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

Not Applicable

Completed

• Conditions: Midlife Obese Adults With Cognitive Decline
• Interventions: Behavioral: Prolonged nightly fasting; Behavioral: Health Education Control

• Registration Number: NCT05388318
• Lead Sponsor: Arizona State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-17
• Study First Submitted: 2022-04-19
• Study First Submitted QC: 2022-05-23
• Study First Posted: 2022-05-24
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-26
• Last Update Posted: 2024-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prolonged nightly fasting (PNF)	Prolonged nightly fasting	-
Health Education Control (HEC)	Health Education Control	-

Primary Outcome Measures

Name	Time	Method
Telephone Montreal Cognitive Assessment	8 weeks	T-MoCA, a measure of cognitive function
Every Day Cognition-12	8 weeks	ECOG-12, a measure of cognitive function

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Arizona State University; 🇺🇸 Phoenix, Arizona, United States