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

Arizona State University (ASU)

Status: Completed

Conditions: Midlife Obese Adults With Cognitive Decline

Treatments: Behavioral: Health Education Control; Behavioral: Prolonged nightly fasting

Study type: Interventional

Funder types: Other

Identifiers

NCT05388318

00015014

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 40 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Prolonged nightly fasting (PNF)

Experimental group

Treatment:

Behavioral: Prolonged nightly fasting

Health Education Control (HEC)

Active Comparator group

Treatment:

Behavioral: Health Education Control