Applying Novel Technologies and Methods to Inform the Ontology of Self-Regulation: Aim 4
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Binge Eating Episodes - Overeating
研究概览
简要总结
This study will evaluate the extent to which we can engage and manipulate putative targets within the self-regulation domain within and outside of laboratory settings in samples of smokers and overweight/obese individuals with binge eating disorder. This is the fourth phase of a study that aims to identify putative mechanisms of behavior change to develop an overarching "ontology" of self-regulatory processes.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Understand English sufficiently to provide informed consent
- •Right-handed
- •Normal or corrected-to-normal vision and no color blindness
- •Interest in engaging with Laddr to modify self-regulatory behavior
- •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
- •Current engagement in psychotherapy for binge eating disorder
- •Additional Exclusion Criteria for Smoking Sample:
- •Binge eating behavior
- •Current engagement in psychotherapy for smoking behavior
研究组 & 干预措施
Binge Eating Group
All participants in the study will be invited to use Laddr, described in the intervention section.
干预措施: Laddr (Behavioral)
Smoking Group
All participants in the study will be invited to use Laddr, described in the intervention section.
干预措施: Laddr (Behavioral)
结局指标
主要结局
Binge Eating Episodes - Overeating
时间窗: 28 days
Self-reported binge eating episodes is assessed four times daily (morning, early afternoon, late afternoon/evening, and night). A binge eating episode is defined as self-reported overeating and loss of control. Overeating is assessed by the question "Since the last prompt, when you ate most recently, did you overeat?" and is scored as 0 (no) or 1 (yes). Responses provided were averaged across the 28-day period.
Number of Cigarettes Smoked Per Day
时间窗: 28 days
Self-reported smoking assessed four times daily (morning, early afternoon, late afternoon/evening, and night). A smoking episode is defined as self-reported smoking of more than zero cigarettes and is assessed by the question "Since the last prompt, how many cigarettes have you smoked?" Participants are asked to input a number into a number field and this was averaged over the 28 day period.
Binge Eating Episodes - Loss of Control
时间窗: 28 days
Self-reported binge eating episodes is assessed four times daily (morning, early afternoon, late afternoon/evening, and night). A binge eating episode is defined as self-reported overeating and loss of control. Loss of control is assessed by the question "When you ate most recently, did you lose control over your eating?" and is scored as 0 (No), 1 (Yes). Responses provided were averaged across the 28-day period.
次要结局
未报告次要终点
研究者
Russell Alan Poldrack
Professor
Stanford University