NCT03956290

Time Restricted EATing (TREAT) Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 45 Years – 73 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Overweight and Obesity
• Pre Diabetes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-07-01
• Primary completion: 2021-01-11
• Completion: 2021-01-11
• First posted: 2019-05-20
• Last updated: 2021-07-19

Locations

1 site across 1 country: United States