Condition or disease | Intervention/treatment | Phase |
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Overweight and Obesity Pre Diabetes | Behavioral: TREAT pilot intervention | Not Applicable |
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 (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | Time Restricted EATing (TREAT) Pilot Study |
Actual Study Start Date : | July 1, 2019 |
Estimated Primary Completion Date : | January 2021 |
Estimated Study Completion Date : | April 2021 |
Arm | Intervention/treatment |
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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.
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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 Name: TREAT
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Ages Eligible for Study: | 45 Years to 73 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Blandine Laferrère, M.D., PhD. | 212-851-5562 | BBL14@columbia.edu | |
Contact: Malini Prasad, M.S. | 212-851-5531 | map2329@cumc.columbia.edu |
United States, New York | |
Obesity Nutrition Research Center | Recruiting |
New York, New York, United States, 10032-3702 | |
Contact: Blandine Laferrère, M.D., PhD. 212-851-5562 |
Principal Investigator: | Blandine Laferrère, M.D., PhD. | Columbia University |
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 16, 2019 | ||||||||
First Posted Date ICMJE | May 20, 2019 | ||||||||
Last Update Posted Date | September 30, 2020 | ||||||||
Actual Study Start Date ICMJE | July 1, 2019 | ||||||||
Estimated Primary Completion Date | January 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Time Restricted EATing (TREAT) Pilot Study | ||||||||
Official Title ICMJE | Time Restricted EATing (TREAT) Pilot Study | ||||||||
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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Health Services Research |
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Condition ICMJE |
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Intervention ICMJE | 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 Name: TREAT
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Study Arms ICMJE | 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.
Intervention: Behavioral: TREAT pilot intervention
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
60 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | April 2021 | ||||||||
Estimated Primary Completion Date | January 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 45 Years to 73 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03956290 | ||||||||
Other Study ID Numbers ICMJE | AAAS3053 | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Blandine Laferrere, Columbia University | ||||||||
Study Sponsor ICMJE | Columbia University | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Columbia University | ||||||||
Verification Date | September 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |