NCT04871295已完成不适用
Randomized, Controlled Trial of a Weight Loss Intervention in Improving Quality of Life in Men and Women With Overweight or Obesity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Noom Inc.
- 入组人数
- 370
- 试验地点
- 2
- 主要终点
- In app engagement measures
研究概览
简要总结
The purpose of this study is to evaluate the effect of the Noom Healthy Weight Program, a digital behavior change weight loss intervention, on quality of life as measured both by self-report and objective measures, compared to a waitlist control condition.
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
- 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
- 是
入选标准
- •Able to understand and provide informed consent
- •18-65 years old
- •Self-report of good health (physical and mental)
- •Not diagnosed with diabetes
- •Overweight or obesity (BMI ≥ 25)
- •Able to meet our criteria of adherence to the program (at least 1 engagement per week on one of the following: logged exercise, logged meals, steps, weigh-ins, coach messages, read articles, and days with at least one weigh-in.)
- •For females
- •Not within the 6 months postpartum time frame
- •Not planning to become pregnant in the next 5 months.
排除标准
- •Inability or unwillingness of a participant to give written informed consent
- •Currently taking medication which affects sleep or heart rate (e.g., (i) central nervous system stimulants, (ii) respiratory medications, (iii) antihistamines, (iv) central acting hormones (e.g. corticosteroids, thyroid), (v) high-dose anticholinergics, (vi) and cannot be using the maximum recommended dose for antihypertensive medications or use of multiple antihypertensive medications)
- •Current diagnosed mental health condition (except mild anxious or depressive symptoms)
- •Current diagnosed sleep disorder or condition not related to obesity (e.g., narcolepsy)
- •Currently pregnant or ≤ 6 months postpartum
- •Currently participating in shift work and/or have travelled between time zones in the last month
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the quality of the data; E.g., evidence of an eating disorder, major chronic condition
结局指标
主要结局
In app engagement measures
时间窗: 4 months
Self reported and automatically recorded
Weight
时间窗: 4 months
Self Reported
Stress
时间窗: 4 months
Measured via heart rate variability; Data will be collected with a wearable tracking device (Oura Ring). Heart rate variability (HRV) measures the specific changes in time (or variability) between successive heart beats. The time between beats is measured in milliseconds (ms) and is called an "R-R interval" or "inter-beat interval (IBI).
次要结局
- Self Reported Perceived Stress(4 months)
- Sleep Quality(4 months)
- Sleep Impact(4 months)
- Sleep Score(4 months)
- Appetite and food craving(4 months)
- Reward-related eating(4 months)
- Perceived physical and mental health over time(4 months)
- Depression and anxiety(4 months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Study to Evaluate the Effects of a Weight Management Program on Body WeightBody WeightNCT04107155Supplement Formulators, Inc.54
已完成
不适用
A Weight Loss Trial for Emotional EatingObesityNCT02055391Temple University79
已完成
不适用
A Prospective Study Investigating the Effects of a Novel Weight Management ProgramOverweightNCT01875354Pharmanex141
已完成
不适用
A Weight Maintenance Program Promoting Fat Loss in Pregnancy in Women With ObesityGestational Weight GainObesityNCT04731688Pennington Biomedical Research Center100
已完成
不适用
Weight Watchers Online 2015OverweightBody WeightObesityNCT02417220The Miriam Hospital92