NCT07190170Recruiting
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
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 17 Sept 2025
- Start date
- 1 Oct 2025
- Primary completion date
- 1 Jan 2028
- Lead sponsor
- NYU Langone Health
- Diseases
- Obesity
- NCT number
- NCT07190170
What you commit to
- Study type: Interventional
- Planned participants: 110
- From 1 Oct 2025 to the primary completion date, 1 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous or planned bariatric surgery;
- previous or current history of eating disorder;
- currently on appetite suppressants;
- taking medications that affect body weight or would preclude TRE;
Other illness
- unable to participate meaningfully in the intervention (e.g., uncorrected sight and hearing impairment);
- have type 1 or type 2 diabetes, or other conditions that would preclude restricted eating windows;
Other
- pregnant, trying to get pregnant or breastfeeding;
- ongoing participation in another weight-management research study;
- continued participation in a weight loss program other than the proposed study;
- 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;
- unable or unwilling to provide informed consent;
- 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;
- 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).
Who the study is looking for
- ≥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.
Age in the registry: 25 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.