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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05388318

Acronym

GetSmart

Enrollment

Registered

2022-05-24

Start date

2022-03-17

Completion date

2023-08-31

Last updated

2024-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Midlife Obese Adults With Cognitive Decline

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.

Interventions

BEHAVIORALProlonged nightly fasting

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

BEHAVIORALHealth Education Control

Weekly health education video viewing related to general health topics

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

40 Years to 59 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
Pittsburgh Sleep Quality Index	8 weeks	PSQI, a measure of sleep quality
Three-Factor Eating Questionnaire-Revised	8 weeks	TFEQ, a measure of eating behaviors
Rapid Eating Assessment for Participants	8 weeks	REAPS, a measure of eating behaviors

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026