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Think FAST Research Study

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ClinicalTrials.gov Identifier: NCT04938778
Recruitment Status : Recruiting
First Posted : June 24, 2021
Last Update Posted : June 29, 2021
Sponsor:
Information provided by (Responsible Party):
Darith James, Arizona State University

Tracking Information
First Submitted Date  ICMJE March 10, 2021
First Posted Date  ICMJE June 24, 2021
Last Update Posted Date June 29, 2021
Actual Study Start Date  ICMJE February 1, 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2021)
Memory and Attention Phone Screener (MAPS) [ Time Frame: 8 weeks ]
Cognitive Function and Performance Test.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2021)
  • Rapid Eating Assessment for Participants Scale (REAPS) [ Time Frame: 8 weeks ]
    Scale to asses eating behaviors. The scale has a minimum of 13 and a maximum of 39. Higher scores indicate higher diet quality.
  • Insomnia Severity Index (ISI) [ Time Frame: 8 weeks ]
    Scale to asses insomnia symptoms. The scale has a minimum of zero and maximum of 28 where zero would be absence of insomnia and 28 would be severe insomnia.
  • Mindful Eating Scale (MES) [ Time Frame: 8 weeks ]
    Scale to asses behaviors related to mindful eating. Each item has a minimum of zero and a maximum of 4 where 4 means less eating awareness.
  • Creature of Habit Scale (COHS) [ Time Frame: 8 weeks ]
    Scale to asses routine habits. Each item has a minimum of zero and a maximum of 4 where 4 means a more habitual nature.
  • Salivary Cortisol [ Time Frame: 8 weeks ]
    Measure of cortisol via participant saliva samples.
  • Body Mass Index (BMI) [ Time Frame: 8 weeks ]
    Self-reported body measurements .
Original Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2021)
  • Rapid Assessment of Participants Scale (REAPS) [ Time Frame: 8 weeks ]
    Scale to asses eating behaviors.
  • Insomnia Severity Index (ISI) [ Time Frame: 8 weeks ]
    Scale to asses insomnia symptoms.
  • Mindful Eating Scale (MES) [ Time Frame: 8 weeks ]
    Scale to asses behaviors related to mindful eating.
  • Creature of Habit Scale (COHS) [ Time Frame: 8 weeks ]
    Scale to asses routine habits.
  • Salivary Cortisol [ Time Frame: 8 weeks ]
    Measure of cortisol via participant saliva samples.
  • Body Mass Index (BMI) [ Time Frame: 8 weeks ]
    Self-reported body measurements .
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Think FAST Research Study
Official Title  ICMJE Prolonged Nightly Fasting (PNF) in Older Adults With Age-related Cognitive Decline: A Pilot Study Exploring Changes in Neurocognitive Function (Public Name:Think FAST)
Brief Summary To test a 14-hour prolonged nightly fasting (PNF) protocol in a group of older adults (≥ 65 years old) with self-identified age-related cognitive decline (ARCD) on the primary outcome of neurocognitive function and performance as measured by objective outcomes. The investigators will use an 8-week single group pre-post pilot study design to measure outcomes related to neurocognitive function and performance and cardiometabolic risk factors (i.e., sleep disturbances, body mass index).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Age-related Cognitive Decline
Intervention  ICMJE Other: PNF
PNF Participants will engage in 8 weeks of 14 hours per night fasting
Study Arms  ICMJE Experimental: Intervention Arm
8 week 14 hour prolonged nightly fasting intervention.
Intervention: Other: PNF
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 16, 2021)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 65 or older
  • Self-identified age-related cognitive decline (ARCD)
  • Has a text capable phone and access to wifi

Exclusion Criteria:

  • Diagnosed with an eating disorder in the past 20 years
  • Works a night shift
  • Cannot participate in a 14 hour fast
  • Has diabetes
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dara James, PhD 207-479-1440 dara.james@asu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04938778
Other Study ID Numbers  ICMJE 00012888
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Darith James, Arizona State University
Study Sponsor  ICMJE Arizona State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Arizona State University
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP