Time-restricted eating to help keep weight off

Time Restricted Eating for WeIght LoSs MainTenance-2 (TWIST-2): A Single-site, 2-arm Randomized Clinical Trial in Adults With Recent Weight Loss

This 12-month randomized test will see if eating only within a 10-hour daily window helps adults who recently lost weight keep it off and limit fat regain.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 25 Years to 65 Years
• Sex: All
• Sponsor: NYU Langone Health (other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT07190170 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 25–65 with recent non-surgical weight loss of ≥5% in the last 3 months, a current BMI of 20.5–45 kg/m2, and access to (or willingness to use) a smartphone are ideal candidates.

Not a fit: People who are pregnant or breastfeeding, have had or plan bariatric surgery, have current or past eating disorders, are taking appetite-suppressing or weight-altering medications, do frequent overnight shift work or already eat within a ≤12-hour window are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this approach could help people maintain weight loss and reduce fat regain using a simple daily eating-window strategy.

How similar studies have performed: Short-term trials of time-restricted eating have shown modest weight or metabolic benefits, but long-term evidence for preventing weight regain is limited.

Eligibility criteria

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 this trial is running

New York, New York

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

Study contacts

• Principal investigator: Collin Popp — NYU Langone Health
• Study coordinator: Collin Popp

Conditions: Weight Loss, Weight Gain, Weight Loss Maintenance, obesity, time-restricted eating, weight-loss maintenance