跳至主要内容
临床试验/NCT04701671
NCT04701671进行中(未招募)不适用

Executive Functioning, Weight Trajectories, and Loss of Control Eating in Children With Overweight/Obesity: A Prospective Study

University of Pittsburgh4 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2020年12月10日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
180
试验地点
4
主要终点
BMI (Body Mass Index)

研究概览

简要总结

Overweight/obesity and loss of control eating (characterized by the sense that one cannot control what or how much one is eating) are prevalent among children and adolescents, and both are associated with serious medical and psychosocial health complications. Although our recently published data suggest that youth with these conditions may have relative deficits in neurocognitive functioning, particularly working memory, understanding of how these processes and their neural correlates are related to change and stability in eating and weight-related outcomes over time is limited, thereby impeding development of targeted, optimally timed interventions. The present study aims to assess prospective associations between general and food-specific executive functioning and underlying neural substrates, and eating and weight outcomes among children at varying levels of risk overweight/obesity and eating disorders, which will help guide research efforts towards the development of effective prevention and intervention strategies.

详细描述

The current study will examine prospective associations among general and food-specific EF and related neural substrates, and the developmental course of weight gain and LOC eating from middle childhood through early adolescence. Specific aims are to:

  1. Investigate prospective associations between general and food-specific EF and z-BMI trajectories. We expect that across risk groups, a) poorer baseline performance on both general and food-specific behavioral EF measures will predict steeper z-BMI gain trajectories; and b) worsening general and food-specific EF will track with the steepest z-BMI gain trajectories.
  2. Investigate associations between general and food-specific EF and LOC eating trajectories. We expect that across risk groups, a) poorer baseline performance on general and food-specific behavioral EF measures will predict worsening course of LOC eating; and b) worsening general and food-specific EF will track with worsening course of LOC eating.
  3. Investigate prospective associations between EF neural substrates and trajectories of z-BMI and LOC eating. We expect that across risk groups, a) greater activation in prefrontal regions associated with EF (e.g., dorsolateral prefrontal cortex, dorsal cingulate, parietal cortex) during general and food-specific WM tasks, and b) smaller decreases in activation of these regions over 18 months, will predict steeper z-BMI gain trajectories and worsening course of LOC eating.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
9 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Not currently taking any medications known to affect weight or appetite
  • Free of any current or past medical or psychiatric conditions known to significantly affect eating or weight (e.g., diabetes, bulimia nervosa), with the exception of binge eating disorder
  • In the low average range or higher on measures of general intellectual functioning
  • Free of any conditions affecting executive functioning (e.g., recent concussion, history of traumatic brain injury)
  • Fluent in English, and able to read and comprehend study materials
  • Not currently pregnant

排除标准

  • 未提供

结局指标

主要结局

BMI (Body Mass Index)

时间窗: Change in BMI from baseline to 24 months

BMI will be assessed using height and weight (cm/g)

Eating Behavior

时间窗: Change in eating behavior from baseline to 24 months

Eating behavior will be assessed using the Eating Disorder Examination (EDE), a semi-structured interview. Global scores are calculated, with higher scores indicating higher disordered eating symptomology.

General Executive Functioning

时间窗: Change in general executive functioning from baseline to 24 months

A general n-back task that will involve continuous presentation of neutral stimuli (letters or numbers). Participants indicate via button press whether the target (current) stimulus was presented n items ago.

Food-Specific Executive Functioning

时间窗: Change in food-specific executive functioning from baseline to 24 months

A food-specific WM task that involves continuous presentation of stimuli representing food and non-food items. Participants indicate via button press whether the target (current) stimulus was presented n items ago.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Goldschmidt

Associate Professor

University of Pittsburgh

研究点 (4)

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