Connectome-based Neurofeedback of the Craving Network to Reduce Food Cue Reactivity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool Healthy Eating Index (HEI).
研究概览
简要总结
This project tests whether individuals with overweight or obesity and high craving can learn to change their brain response to food cues using neurofeedback, to impact their craving and eating behavior.
详细描述
Aim 1 of this study is to test whether neurofeedback from the craving network is associated with reduced craving network strength.
Aim 2 of this study is to test whether neurofeedback from the craving network is associated with reduced food craving and changes in eating behavior.
Aim 3 of this study is to test whether neurofeedback from the craving network is associated with changes in resting state functional connectivity.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 18 to 60 years
- •Body mass index >25 kg/m2
- •>2.37 Food Craving Inventory score
排除标准
- •Current or past 6 months use of anti-obesity medications
- •Weight-reduced state defined as >10% weight reduction in the past 6 months.
- •Nicotine use
- •Current diagnosis of neurological or psychiatric disorder
- •Obesity-related diseases such as type-2 diabetes
- •Contraindications to MRI
- •Baseline scanning with motion >0.15mm frame to frame displacement.
结局指标
主要结局
Change in Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool Healthy Eating Index (HEI).
时间窗: Week 1, Week 7
ASA-24 HEI is scored 0-100 with 100 indicating healthier diet and composite scores examined to interpret the overall score. HEI will be compared between baseline and 1 month follow-up.
Change in Food Rating Task healthiness, tastiness, and choice scores
时间窗: Week 1, Week 7
Food Rating Task outcomes include healthiness, tastiness, and choice. Healthiness and tastiness mean score is taken, range 1-5, with 5 indicating higher healthiness or tastiness. Choice is counted from 0-48 items choosing the food item over the neutral reference food item, with higher values indicating more frequent choice. Food Ratings will be compared between baseline and 1 month follow-up.
Change in Food Snack Task caloric intake
时间窗: Week 1 and 3
Food Snack Task will be used to measure caloric intake (out of a maximum value to calories offered) and compared across scan sessions.
Change in craving network strength during transfer runs
时间窗: Week 1 and 3
Craving network strength will be measured during transfer (i.e., no feedback) runs and compared across scan sessions.
Change in Food Craving Inventory Mean Score
时间窗: Week 1, Week 7
Food Craving Inventory has 28 items rated 1-5 and overall mean is calculated, range 1-5 with higher score indicating higher craving. FCI will be compared between baseline and 1 month follow-up.
Change in craving network strength during resting state runs
时间窗: Week 1 and 3
Craving network strength will be measured during resting state runs and compared across scan sessions.
次要结局
未报告次要终点