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GetSmart: Weight Reduction and Cognitive Health: Pilot Study Testing a Prolonged Testing Prolonged Fasting Among Obese, Stressed Mid-life Adults

Sponsor
Arizona State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05388318
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
6.5
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Prolonged nightly fasting
  • Behavioral: Health Education Control
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trial with 2 groups (intervention and control).Randomized controlled trial with 2 groups (intervention and control).
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Weight Reduction and Cognitive Health: A Remote Randomized Controlled Pilot Study Testing a Prolonged Nightly Fasting Intervention Among Obese, Stressed Mid-life Adults
Actual Study Start Date :
Mar 17, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Prolonged nightly fasting (PNF)

Behavioral: Prolonged nightly fasting
14 hour nightly fast from caloric food and beverage; followed by 10 hour eating window. 8-week intervention duration.
Active Comparator: Health Education Control (HEC)

Behavioral: Health Education Control
Weekly health education video viewing related to general health topics

Outcome Measures

Primary Outcome Measures

  1. Telephone Montreal Cognitive Assessment [8 weeks]

    T-MoCA, a measure of cognitive function

  2. Every Day Cognition-12 [8 weeks]

    ECOG-12, a measure of cognitive function

Secondary Outcome Measures

  1. Perceived Stress Scale- 10 [8 weeks]

    PSS-10, a measure of perceived stress

  2. Rapid Eating Assessment for Participants [8 weeks]

    REAPS, a measure of eating behaviors

  3. Creature of Habit Scale [8 weeks]

    COHS, a measure of habitual behavior

  4. Three-Factor Eating Questionnaire-Revised [8 weeks]

    TFEQ, a measure of eating behaviors

  5. Pittsburgh Sleep Quality Index [8 weeks]

    PSQI, a measure of sleep quality

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 59 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • 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

Exclusion Criteria:

  • diabetes

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Arizona State University Phoenix Arizona United States 85004

Sponsors and Collaborators

  • Arizona State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Arizona State University
ClinicalTrials.gov Identifier:
NCT05388318
Other Study ID Numbers:
  • 00015014
First Posted:
May 24, 2022
Last Update Posted:
May 24, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Weight Loss
Cognitive Dysfunction

Study Results

No Results Posted as of May 24, 2022