Time Restricted EATing (TREAT) Pilot Study

Columbia University64 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Overweight and Obesity Pre Diabetes

Interventions

TREAT pilot interventionBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 45 YearsMax age: 73 Years

Medical Language ↔ Plain English

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

Locations (1)

Obesity Nutrition Research Center

New York, New York, United States

Outcomes

Primary Outcomes

Percentage of participants logging

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.

Time frame: 3 months

Percentage of patients who reduced eating duration by 4 hours

Change in eating duration from pre- to post-intervention will be calculated in from data collected in hours spent eating

Time frame: 3 months

Secondary Outcomes

% weight loss achieved post-intervention

Weight will be recorded and compared at baseline and 3 months.

Time frame: Baseline to 3 months

Average time in duration of overnight fasting

Hours of overnight fasting will be recorded.

Time frame: 3 months

Average time in sleep duration

Hours of sleep each night will be recorded.

Time frame: 3 months

Adherence to using the app

Participants that completed daily food logs in app, and have days completed with correct eating duration.

Time frame: 3 months

% of participants who achieve ≥ 5% weight loss

Weight will be recorded and compared at baseline and 3 months.

Time frame: Baseline to 3 months

Data from ClinicalTrials.gov

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