Time Restricted EATing (TREAT) Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity; Pre Diabetes
• Intervention / Treatment: Behavioral: TREAT pilot intervention

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: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032-3702
      • Obesity Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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)

Number of Arms

1

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.

Behavioral: TREAT pilot intervention; 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: 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

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Blandine Laferrère, M.D., PhD., Columbia University

Publications and helpful links

General Publications

• Prasad M, Fine K, Gee A, Nair N, Popp CJ, Cheng B, Manoogian ENC, Panda S, Laferrere B. A Smartphone Intervention to Promote Time Restricted Eating Reduces Body Weight and Blood Pressure in Adults with Overweight and Obesity: A Pilot Study. Nutrients. 2021 Jun 23;13(7):2148. doi: 10.3390/nu13072148.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): January 11, 2021
• Study Completion (Actual): January 11, 2021

Study Registration Dates

• First Submitted: May 16, 2019
• First Submitted That Met QC Criteria: May 17, 2019
• First Posted (Actual): May 20, 2019

Study Record Updates

• Last Update Posted (Actual): July 19, 2021
• Last Update Submitted That Met QC Criteria: July 13, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Obesity; Metabolic syndrome; Overweight; Circadian rhythm; Time restricted eating; Pre Diabetes; Diabetes treated with metformin and/or diet and HbA1C< 7%
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Body Weight; Hyperglycemia; Prediabetic State; Glucose Intolerance; Overweight
• Other Study ID Numbers: AAAS3053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No