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

January 26, 2024 updated by: Arizona State University

Weight Reduction and Cognitive Health: A Remote Randomized Controlled Pilot Study Testing a Prolonged Nightly Fasting Intervention Among Obese, Stressed Mid-life Adults

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Arizona State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Telephone Montreal Cognitive Assessment
Time Frame: 8 weeks
T-MoCA, a measure of cognitive function
8 weeks
Every Day Cognition-12
Time Frame: 8 weeks
ECOG-12, a measure of cognitive function
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Stress Scale- 10
Time Frame: 8 weeks
PSS-10, a measure of perceived stress
8 weeks
Rapid Eating Assessment for Participants
Time Frame: 8 weeks
REAPS, a measure of eating behaviors
8 weeks
Creature of Habit Scale
Time Frame: 8 weeks
COHS, a measure of habitual behavior
8 weeks
Three-Factor Eating Questionnaire-Revised
Time Frame: 8 weeks
TFEQ, a measure of eating behaviors
8 weeks
Pittsburgh Sleep Quality Index
Time Frame: 8 weeks
PSQI, a measure of sleep quality
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arizona State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2022

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

April 19, 2022

First Submitted That Met QC Criteria

May 23, 2022

First Posted (Actual)

May 24, 2022

Study Record Updates

Last Update Posted (Actual)

January 29, 2024

Last Update Submitted That Met QC Criteria

January 26, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00015014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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