Time Restricted EATing (TREAT) Pilot Study

Not Applicable

Completed

• Conditions: Overweight and Obesity; Pre Diabetes
• Interventions: Behavioral: TREAT pilot intervention

• Registration Number: NCT03956290
• Lead Sponsor: Columbia University

Brief Summary

The TREAT Pilot is a 3 months open-label pilot study to examine the effect of restricting the duration of eating (Time Restricted EATing) in metabolically unhealthy adults with overweight or obesity. This pilot study will allow the investigator to collect preliminary data for the design of a larger study.

Detailed Description

Disruption of the circadian rhythm, caused by aging, obesity, shift work, or prolonged daily eating duration into hours normally reserved for sleep, is a recognized risk factor for impaired metabolism and cardiovascular disease risk. Mice with disrupted clock gene have dysmetabolism. Restricting the eating window in these mice improves their metabolism.

Data will be collected to examine the feasibility and effect of a lifestyle intervention, aiming to reduce body weight in metabolically unhealthy individuals with overweight and obesity. The TREAT pilot study employs the use of mobile application to document eating behavior, when, what and how much people eat. In addition, the participants will receive reminders and complete in-person study visits to monitor their eating and sleeping schedule.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-05-16
• Study First Submitted QC: 2019-05-17
• Study First Posted: 2019-05-20
• Study Start: 2019-07-01
• Primary Completion: 2021-01-11
• Study Completion: 2021-01-11
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-13
• Last Update Posted: 2021-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• age: 45-73y old
• overweight or obesity with BMI ≥25.0 and ≤35.0 kg/m2
• pre-diabetes or diabetes only diet controlled (HbA1c <7%)
• elevated Blood Pressure (BP) 120-129/<80 mmHg or stage 1 high BP 130-139/80-89 mmHg, with clinical Atherosclerotic Cardiovascular Disease (ASCVD) or estimated 10-y Cardiovascular Disease (CVD) risk <10%
• having LDL cholesterol <150mg/dl
• no known sleep, psychiatric or food intake disorders
• in possession of a smart phone
• English-speaking
• must live in New York city geographical area and not have planned travel schedule interfering with the study

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Exclusion Criteria

• history or clinical evidence of condition that affect sleep
• significant organ system dysfunction/disease: diabetes, severe pulmonary, kidney or cardiovascular disease, and any evidence of active illness (e.g., fever)
• history of seizure disorder
• being on medications for diabetes, hypertension or dyslipidemia
• previous bariatric surgery
• history or current significant psychiatric disorder
• use dietary supplements and/or medications known to affect sleep, circadian rhythms or metabolic function
• smoking tobacco or using illegal or recreational drugs
• consume excessive alcohol (women: >14 drinks/wk; men: >21 drinks/wk)
• consume large amounts of caffeine daily (>2 cups of coffee or 8 oz caffeinated drinks per day)
• participate in intense exercise (causing heavy breathing and sweating, such as jogging) >2 d/wk for ≥35 min or moderate exercise (e.g., brisk walking) for >150 min/wk
• shift work
• extreme early and late chronotypes
• unwilling/unable to provide informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TREAT pilot study	TREAT pilot intervention	Metabolically unhealthy overweight or obese potential participants who pass an in-person screen will enroll in a 2-week run-in period when they will use the app, to assess meal patterns under habitual living conditions.

Primary Outcome Measures

Name	Time	Method
Percentage of participants logging	3 months	To measure the usage of app by recording the total number of days the participants logged in during study. Reported in percentage from 0 to 100% of time in use.
Percentage of patients who reduced eating duration by 4 hours	3 months	Change in eating duration from pre- to post-intervention will be calculated in from data collected in hours spent eating

Secondary Outcome Measures

Name	Time	Method
% weight loss achieved post-intervention	Baseline to 3 months	Weight will be recorded and compared at baseline and 3 months.
% of participants who achieve ≥ 5% weight loss	Baseline to 3 months	Weight will be recorded and compared at baseline and 3 months.
Average time in duration of overnight fasting	3 months	Hours of overnight fasting will be recorded.
Average time in sleep duration	3 months	Hours of sleep each night will be recorded.
Adherence to using the app	3 months	Participants that completed daily food logs in app, and have days completed with correct eating duration.

Trial Locations

Locations (1)

Obesity Nutrition Research Center; 🇺🇸 New York, New York, United States