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Time Restricted EATing (TREAT) Pilot Study

Primary Purpose

Overweight and Obesity, Pre Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TREAT pilot intervention
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Overweight and Obesity focused on measuring Time restricted eating, Overweight, Obesity, Metabolic syndrome, Diabetes treated with metformin and/or diet and HbA1C< 7%, Pre Diabetes, Circadian rhythm

Eligibility Criteria

45 Years - 73 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Obesity Nutrition Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TREAT pilot study

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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

Full Information

First Posted
May 16, 2019
Last Updated
July 13, 2021
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT03956290
Brief Title
Time Restricted EATing (TREAT) Pilot Study
Official Title
Time Restricted EATing (TREAT) Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
January 11, 2021 (Actual)
Study Completion Date
January 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Pre Diabetes
Keywords
Time restricted eating, Overweight, Obesity, Metabolic syndrome, Diabetes treated with metformin and/or diet and HbA1C< 7%, Pre Diabetes, Circadian rhythm

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TREAT pilot study
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
TREAT pilot intervention
Other Intervention Name(s)
TREAT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of participants logging
Description
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.
Time Frame
3 months
Title
Percentage of patients who reduced eating duration by 4 hours
Description
Change in eating duration from pre- to post-intervention will be calculated in from data collected in hours spent eating
Time Frame
3 months
Secondary Outcome Measure Information:
Title
% weight loss achieved post-intervention
Description
Weight will be recorded and compared at baseline and 3 months.
Time Frame
Baseline to 3 months
Title
Average time in duration of overnight fasting
Description
Hours of overnight fasting will be recorded.
Time Frame
3 months
Title
Average time in sleep duration
Description
Hours of sleep each night will be recorded.
Time Frame
3 months
Title
Adherence to using the app
Description
Participants that completed daily food logs in app, and have days completed with correct eating duration.
Time Frame
3 months
Title
% of participants who achieve ≥ 5% weight loss
Description
Weight will be recorded and compared at baseline and 3 months.
Time Frame
Baseline to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
73 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Blandine Laferrère, M.D., PhD.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Obesity Nutrition Research Center
City
New York
State/Province
New York
ZIP/Postal Code
10032-3702
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34201442
Citation
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.
Results Reference
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Time Restricted EATing (TREAT) Pilot Study

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