Weight LossTWIST-2NCT07190170
Time Restricted Eating for WeIght LoSs MainTenance-2
A study testing TRE and Weight-Loss Maintenance Advice in people with Weight Loss and Weight Gain, run by NYU Langone Health at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Weight Loss, Weight Gain, Weight Loss Maintenance
- What is being tested?
- TRE and Weight-Loss Maintenance Advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- 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;
Show all 19Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Margaret Curran contact
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: Time Restricted Eating for WeIght LoSs MainTenance-2 (TWIST-2): A Single-site, 2-arm Randomized Clinical Trial in Adults With Recent Weight Loss
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).
Read the detailed description
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.
- Conditions
- Weight Loss, Weight Gain, Weight Loss Maintenance
- Being tested
- TRE, Weight-Loss Maintenance Advice
- Keywords
- obesity, time-restricted eating, weight-loss maintenance
- Medical subject headings
- Weight Loss, Weight Gain, Obesity, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TREBehavioural
Participants randomized to the TRE arm will be instructed to consume all food and beverages in a self-selected 10-hr eating window.
Weight-Loss Maintenance AdviceBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Time-Restricted Eating (TRE) | Experimental | Participants assigned to the intervention: ≤10-hour/day time restricted eating. Receives: Behavioral: TRE |
| Baseline Advice Control (CON) | Active comparator | Participants assigned to receive baseline advice. Receives: Behavioral: Weight-Loss Maintenance Advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Body Weight Change
Measured: Baseline, Month 6, Month 12
Percent Body Weight Change
Measured: Baseline, Month 6, Month 12
Percentage of Participants with Successful Weight Loss-Maintenance (WLM)
WLM defined as regaining ≤25% of initial weight loss.
Measured: Baseline, Month 6, Month 12
Absolute Fat Mass Change Measured with DEXA
Assessed using dual-energy x-ray absorptiometry (DEXA) scan.
Measured: Baseline, Month 6, Month 12
Percent Fat Mass Change Measured with DEXA
Assessed using dual-energy x-ray absorptiometry (DEXA) scan.
Measured: Baseline, Month 6, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start1 Oct 2025
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Collin Popp, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190170
- Sponsor's protocol ID
- 25-00320
- Other IDs
- 4R00HL163474
- Acronym
- TWIST-2
- Status last verified
- Dec 2025
- First submitted
- 17 Sep 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Restricted Eating for WeIght LoSs MainTenance-2 (TWIST-2): A Single-site, 2-arm Randomized Clinical Trial in Adults With Recent Weight Loss
- ClinicalTrials.gov ID
- NCT07190170
- Acronym / sponsor ID
- TWIST-2 / 25-00320
- Conditions
- Weight Loss, Weight Gain, Weight Loss Maintenance
- Keywords
- obesity, time-restricted eating, weight-loss maintenance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time-Restricted Eating (TRE) | Experimental | Behavioral: TREParticipants assigned to the intervention: ≤10-hour/day time restricted eating. |
| Baseline Advice Control (CON) | Active comparator | Behavioral: Weight-Loss Maintenance AdviceParticipants assigned to receive baseline advice. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥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.
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TREParticipants randomized to the TRE arm will be instructed to consume all food and beverages in a self-selected 10-hr eating window. | Behavioural | Time-Restricted Eating (TRE) |
| Weight-Loss Maintenance AdviceThe 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). | Behavioural | Baseline Advice Control (CON) |
Primary outcome
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)
Time frame: Baseline, Month 6, Month 12
WLM defined as regaining ≤25% of initial weight loss.
Absolute Fat Mass Change Measured with DEXA
Time frame: Baseline, Month 6, Month 12
Assessed using dual-energy x-ray absorptiometry (DEXA) scan.
Percent Fat Mass Change Measured with DEXA
Time frame: Baseline, Month 6, Month 12
Assessed using dual-energy x-ray absorptiometry (DEXA) scan.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Margaret Curran contact
Collin Popp principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRE and Weight-Loss Maintenance Advice in people with Weight Loss and Weight Gain, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Collin Popp (646-501-3427, Collin.popp@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute Body Weight Change (time frame: Baseline, Month 6, Month 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.