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临床试验/NCT02347527
NCT02347527已完成不适用

Neuronal and Behavioral Effects of Implicit Priming in Obese Individuals

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2013年5月1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
92
试验地点
1
主要终点
Change in Food Image Ratings

研究概览

简要总结

The overall goals of this project are to determine the impact of an implicit priming intervention, designed to alter food perceptions, on both brain responses to food and on food intake behaviors in overweight/obese individuals. The investigators hypothesized that this bottom-up sensory-level conditioning approach would effectively result in reduced preference for high-calorie foods.

详细描述

One factor that may contribute to susceptibility to obesity is a high responsivity to high-calorie foods in terms of cognitive factors such as emotional associations, reward value or reinforcing properties of food. Many of these processes involve learned associations thought to develop via classical conditioning through repeated pairings with external stimuli, which can influence food preferences and intake. As such, improving our understanding of the neuronal mechanisms underlying these processes and attempting to modify them may be a useful strategy to promote weight loss and maintenance. Therefore, the proposed study aims to investigate the effects of altering food perception on neuronal responses and food intake behaviors by using implicit priming, in which positively or negatively valenced images are presented immediately prior to food images, but are not consciously perceived.

The project goals are to determine the impact of the implicit priming intervention on both brain responses to food cues and on food intake behaviors in overweight/obese individuals. Food image ratings were assessed before and after either (a) an active implicit priming intervention or (b) a control intervention. One group of participants (n = 47; "MRI sample") completed the intervention during an fMRI scan and completed a visual food cues task both before and after the intervention (during fMRI), to assess intervention-related change in neuronal responses to food cues. In this group, food intake measures were also taken following fMRI. In a separate group of participants (n = 45; "Behavioral-only sample"), the primary outcome measure was the change in food image ratings from pre- to post-intervention; fMRI and measures of food intake were not assessed in this group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Overweight/obese adults
  • •Healthy weight adults

排除标准

  • •Vegetarian, vegan, or having other wide-ranging food restrictions
  • •Currently dieting
  • •MRI exclusion criteria, if in MRI sample (e.g., claustrophobia, metal in the body)

研究组 & 干预措施

Active Implicit Priming (MRI sample)

Experimental

Participants will complete active implicit priming, in which food images are implicitly primed (i.e., below conscious awareness) with images of positive or negative affect. In addition to measures of food image ratings, this group completed a visual food cues scan during fMRI to assess change in neuronal response to food cues. They also completed a measure of food intake post-intervention.

干预措施: Active Implicit Priming (Behavioral)

Control Implicit Priming (MRI sample)

Placebo Comparator

Participants will complete a control implicit priming intervention, which matches the active intervention, but with neutral stimuli as primes. In addition to measures of food image ratings, this group completed a visual food cues scan during fMRI to assess change in neuronal response to food cues. They also completed a measure of food intake post-intervention.

干预措施: Control Implicit Priming (Behavioral)

Active Implicit Priming (Behavioral-only sample)

Experimental

Participants will complete active implicit priming, in which food images are implicitly primed (i.e., below conscious awareness) with images of positive or negative affect.

干预措施: Active Implicit Priming (Behavioral)

Control Implicit Priming (Behavioral-only sample)

Placebo Comparator

Participants will complete a control implicit priming intervention, which matches the active intervention, but with neutral stimuli as primes.

干预措施: Control Implicit Priming (Behavioral)

结局指标

主要结局

Change in Food Image Ratings

时间窗: Baseline to within 10 minutes post-intervention

Food image ratings (high-calorie foods) change from baseline, measured within 10 minutes post-intervention. Food images are rated on "desire to eat" by visual analogue scale (0-100; higher scores mean greater desire to eat). Negative values indicate reduced scores post-intervention compared to baseline, with greater numbers indicating greater reduction.

Neuronal Response to Food Cues

时间窗: Baseline to post-intervention

Neuronal response while viewing visual food cues will be measured using functional magnetic resonance imaging (fMRI). Primary outcome was insula response change from baseline, as measured within 20 minutes after the intervention. A bilateral region of interest (ROI) for the insula was defined anatomically, with mean difference from baseline to post-intervention (% BOLD signal change) calculated across all voxels for that ROI. A positive number indicates a reduced response (with higher numbers indicating greater change) and a negative number indicates an increased response.

次要结局

  • Food Intake(1 hour post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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