Time Restricted Eating for WeIght LoSs MainTenance-2
Time Restricted Eating for WeIght LoSs MainTenance-2 (TWIST-2): A Single-site, 2-arm Randomized Clinical Trial in Adults With Recent Weight Loss
NYU Langone Health
110 participants
Oct 1, 2025
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria4
- ≥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 Criteria18
- 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,
- is non-English speaking (the mCC app is currently only available in English).
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Interventions
Participants randomized to the TRE arm will be instructed to consume all food and beverages in a self-selected 10-hr eating window.
The CON arm participants will receive written baseline advice following randomization assignment that includes determinants associated with long-term weight-loss maintenance success (e.g., physical activity, and strategies to limit calorie intake).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07190170