An interventional study of TRE and Weight-Loss Maintenance Advice in Weight Loss, Weight Gain and Weight Loss Maintenance, sponsored by NYU Langone Health. Recruiting at 1 site in United States. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment
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).
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). Potential participants will be screened via telephone and eligible participants will attend an in-person screening visit where they will complete questionnaires and have their height and weight measured. We will perform a 4-week run-in period to establish weight stabilization and measure eating patterns before randomization. Eligible participants following the run-in period will be randomized with equal allocation to one of the 2 arms: 1) TRE intervention ≤10-hr/day TRE intervention); or 2) CON. At baseline, 6 and 12 month measurements, participants will complete a bioelectrical impedance analysis (BIA) and dual energy x-ray absorptiometry (DEXA) scan by a certified radiology technician. Within each arm, participants will be randomized to either complete or not complete a mixed meal tolerance test in which they will consume a small portion of a protein shake and complete a visual analog scale (VAS) on their subjective hunger/fullness. Participants in both arms will receive one-page handouts (i.e., "advice") on topics to assist with weight maintenance. The only between-group differences are the TRE arm will be instructed to follow a restricted eating window of ≤10 hr/day, self-monitor foods and beverages into a smartphone app, measure body weight using a Bluetooth-enabled scale, and receive behavioral counseling directed at sustaining adherence to the TRE intervention. The CON arm will be unrestricted in their eating window and encouraged to eat a habitual breakfast, lunch, and dinner. No additional contact will be made between the CON arm and interventionist during the 12 months unless we schedule a measurement visit. Digital newsletters will be provided every month for the first 6 mos, and then every other month containing complementary information on WLM to engage participants in the CON arm. The same newsletters will be going to the TRE.
317 studies on the registry are indexed under Weight Gain; 48 are open to participants now.
This study's planned enrollment of 110 is above the median of 83 across 251 interventional studies indexed under Weight Gain.
Browse Weight Gain studies →NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
Compared within Weight Gain, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Weight Loss. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to the intervention: ≤10-hour/day time restricted eating.
Behavioral: TRE
Participants assigned to receive baseline advice.
Behavioral: Weight-Loss Maintenance Advice
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).
Absolute Body Weight Change
Time frame: Baseline, Month 6, Month 12
Percent Body Weight Change
Time frame: Baseline, Month 6, Month 12
Percentage of Participants with Successful Weight Loss-Maintenance (WLM)
WLM defined as regaining ≤25% of initial weight loss.
Time frame: Baseline, Month 6, Month 12
Absolute Fat Mass Change Measured with DEXA
Assessed using dual-energy x-ray absorptiometry (DEXA) scan.
Time frame: Baseline, Month 6, Month 12
Percent Fat Mass Change Measured with DEXA
Assessed using dual-energy x-ray absorptiometry (DEXA) scan.
Time frame: Baseline, Month 6, Month 12
Incremental Area Under the Curve (iAUC) for appetite using a Visual Analog Scale (VAS)
The VAS allows participants to rate their appetite on a Likert scale from 1-10.
Time frame: Baseline, Month 6, Month 12
Plan to share: Yes — The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: collin.popp@nyulangone.org and margaret.curran@nyulangone.org. The protocol, statistical analysis plan and ICF will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access criteria: The investigator who proposes to use the data will be granted access upon reasonable request. Requests should be directed to collin.popp@nyulangone.org and margaret.curran@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.