Time-restricted eating to help keep weight off

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a 12-month, two-arm randomized trial in adults who recently lost at least 5% of body weight. After a 4-week run-in to stabilize weight and measure baseline eating patterns, eligible participants are randomized to a time-restricted eating (≤10-hour) intervention or a control condition, with both groups receiving one-page weight-maintenance advice. Body composition is measured by bioelectrical impedance and DEXA at baseline, 6, and 12 months, and a subset complete a mixed-meal tolerance test with subjective appetite ratings. Participants self-monitor intake with a smartphone for adherence and the trial compares weight and fat mass regain between groups.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ≥5% non-surgical weight loss in the last 3 mos;
* current BMI 20.5-45 mg/kg2;
* between the ages 25 to 65 years old;
* own a smartphone or willing to use a smartphone if provided for self-monitoring. For in-person screening, eligible participants will provide signed informed consent and have their temporal eating patterns measured.

Exclusion Criteria:

* pregnant, trying to get pregnant or breastfeeding;
* previous or planned bariatric surgery;
* previous or current history of eating disorder;
* ongoing participation in another weight-management research study;
* continued participation in a weight loss program other than the proposed study;
* currently on appetite suppressants;
* currently following intermittent fasting; or skipping meals;
* eating window \<11h 59min/day;
* perform overnight shift work more than once a week;
* work that includes travel across one or more time zones;
* taking medications that affect body weight or would preclude TRE;
* unable or unwilling to provide informed consent;
* unable to participate meaningfully in the intervention (e.g., uncorrected sight and hearing impairment);
* unwilling to accept randomization assignment;
* unable to log at least 2 meals into the smartphone app for 70% (\~20 days) during of the run-in period;
* have type 1 or type 2 diabetes, or other conditions that would preclude restricted eating windows;
* narcolepsy,
* \>2.5 kg additional weight loss during run-in phase (weight regain is not an exclusion criteria);
* is non-English speaking (the mCC app is currently only available in English).

Where it's running

• NYU Langone Health
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Collin Popp — NYU Langone Health
• Study coordinator: Collin Popp
• Email: Collin.popp@nyulangone.org
• Phone: 646-501-3427

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.