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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TREAT pilot study | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TREAT pilot intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| % weight loss achieved post-intervention | Weight will be recorded and compared at baseline and 3 months. | Baseline to 3 months |
| Average time in duration of overnight fasting | Hours of overnight fasting will be recorded. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Blandine Laferrère, M.D., PhD. | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obesity Nutrition Research Center | New York | New York | 10032-3702 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34201442 | Result | 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. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D018149 | Glucose Intolerance |
| D000093763 | Intermittent Fasting |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| 3 months |
| Average time in sleep duration | Hours of sleep each night will be recorded. | 3 months |
| Adherence to using the app | Participants that completed daily food logs in app, and have days completed with correct eating duration. | 3 months |
| % of participants who achieve ≥ 5% weight loss | Weight will be recorded and compared at baseline and 3 months. | Baseline to 3 months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |