Evaluation of Brain Activity Changes After a Behavior Change Weight Loss Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Noom Inc.
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Flanker task performance: Intervention vs control
研究概览
简要总结
The aim of this study is to compare brain changes in individuals with overweight or obesity enrolled in either the Noom Healthy Weight program or a matched control. The study objectives (primary and secondary) are to measure brain change reported as ERP and EEG data over a 16-week timeframe. Additionally, we will explore changes in the default mode network (resting-state asymmetry in EEG measurements), changes in executive functioning, quality of life, mood, and salivary markers as they relate to EEG data.
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, Investigator)
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
- •Each subject must be able to understand and provide informed consent
- •Between the ages 18-60 years
- •Self-report of good health
- •Overweight or obesity (BMI ≥ 25)
- •Able to meet our criteria of adherence to the program
- •Able to attend in-person visit in Long Island, NY
排除标准
- •Inability or unwillingness to give written informed consent or comply with the study
- •Visual impairment that cannot be corrected with glasses or contact lenses
- •Any indication of drug, alcohol or medicine abuse.
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
- •Presence of a brain injury, psychiatric disorders, seizure disorders, and other neurological conditions
- •Reported eating disorder
- •Currently pregnant or 6 months postpartum
- •Planning to become pregnant within the next 5 months
研究组 & 干预措施
Control
Matched control group (Noom-branded 'healthy eating' short guide on weight loss).
干预措施: Matched Control (Other)
Noom Health Weight Program
干预措施: Noom Healthy Weight; mobile behavior change program for weight loss. (Behavioral)
结局指标
主要结局
Change in Flanker task performance: Intervention vs control
时间窗: 16 weeks
Change in amplitude and latency in conflict monitoring stage at 16 weeks
Change in behavioral inhibition
时间窗: 16 weeks
Change from baseline Flanker task performance at 16 weeks
次要结局
- Within-subject comparison for EEG data(16-week)
- Change in EEG data: Successful intervention (5% weight loss) in higher engagement subgroup (successful program completers) vs control(16-week)
- Comparison of EEG data in program starters to successful program completers(16-week)
研究者
Dr. Andreas Michaelides
Chief of Psychology
Noom Inc.