Back to resultsWeight Reduction and Cognitive Health: Pilot Study Testing a Prolonged Testing Prolonged Fasting Among Obese, Stressed Mid-life Adults (GetSmart)
Primary Purpose
Midlife Obese Adults With Cognitive Decline
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prolonged nightly fasting
Health Education Control
Sponsored by
About this trial
This is an interventional prevention trial for Midlife Obese Adults With Cognitive Decline
Eligibility Criteria
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
Sites / Locations
- Arizona State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Prolonged nightly fasting (PNF)
Health Education Control (HEC)
Arm Description
Outcomes
Primary Outcome Measures
Telephone Montreal Cognitive Assessment
T-MoCA, a measure of cognitive function
Every Day Cognition-12
ECOG-12, a measure of cognitive function
Secondary Outcome Measures
Perceived Stress Scale- 10
PSS-10, a measure of perceived stress
Rapid Eating Assessment for Participants
REAPS, a measure of eating behaviors
Creature of Habit Scale
COHS, a measure of habitual behavior
Three-Factor Eating Questionnaire-Revised
TFEQ, a measure of eating behaviors
Pittsburgh Sleep Quality Index
PSQI, a measure of sleep quality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05388318
Brief Title
Weight Reduction and Cognitive Health: Pilot Study Testing a Prolonged Testing Prolonged Fasting Among Obese, Stressed Mid-life Adults
Acronym
GetSmart
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 17, 2022 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arizona State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Midlife Obese Adults With Cognitive Decline
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial with 2 groups (intervention and control).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prolonged nightly fasting (PNF)
Arm Type
Experimental
Arm Title
Health Education Control (HEC)
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Prolonged nightly fasting
Intervention Description
14 hour nightly fast from caloric food and beverage; followed by 10 hour eating window. 8-week intervention duration.
Intervention Type
Behavioral
Intervention Name(s)
Health Education Control
Intervention Description
Weekly health education video viewing related to general health topics
Primary Outcome Measure Information:
Title
Telephone Montreal Cognitive Assessment
Description
T-MoCA, a measure of cognitive function
Time Frame
8 weeks
Title
Every Day Cognition-12
Description
ECOG-12, a measure of cognitive function
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Perceived Stress Scale- 10
Description
PSS-10, a measure of perceived stress
Time Frame
8 weeks
Title
Rapid Eating Assessment for Participants
Description
REAPS, a measure of eating behaviors
Time Frame
8 weeks
Title
Creature of Habit Scale
Description
COHS, a measure of habitual behavior
Time Frame
8 weeks
Title
Three-Factor Eating Questionnaire-Revised
Description
TFEQ, a measure of eating behaviors
Time Frame
8 weeks
Title
Pittsburgh Sleep Quality Index
Description
PSQI, a measure of sleep quality
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Arizona State University
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Weight Reduction and Cognitive Health: Pilot Study Testing a Prolonged Testing Prolonged Fasting Among Obese, Stressed Mid-life Adults
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