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临床试验/NCT05388318
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

Arizona State University2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2022年3月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
49
试验地点
2
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

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

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

申办方类型
Other
责任方
Sponsor

研究点 (2)

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