Time Restricted EATing (TREAT) Pilot Study

NCT03956290 | Completed

• 1 other identifier: AAAS3053
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• % weight loss achieved post-intervention

  Baseline to 3 months

• Average time in duration of overnight fasting

  3 months

• Average time in sleep duration

  3 months

• Adherence to using the app

  3 months

• % of participants who achieve ≥ 5% weight loss

  Baseline to 3 months

Study Arms (1)

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.

Behavioral: TREAT pilot intervention

Interventions

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.

Also known as: TREAT

TREAT pilot study

Eligibility Criteria

• Age: 45 Years - 73 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Obesity Nutrition Research Center

New York, New York, 10032-3702, United States

Location

Related Publications (1)

• 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.

  PMID: 34201442 RESULT

MeSH Terms

Conditions

Overweight; Obesity; Glucose Intolerance; Intermittent Fasting; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Fasting; Feeding Behavior; Behavior; Insulin Resistance; Hyperinsulinism

Study Officials

• Blandine Laferrère, M.D., PhD.

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 20, 2019
• Study Start: July 1, 2019
• Primary Completion: January 11, 2021
• Study Completion: January 11, 2021
• Last Updated: July 19, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)