
- •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).
研究组 & 干预措施
Experimental
Participants will be assigned all three behavioral tasks.
干预措施: Go/No-go task (Behavioral)
Experimental
Participants will be assigned all three behavioral tasks.
干预措施: Visual food task (Behavioral)
Experimental
Participants will be assigned all three behavioral tasks.
干预措施: Emotion regulation task (Behavioral)
结局指标
主要结局
Inhibitory control
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Dr. Kathryn Smith
Assistant Professor
The University of Texas at Dallas