Time Restricted EATing (TREAT) Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Percentage of participants logging
研究概览
简要总结
The TREAT Pilot is a 3 months open-label pilot study to examine the effect of restricting the duration of eating (Time Restricted EATing) in metabolically unhealthy adults with overweight or obesity. This pilot study will allow the investigator to collect preliminary data for the design of a larger study.
详细描述
Disruption of the circadian rhythm, caused by aging, obesity, shift work, or prolonged daily eating duration into hours normally reserved for sleep, is a recognized risk factor for impaired metabolism and cardiovascular disease risk. Mice with disrupted clock gene have dysmetabolism. Restricting the eating window in these mice improves their metabolism.
Data will be collected to examine the feasibility and effect of a lifestyle intervention, aiming to reduce body weight in metabolically unhealthy individuals with overweight and obesity. The TREAT pilot study employs the use of mobile application to document eating behavior, when, what and how much people eat. In addition, the participants will receive reminders and complete in-person study visits to monitor their eating and sleeping schedule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 73 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: 45-73y old
- •overweight or obesity with BMI ≥25.0 and ≤35.0 kg/m2
- •pre-diabetes or diabetes only diet controlled (HbA1c <7%)
- •elevated Blood Pressure (BP) 120-129/<80 mmHg or stage 1 high BP 130-139/80-89 mmHg, with clinical Atherosclerotic Cardiovascular Disease (ASCVD) or estimated 10-y Cardiovascular Disease (CVD) risk <10%
- •having LDL cholesterol <150mg/dl
- •no known sleep, psychiatric or food intake disorders
- •in possession of a smart phone
- •English-speaking
- •must live in New York city geographical area and not have planned travel schedule interfering with the study
排除标准
- •history or clinical evidence of condition that affect sleep
- •significant organ system dysfunction/disease: diabetes, severe pulmonary, kidney or cardiovascular disease, and any evidence of active illness (e.g., fever)
- •history of seizure disorder
- •being on medications for diabetes, hypertension or dyslipidemia
- •previous bariatric surgery
- •history or current significant psychiatric disorder
- •use dietary supplements and/or medications known to affect sleep, circadian rhythms or metabolic function
- •smoking tobacco or using illegal or recreational drugs
- •consume excessive alcohol (women: >14 drinks/wk; men: >21 drinks/wk)
- •consume large amounts of caffeine daily (>2 cups of coffee or 8 oz caffeinated drinks per day)
- •participate in intense exercise (causing heavy breathing and sweating, such as jogging) >2 d/wk for ≥35 min or moderate exercise (e.g., brisk walking) for >150 min/wk
- •shift work
- •extreme early and late chronotypes
- •unwilling/unable to provide informed consent
研究组 & 干预措施
TREAT pilot study
Metabolically unhealthy overweight or obese potential participants who pass an in-person screen will enroll in a 2-week run-in period when they will use the app, to assess meal patterns under habitual living conditions.
干预措施: TREAT pilot intervention (Behavioral)
结局指标
主要结局
Percentage of participants logging
时间窗: 3 months
To measure the usage of app by recording the total number of days the participants logged in during study. Reported in percentage from 0 to 100% of time in use.
Percentage of patients who reduced eating duration by 4 hours
时间窗: 3 months
Change in eating duration from pre- to post-intervention will be calculated in from data collected in hours spent eating
次要结局
- % weight loss achieved post-intervention(Baseline to 3 months)
- % of participants who achieve ≥ 5% weight loss(Baseline to 3 months)
- Average time in duration of overnight fasting(3 months)
- Average time in sleep duration(3 months)
- Adherence to using the app(3 months)
研究者
Blandine Laferrere
Professor of Medicine
Columbia University