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

NCT ID: NCT05388318

Last Updated: 2024-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-17

Study Completion Date

2023-08-31

Brief Summary

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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

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Conditions

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Midlife Obese Adults With Cognitive Decline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial with 2 groups (intervention and control).
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Prolonged nightly fasting (PNF)

Group Type EXPERIMENTAL

Prolonged nightly fasting

Intervention Type BEHAVIORAL

14 hour nightly fast from caloric food and beverage; followed by 10 hour eating window. 8-week intervention duration.

Health Education Control (HEC)

Group Type ACTIVE_COMPARATOR

Health Education Control

Intervention Type BEHAVIORAL

Weekly health education video viewing related to general health topics

Interventions

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Prolonged nightly fasting

14 hour nightly fast from caloric food and beverage; followed by 10 hour eating window. 8-week intervention duration.

Intervention Type BEHAVIORAL

Health Education Control

Weekly health education video viewing related to general health topics

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Arizona State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Arizona State University

Phoenix, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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00015014

Identifier Type: -

Identifier Source: org_study_id

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