NCT05388318已完成不适用
Weight Reduction and Cognitive Health: A Remote Randomized Controlled Pilot Study Testing a Prolonged Nightly Fasting Intervention Among Obese, Stressed Mid-life Adults
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Telephone Montreal Cognitive Assessment
研究概览
简要总结
Using a randomized controlled trial (RCT) design, we will test feasibility and outcomes following an remotely delivered, nationwide 8-week prolonged nightly fasting (PNF) intervention compared to an health education control (HEC) in 50 obese, stressed mid-life adults to explore outcomes related to cognitive function, metabolism and associated lifestyle behaviors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •40-59 years old
- •experiencing memory loss
- •BMI 30-45.9
- •PSS-4 score ≥5
- •access to smartphone, zoom, and wifi
- •lives in United States
排除标准
- •pregnant,
- •neurological disorder
- •eating disorder within last 20 years
- •In current weight loss program
- •previously had bariatric surgery
- •works a night shit
- •health condition not conducive to nightly fasting
研究组 & 干预措施
Prolonged nightly fasting (PNF)
Experimental
干预措施: Prolonged nightly fasting (Behavioral)
Health Education Control (HEC)
Active Comparator
干预措施: Health Education Control (Behavioral)
结局指标
主要结局
Telephone Montreal Cognitive Assessment
时间窗: 8 weeks
T-MoCA, a measure of cognitive function
Every Day Cognition-12
时间窗: 8 weeks
ECOG-12, a measure of cognitive function
次要结局
- Creature of Habit Scale(8 weeks)
- Perceived Stress Scale- 10(8 weeks)
- Rapid Eating Assessment for Participants(8 weeks)
- Three-Factor Eating Questionnaire-Revised(8 weeks)
- Pittsburgh Sleep Quality Index(8 weeks)
研究者
研究点 (1)
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