- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03956290
Time Restricted EATing (TREAT) Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10032-3702
- Obesity Nutrition Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TREAT pilot study
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.
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Participants will be asked to use the app and take pictures of everything they eat and drink, from the time they get up to the time they go to bed, regardless of size of meal/snacks/drink, for 2 weeks.
This will generate data on their eating pattern and eating duration.
Participants will be reminded through app, call or text by study staff based on personalized eating schedule.
The sleep schedule will also be recorded.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of participants logging
Time Frame: 3 months
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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.
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3 months
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Percentage of patients who reduced eating duration by 4 hours
Time Frame: 3 months
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Change in eating duration from pre- to post-intervention will be calculated in from data collected in hours spent eating
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
% weight loss achieved post-intervention
Time Frame: Baseline to 3 months
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Weight will be recorded and compared at baseline and 3 months.
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Baseline to 3 months
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Average time in duration of overnight fasting
Time Frame: 3 months
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Hours of overnight fasting will be recorded.
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3 months
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Average time in sleep duration
Time Frame: 3 months
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Hours of sleep each night will be recorded.
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3 months
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Adherence to using the app
Time Frame: 3 months
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Participants that completed daily food logs in app, and have days completed with correct eating duration.
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3 months
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% of participants who achieve ≥ 5% weight loss
Time Frame: Baseline to 3 months
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Weight will be recorded and compared at baseline and 3 months.
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Baseline to 3 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Blandine Laferrère, M.D., PhD., Columbia University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAS3053
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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