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临床试验/NCT03353649
NCT03353649已完成不适用

Applying Novel Technologies and Methods to Inform the Ontology of Self-Regulation: Binge Eating and Smoking

Stanford University2 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2017年12月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
115
试验地点
2
主要终点
Changes in fMRI functional connectivity

研究概览

简要总结

This study aims to examine targets of self-regulatory function among two exemplar populations for which behavior plays a critical role in health outcomes: smokers and individual who binge eat (BED). This is the second phase of a study that aims to identify putative mechanisms of behavior change to develop an overarching "ontology" of self-regulatory processes.

详细描述

Health risk behavior, including poor diet, physical inactivity, tobacco and other substance use, causes as much as 40% of the illness, suffering, and early death related to chronic diseases. Non-adherence to medical regimens is an important exemplar of the challenges in changing health risk behavior -- and is common, costly (due to increased utilization of healthcare services), and associated with poor patient outcomes. This may be particularly evident among older adults who experience a disproportionate amount of the chronic disease burden in the U.S. Although an array of interventions have been shown to be effective in promoting health behavior change, much of this work has been siloed (focused on one disorder at a time).

Additionally, interventions are typically intended to engage multiple mechanisms of behavior change, but the mechanisms by which they actually work are infrequently systematically examined. Because the need to alter health-related behavior is ubiquitous across medicine, understanding the extent to which the principles of effective health behavior change, and the mechanisms by which they work, are similar or differ across health conditions and settings is a critically important area of scientific inquiry. Improving medical regimen adherence and promoting health behavior change are also crucial issues in the changing healthcare landscape, where quality, value, cost and patient-centered care are central. This line of research may allow for great strides in crafting "precision medicine" approaches for a wide array of populations.

One promising domain of putative behavior change targets is that of self-regulation -- a person's ability to manage cognitive, motivational and emotional resources to act in accordance with his/her long-term goals. In this proposal, the investigators have assembled an outstanding interdisciplinary team to 'scale up' this work to an unprecedented level by examining putative targets of behavior change within the self-regulation mechanism domain across contexts, populations, and assays - in 3 primary levels of analysis: (1) psychological (e.g., constructs such as self-efficacy; emotion regulation; response inhibition), (2) behavioral (e.g., tasks of reward responsiveness; temporal horizon), and (3) biological (structural and functional MRI of key neural circuitry). The investigators will conduct this work with two exemplar populations for which behavior plays a critical role in the course of medical regimen adherence, health, and health outcomes: (1) smokers and (2) binge eaters.

In these groups, the investigators will evaluate the extent to which participants can engage and manipulate putative targets within the self-regulation domain both within and outside of laboratory settings. 50 smokers and 50 obese/overweight persons will participate in a lab study to complete the identified tasks.

The investigators will experimentally modulate engagement of targets (e.g., stimulus set of palatable foods images or tobacco-related images as well as self-regulation interventions).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Understand English sufficiently to provide informed consent
  • Right-handed
  • Normal or corrected-to-normal vision and no color blindness
  • Additional Inclusion Criteria for Smoking sample:
  • Smoke 5 or more tobacco cigarettes/day for past year
  • BMI greater than or equal to 17 and less than 27
  • Additional Inclusion Criteria for Binge Eating Sample:
  • BMI greater than or equal to 27 and less than 45
  • Weight limit of 350 lbs
  • Non-smoking (defined as no cigarettes in past 12 months-this includes former and never smokers)

排除标准

  • Significant medical illness
  • History of mental disorder due to a medical condition
  • Lifetime history of major psychotic disorders (including schizophrenia and bipolar disorder)
  • Current use of any medication for psychiatric reasons (including stimulants and mood stabilizers)
  • Additional Exclusion criteria for Binge Eating Sample:
  • Lost weight in recent past (>10 pounds in past 6 months)
  • Currently in a weight-loss program (e.g., Weight Watchers, Jenny Craig)
  • Currently on a special diet for a serious health condition
  • Additional Exclusion Criteria for Smoking Sample:
  • Binge eating behavior

研究组 & 干预措施

Binge Eating Group

Experimental

(1) exposing subjects to specific stimulus sets relevant to the sample that may promote engagement of appetitive drives (images of highly palatable foods for obese individuals), and (2) exposing them to an instructional manipulation designed to engage self-regulatory processes in the presence of these stimulus sets. Specifically, participants in this sample will be exposed to images of food and control non-food images. In different trials, subjects will be given a "now" cue instructing them to engage with the immediate hedonic properties of the stimulus or a "later" cue instructing them to imagine the long-term consequences of using the stimulus.

This arm includes fMRI and the now vs. later cue intervention

干预措施: Now vs. Later Cue (Behavioral)

Binge Eating Group

Experimental

(1) exposing subjects to specific stimulus sets relevant to the sample that may promote engagement of appetitive drives (images of highly palatable foods for obese individuals), and (2) exposing them to an instructional manipulation designed to engage self-regulatory processes in the presence of these stimulus sets. Specifically, participants in this sample will be exposed to images of food and control non-food images. In different trials, subjects will be given a "now" cue instructing them to engage with the immediate hedonic properties of the stimulus or a "later" cue instructing them to imagine the long-term consequences of using the stimulus.

This arm includes fMRI and the now vs. later cue intervention

干预措施: fMRI (Device)

Smoking Group

Experimental

(1) exposing subjects to specific stimulus sets relevant to the sample that may promote engagement of appetitive drives (tobacco-related images or smokers), and (2) exposing them to an instructional manipulation designed to engage self-regulatory processes in the presence of these stimulus sets.

A similar approach to the Binge Eating sample will be used for the smoking sample using two stimulus sets. Instead of foods and non-food control images, smokers will see smoking-related images and the same control non-food non-smoking images as the Binge Eating sample.

This Arm includes fMRI and the now vs. later cue intervention

干预措施: Now vs. Later Cue (Behavioral)

Smoking Group

Experimental

(1) exposing subjects to specific stimulus sets relevant to the sample that may promote engagement of appetitive drives (tobacco-related images or smokers), and (2) exposing them to an instructional manipulation designed to engage self-regulatory processes in the presence of these stimulus sets.

A similar approach to the Binge Eating sample will be used for the smoking sample using two stimulus sets. Instead of foods and non-food control images, smokers will see smoking-related images and the same control non-food non-smoking images as the Binge Eating sample.

This Arm includes fMRI and the now vs. later cue intervention

干预措施: fMRI (Device)

结局指标

主要结局

Changes in fMRI functional connectivity

时间窗: A single 1.5 hour session for each subject

Interaction of stimulus class, which is the stimulus of value (smoking stimuli for smokers and palatable foods for binge eaters) vs. neutral control stimuli, with the cue, which is the now vs. later cue. The fMRI functional connectivity changes relating to this interaction is taken as the connectivity-based neural underpinnings of self-regulation.

Behavioral Regulation

时间窗: A single 1.5 hour session for each subject

Interaction of stimulus class, which is the stimulus of value (smoking stimuli for smokers and palatable foods for binge eaters) vs. neutral control stimuli, with the cue, which is the now vs. later cue. The degree to which subjects can regulate their desire to consume their stimulus of value after a later cue is evidence of successful self regulation.

Regulation of fMRI activation

时间窗: A single 1.5 hour session for each subject

Interaction of stimulus class, which is the stimulus of value (smoking stimuli for smokers and palatable foods for binge eaters) vs. neutral control stimuli, with the cue, which is the now vs. later cue. The fMRI activation relating to this interaction is taken as the activation-based neural underpinnings of self-regulation.

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

Russell Alan Poldrack

Professor

Stanford University

研究点 (2)

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