Time Restricted Eating for WeIght LoSs MainTenance-2

Recruiting now · Not applicable

Conditions studied: Weight Loss, Weight Gain, Weight Loss Maintenance

In brief

The TWIST 2.0 Study is a 12-month, 2-arm RCT in adults with recent weight loss. We will examine the efficacy of TRE on weight (Aim 1a) and fat mass (Aim 1b) regain, and describe changes in subjective appetite following a mixed-meal tolerance test (Exploratory).

Key facts

Study ID

NCT07190170

Run by

NYU Langone Health

People needed

110

Starts

2025-10-01

Expected to finish

2028-01-01

Last updated by the study team

2025-12-26

Who can join

Age: 25 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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.

You may not qualify if…

• 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 is running

• NYU Langone Health — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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