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ACTIVE NOT RECRUITING

NCT04465721

TREAT to Improve Cardiometabolic Health

Sponsor: Columbia University

View on ClinicalTrials.gov

Summary

Over half of American adults have overweight or obesity and are at high risk of developing type 2 diabetes and cardiovascular diseases. Although caloric restriction has many health benefits, it is difficult to sustain overtime for most people. Time restricted eating (TRE), a novel type of intermittent fasting, facilitates adherence to the intervention and results in weight loss and improvement of metabolism. The investigators propose to examine the efficacy of self-monitoring and TRE (10-h/d) vs. self-monitoring and habitual prolonged eating duration (HABIT) (13 hours/d) on weight loss and body composition, metabolic function and circadian biology, in metabolically unhealthy adults aged 50 to 75 y old, with overweight or obesity. The investigators hypothesize that TRE, compared to habitual long duration of eating, will decrease cardiovascular risk burden.

Official title: New York TREAT (Time Restricted EATing) to Improve Cardiometabolic Health Study

Key Details

Gender

All

Age Range

50 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2021-06-14

Completion Date

2026-06-30

Last Updated

2025-05-18

Healthy Volunteers

Conditions

Overweight and Obesity Prediabetes

Interventions

BEHAVIORAL

TRE

The TRE intervention will be administered and monitored via the study app. It combines self-monitoring behavior, daily eating window reminders, positive reinforcement based on number of log entries or based on meeting eating widow target, and basic lifestyle text messages. It also allows research staff to monitor in real-time, via the backend cloud, adherence to self-monitoring, and to reducing the eating window.

BEHAVIORAL

HABIT

The HABIT intervention will be administered and monitored via the study app. It combines self-monitoring behavior, positive reinforcement based on number of log entries, and basic lifestyle text messages. It also allows research staff to monitor in real-time, via the backend cloud, adherence to self-monitoring.

Inclusion Criteria: * age: 50-75y old * BMI ≥25 and ≤45 kg/m2 * a diagnosis of prediabetes AND/OR fasting glucose 100 mg/dL and/or HbA1c 5.7% OR Type 2 Diabetes diet-controlled and/or treated with metformin AND meeting 2 or more of the following metabolic syndrome criteria: * diagnosis of hypertension on stable medication regimen * blood pressure \>120/\>80 mmHg * A diagnosis of dyslipidemia on stable regimen * triglycerides 150 mg/dL * HDL cholesterol men \<40 mg/dL and women \<50 mg/dL * waist circumference men: \>102 cm (\>40 in); women \>88 cm (\>35 in) * in possession of a smart phone (iPhone or Android) * 70% of days with logging adherence (2 or more log entries/day separated by at least 5h) * Sleep duration 6-h, with habitual self-reported wake up time \>5AM and before 11 AM and average self reported bed time \<2AM * habitually eat breakfast * with weight stability within 5% of screening for the last 3 months * English speaking (the App has not yet been translated) * must live in the New York City metro area Exclusion criteria: * sleep disorder, e.g. known obstructive sleep apnea (OSA) on CPAP, severe OSA with apnea-hypopnea index \>30 events/h, significant daytime symptoms of OSA, periodic limb movements of sleep, narcolepsy, current shift work or in last 6-mo, travel more than 1 time zone during intervention; severe insomnia with score 15 on Insomnia Severity Index * significant organ system dysfunction/disease: severe pulmonary, kidney or cardiovascular disease; evidence of active illness (e.g., fever) * history of seizure disorder * previous bariatric surgery or on weight loss medication * history of or current significant food intake or psychiatric disorder * use of 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) * anemia (hemoglobin \<10 g/dl and hematocrit \<30%) * have conditions that render individual unable to complete all testing procedures \[e.g., unable to stay overnight or frequent travel across 1 time zones\] * extreme early and late chronotypes (\> 2AM bed time and wake up time before 5AM and \> 11AM) * severe food allergies * unwilling/unable to provide informed consent

Locations (1)

Columbia University

New York, New York, United States