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Time Restricted EATing (TREAT) Pilot Study

Study Description
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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Pre Diabetes Behavioral: TREAT pilot intervention Not Applicable

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 Design
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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
Arms and Interventions
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 Name: TREAT

Outcome Measures
Primary Outcome Measures :
  1. Percentage of participants logging [ Time Frame: 3 months ]
    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.

  2. Percentage of patients who reduced eating duration by 4 hours [ Time Frame: 3 months ]
    Change in eating duration from pre- to post-intervention will be calculated in from data collected in hours spent eating


Secondary Outcome Measures :
  1. % weight loss achieved post-intervention [ Time Frame: Baseline to 3 months ]
    Weight will be recorded and compared at baseline and 3 months.

  2. Average time in duration of overnight fasting [ Time Frame: 3 months ]
    Hours of overnight fasting will be recorded.

  3. Average time in sleep duration [ Time Frame: 3 months ]
    Hours of sleep each night will be recorded.

  4. Adherence to using the app [ Time Frame: 3 months ]
    Participants that completed daily food logs in app, and have days completed with correct eating duration.

  5. % of participants who achieve ≥ 5% weight loss [ Time Frame: Baseline to 3 months ]
    Weight will be recorded and compared at baseline and 3 months.


Eligibility Criteria
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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
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Blandine Laferrère, M.D., PhD. 212-851-5562 BBL14@columbia.edu
Contact: Malini Prasad, M.S. 212-851-5531 map2329@cumc.columbia.edu

Locations
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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      
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Blandine Laferrère, M.D., PhD. Columbia University
Tracking Information
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
 (submitted: May 17, 2019)
  • Percentage of participants logging [ Time Frame: 3 months ]
    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.
  • Percentage of patients who reduced eating duration by 4 hours [ Time Frame: 3 months ]
    Change in eating duration from pre- to post-intervention will be calculated in from data collected in hours spent eating
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2019)
  • % weight loss achieved post-intervention [ Time Frame: Baseline to 3 months ]
    Weight will be recorded and compared at baseline and 3 months.
  • Average time in duration of overnight fasting [ Time Frame: 3 months ]
    Hours of overnight fasting will be recorded.
  • Average time in sleep duration [ Time Frame: 3 months ]
    Hours of sleep each night will be recorded.
  • Adherence to using the app [ Time Frame: 3 months ]
    Participants that completed daily food logs in app, and have days completed with correct eating duration.
  • % of participants who achieve ≥ 5% weight loss [ Time Frame: Baseline to 3 months ]
    Weight will be recorded and compared at baseline and 3 months.
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.

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
Condition  ICMJE
  • Overweight and Obesity
  • Pre Diabetes
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
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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 17, 2019)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 73 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Blandine Laferrère, M.D., PhD. 212-851-5562 BBL14@columbia.edu
Contact: Malini Prasad, M.S. 212-851-5531 map2329@cumc.columbia.edu
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Blandine Laferrere, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Blandine Laferrère, M.D., PhD. Columbia University
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