Time Restricted Eating for Weight Loss Maintenance (TWIST): A Single-Site, Pilot Feasibility and Acceptability Randomized Clinical Trial in Adults With Recent Weight Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Recruitment Rate
研究概览
简要总结
The aim of this pilot feasibility and acceptability, randomized clinical trial will be to examine the effects of two-time restricted eating (TRE) interventions on weight loss maintenance (WLM). This study will be conducted in 40 individuals with non-surgical weight loss of ≥5% initial body weight recruited from the NYU Langone Health Weight Management Program and NY-MOVE! Weight Management Clinic at the Manhattan VA. Measurements will occur at baseline, 4 and 12 weeks. Participants will be randomized with equal allocation to 2 groups: (1) TRE6 or (2) TRE10. The TRE6 will restrict their eating window to 6 hours per day and the TRE10 to 10 hours per day.
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
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥5% non-surgical weight loss from NYULH-WMP and NY-MOVE! Endocrinology Weight Management Clinic in the last 3 months
- •BMI between 20.5 - 45 m/kg2
- •between the ages 25 to 65 years old
- •own a smartphone or willing to use a smartphone if provided for self-monitoring
- •Eating window >12 h per day
- •<150 mins/wk of physical activity
- •log at least 2 meals into the smartphone app on ≥5 days
排除标准
- •<25 years or >65 years of age
- •Body weight in excess of 400lbs (181.4kg)
- •pregnant, trying to get pregnant or breastfeeding
- •previous or planned bariatric surgery
- •previous or current history of eating disorder
- •ongoing participation in another weight-management research study
- •continued participation in a weight loss program other than the proposed study
- •currently on appetite suppressants
- •currently following intermittent fasting or skipping meals
- •eating window <11h 59min/day
- •perform overnight shift work more than once a week
- •work that includes travel across one or more time zones
- •currently on anti-obesity medications (AOMs) such as, GLP-1 analogues (exenatide, tirzepatide, semaglutide, liraglutide) and pancreatic lipase inhibitors (Orlistat/Xenical and Alli)
- •prescribed medications expected to result in weight loss such as Orlistat, Naltrexone, Bupropion, Lorcaserin, Phentermine, Topiramate, or Liraglutide, and who are unwilling to delay treatment with these medications for the next 3 months
- •unable or unwilling to provide informed consent
- •unable to participate meaningfully in the intervention (e.g., uncorrected sight and hearing impairment)
- •unwilling to accept randomization assignment
- •unable to log at least 2 meals into the smartphone app on ≥5 d during the screening period
- •have type 1 or other conditions that would preclude restricted eating windows
- •have type 2 diabetes with a HbA1c >7.0% on medications except for metformin alone
- •narcolepsy
- •active cancer
- •organ dysfunction
- •current steroid use
- •daytime sleepiness with the Epworth Sleepiness Scale >10
- •severe insomnia with a score ≥15 on the Insomnia Severity Index
- •>2.5 kg additional weight loss during run-in phase (weight regain is not an exclusion criteria)
研究组 & 干预措施
Time-Restricted Eating - 6 Hours (TRE6)
Participants will be instructed to consume all daily food and beverages during their allotted 6-hour time period.
干预措施: Time Restricted Eating (TRE) (Behavioral)
Time-Restricted Eating - 10 Hours (TRE10)
Participants will be instructed to consume all daily food and beverages during their allotted 10-hour time period.
干预措施: Time Restricted Eating (TRE) (Behavioral)
结局指标
主要结局
Recruitment Rate
时间窗: Up to Week 12
Number of individuals who must be approached to enroll one participant in the study. A recruitment funnel will be developed by documenting the total number of eligible patients completing the NYU Langone Health-WMP and NY- MOVE! programs losing ≥5% of their baseline body weight.
Adherence Rate
时间窗: Up to Week 12
Using data from participant-worn ActiGraphs and on eating patterns, a day will be labeled "adherent" if all eating occasions (food or beverage with caloric value) are measured inside (± 30 minutes) their prescribed eating window. Adherence rate will be calculated by dividing the total number of adherent days by the total number of days with a logged eating occasion.
Retention Rate
时间窗: Up to Week 12
Percentage of participants who complete all study visits. Measure of feasibility.
TRE Experience Questionnaire (TRE-EQ) Score
时间窗: Week 12
Online questionnaire that includes 5-point scaled items (0=strongly disagree, 5=strongly agree) regarding difficulties encountered with hunger and appetite; eating within the assigned window; coordinating the TRE window with work, school and home demands; and accommodating social connections (e.g., behaviors and preferences of fellow diners).
Change in TRE Experience Questionnaire (TRE-EQ) Score
时间窗: Week 4, Week 12
Online questionnaire that includes 5-point scaled items (0=strongly disagree, 5=strongly agree) regarding difficulties encountered with hunger and appetite; eating within the assigned window; coordinating the TRE window with work, school and home demands; and accommodating social connections (e.g., behaviors and preferences of fellow diners). The total score is the average of responses and ranges from 0-5; higher scores indicate greater difficulties.
次要结局
- Change from Baseline in Lean Mass(Baseline, Week 12)
- Change from Baseline in Fat Mass(Baseline, Week 12)
- Change From Baseline in Lean Mass(Baseline, Week 12)
- Change From Baseline in Fat Mass(Baseline, Week 12)