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OpenTrials
Completed

NCT Number: NCT05388318

Weight Reduction and Cognitive Health: Pilot Study Testing a Prolonged Testing Prolonged Fasting 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.

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Key information

Conditions

Midlife Obese Adults With Cognitive Decline

Age range

40 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University

Phoenix, Arizona, 85004, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prolonged Nightly Fasting

Behavioral

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

Health Education Control

Behavioral

Weekly health education video viewing related to general health topics

Primary outcomes

  1. Telephone Montreal Cognitive Assessment

    Time frame: 8 weeks

    T-MoCA, a measure of cognitive function

  2. Every Day Cognition-12

    Time frame: 8 weeks

    ECOG-12, a measure of cognitive function

Secondary outcomes

  1. Perceived Stress Scale- 10

    Time frame: 8 weeks

    PSS-10, a measure of perceived stress

  2. Rapid Eating Assessment for Participants

    Time frame: 8 weeks

    REAPS, a measure of eating behaviors

  3. Creature of Habit Scale

    Time frame: 8 weeks

    COHS, a measure of habitual behavior

  4. Three-Factor Eating Questionnaire-Revised

    Time frame: 8 weeks

    TFEQ, a measure of eating behaviors

  5. Pittsburgh Sleep Quality Index

    Time frame: 8 weeks

    PSQI, a measure of sleep quality

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Registry information

Official study title

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

Acronym: GetSmart

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 24, 2022
Registry last updated
Jan 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.