Time Restricted EATing (TREAT) Pilot Study

Study Overview
=================
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.

Official Title
-----------------
Time Restricted EATing (TREAT) Pilot Study

Conditions
-----------------
Overweight and Obesity, Pre Diabetes

Intervention / Treatment
-----------------
* Behavioral: TREAT pilot intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 73 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TREAT pilot study<br>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. | Behavioral: TREAT pilot intervention<br>* 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.<br>* Other names: TREAT;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 3 months | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Time restricted eating, Overweight, Obesity, Metabolic syndrome, Diabetes treated with metformin and/or diet and HbA1C< 7%, Pre Diabetes, Circadian rhythm