Time Restricted Eating for Weight Loss Maintenance (TWIST): A Single-Site, Pilot Feasibility and Acceptability Randomized Clinical Trial in Adults With Recent Weight Loss
概览
- 阶段
- 不适用
- 干预措施
- Time Restricted Eating (TRE)
- 疾病 / 适应症
- Obesity
- 发起方
- NYU Langone Health
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Recruitment Rate
- 状态
- 已完成
- 最后更新
- 2个月前
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.
研究者
入排标准
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
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)
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)
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).
次要结局
- Change from Baseline in Lean Mass(Baseline, Week 12)
- Change from Baseline in Fat Mass(Baseline, Week 12)