Using Continuous Glucose Monitoring to Detect and Intervene on Maintenance Factors for Trans-diagnostic Binge Eating Pathology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of weekly episodes of going ≥ 4 waking hours without eating
研究概览
简要总结
The current study will be one of the first to develop and test a passive data collection technique to detect both meal consumption and disordered eating symptoms in patients with clinically significant binge eating and the first just-in-time adaptive interventions (JITAIs) systems using passive sensing technology for eating pathology to be empirically evaluated. A small iterative open clinical trial using an ABAB design (A= SenseSupport Off, B=SenseSupport On) will be conducted to test the feasibility, acceptability, and target engagement of SenseSupport when paired with a 12 week in-person CBT treatment program. The hypothesis that larger decreases in dietary restriction will be observed during SenseSupport On phases compared to SenseSupport Off phases will be tested in this clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •Are 18 to 65 years old
- •Experience clinically significant binge eating (defined as 12 or more objectively large binge eating episodes in the past 3 months)
- •Engage in clinically significant dietary restriction (define as >1 standard deviation above community norms on the Eating Disorder Examination Dietary Restraint Subscale)
- •Have a BMI above 18.5
- •Are able to give consent
排除标准
- •Are unable to fluently speak, write and read English
- •Are receiving treatment for an eating disorder
- •Require immediate treatment for medical complications as a result of eating disorder symptoms
- •Have a mental handicap, or are experiencing other severe psychopathology that would limit the participants' ability to comply with the demands of the current study (e.g. severe depression with suicidal intent, active psychotic disorder)
- •Have diabetes
- •Are pregnant or planning to become pregnant within the next year
结局指标
主要结局
Number of weekly episodes of going ≥ 4 waking hours without eating
时间窗: 12 weeks
The number of weekly episodes of going ≥ 4 waking hours without eating captured through CGM and EMA data as well as an EDE-Q assessment before each weekly therapy session. Higher numbers indicate more weekly episodes of dietary restriction. There are no subscale scores or a total score. The number of weekly episodes of going ≥ 4 waking hours without eating will be used to assess the amount of dietary restriction occurring throughout the course of treatment as compared to baseline dietary restriction for the participant.
次要结局
- Technology Acceptance Model Scale (TAMS)(Assessed at weekly treatment sessions throughout treatment duration (12 weeks))
- Feedback Questionnaire (FQ)(Assessed at weekly treatment sessions throughout treatment duration (12 weeks))
- Eating Disorder Examination Questionnaire (EDE-Q)(Assessed before each weekly treatment session throughout treatment duration (12 weeks))