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

Study Overview
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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.

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

Conditions
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Midlife Obese Adults With Cognitive Decline

Intervention / Treatment
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* Behavioral: Prolonged nightly fasting
* Behavioral: Health Education Control


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial with 2 groups (intervention and control).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prolonged nightly fasting (PNF)<br> | Behavioral: Prolonged nightly fasting<br>* 14 hour nightly fast from caloric food and beverage; followed by 10 hour eating window. 8-week intervention duration.<br>|
| Active Comparator: Health Education Control (HEC)<br> | Behavioral: Health Education Control<br>* Weekly health education video viewing related to general health topics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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