NCT05388318

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 19, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 24, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

January 29, 2024

Status Verified

January 1, 2024

Enrollment Period

1.5 years

First QC Date

April 19, 2022

Last Update Submit

January 26, 2024

Conditions

Midlife Obese Adults With Cognitive Decline

Outcome Measures

Primary Outcomes (2)

  • Telephone Montreal Cognitive Assessment

    T-MoCA, a measure of cognitive function

    8 weeks

  • Every Day Cognition-12

    ECOG-12, a measure of cognitive function

    8 weeks

Secondary Outcomes (5)

  • Perceived Stress Scale- 10

    8 weeks

  • Rapid Eating Assessment for Participants

    8 weeks

  • Creature of Habit Scale

    8 weeks

  • Three-Factor Eating Questionnaire-Revised

    8 weeks

  • Pittsburgh Sleep Quality Index

    8 weeks

Study Arms (2)

Prolonged nightly fasting (PNF)

EXPERIMENTAL
Behavioral: Prolonged nightly fasting

Health Education Control (HEC)

ACTIVE COMPARATOR
Behavioral: Health Education Control

Interventions

Prolonged nightly fastingBEHAVIORAL

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

Prolonged nightly fasting (PNF)
Health Education ControlBEHAVIORAL

Weekly health education video viewing related to general health topics

Health Education Control (HEC)

Eligibility Criteria

Age40 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • experiencing memory loss
  • BMI 30-45.9
  • PSS-4 score ≥5
  • access to smartphone, zoom, and wifi
  • lives in United States

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled trial with 2 groups (intervention and control).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2022

First Posted

May 24, 2022

Study Start

March 17, 2022

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

January 29, 2024

Record last verified: 2024-01

Locations

US(1)