Time Restricted EATing (TREAT) Pilot Study

Overweight and Obesity Clinical Trial

Official title:

Time Restricted EATing (TREAT) Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03956290
• Other study ID #: AAAS3053
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: January 11, 2021

Study information

• Verified date: July 2021
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 11, 2021
• Est. primary completion date: January 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 73 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Overweight
• Overweight and Obesity
• Pre Diabetes
• Prediabetic State

Intervention

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.

Locations

Country	Name	City	State
United States	Obesity Nutrition Research Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Prasad M, Fine K, Gee A, Nair N, Popp CJ, Cheng B, Manoogian ENC, Panda S, Laferrère 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. 202 — View Citation

Outcome

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