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临床试验/NCT05107908
NCT05107908招募中不适用

Neuronal and Behavioral Effects of an Implicit Priming Approach to Improve Eating Behaviors in Obesity

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2021年11月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
228
试验地点
1
主要终点
Percent Change in Blood Oxygen Level Dependent (BOLD) Response to Visual Food Cues as Measured by Functional Magnetic Resonance Imaging

研究概览

简要总结

The purpose of this study is to determine how different behavioral interventions designed to alter food perceptions and behaviors affect brain responses to food, eating behaviors, and body weight.

研究设计

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

入排标准

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

入选标准

  • 18-65 years old
  • BMI of 27 or greater

排除标准

  • MRI contraindications (e.g., metal or electronic devices in the body)
  • Pregnancy

研究组 & 干预措施

Active Implicit Priming

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. This will be completed on a weekly basis for 12 weeks, for approximately 10 minutes each time.

干预措施: Active Implicit Priming (Behavioral)

Control Implicit Priming

Placebo Comparator

Participants will complete control implicit priming, which matches the active intervention, but with neutral stimuli as primes. This will be completed on a weekly basis for 12 weeks, for approximately 10 minutes each time.

干预措施: Control Implicit Priming (Behavioral)

Food Exposure Task

Active Comparator

Participants will complete a Food Exposure Task, in which they will be asked to smell, feel, lick, and imagine eating food items, but without actually eating them. This will be completed on a weekly basis for 12 weeks, for approximately 10-30 minutes each time.

干预措施: Food Exposure Task (Behavioral)

结局指标

主要结局

Percent Change in Blood Oxygen Level Dependent (BOLD) Response to Visual Food Cues as Measured by Functional Magnetic Resonance Imaging

时间窗: Baseline, 12 weeks

Percent change in blood oxygen level dependent (BOLD) response from baseline to after the 12-week intervention while viewing visual food cues will be measured using functional magnetic resonance imaging (fMRI), focusing on insula, striatum, and prefrontal cortex.

Change in Food Image Ratings

时间窗: Baseline, 12 weeks

Food image ratings change from baseline to after the 12-week intervention. Food images are rated on "desire to eat" by visual analogue scale (0-100), with higher scores indicating greater desire to eat.

Change in Food Intake

时间窗: Baseline, 12 weeks

Food intake change from baseline to after the 12-week intervention. Food intake will be measured as total calories consumed during an ad libitum meal.

次要结局

  • Percent Change in Body Weight(Baseline, 12 weeks)
  • Change in Fat Mass(Baseline, 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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