ObesityTWISTNCT05742165
Time Restricted Eating for Weight Loss Maintenance
A study testing Time Restricted Eating (TRE) in people with Obesity, run by NYU Langone Health at 1 site in United States.
Trial summary
The aim of this pilot feasibility and acceptability, randomized clinical trial will be to examine the effects of two-time restricted eating (TRE) interventions on weight loss maintenance (WLM). Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Time Restricted Eating (TRE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2023to 6 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 from NYULH-WMP and NY-MOVE! Endocrinology Weight Management Clinic in the last 3 months
- BMI between 20.5 - 45 m/kg2
- between the ages 25 to 65 years old
- own a smartphone or willing to use a smartphone if provided for self-monitoring
- Eating window >12 h per day
- <150 mins/wk of physical activity
- log at least 2 meals into the smartphone app on ≥5 days
Who cannot join
- <25 years or >65 years of age
- Body weight in excess of 400lbs (181.4kg)
- 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
Show all 27Show fewer
- 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
- currently on anti-obesity medications (AOMs) such as, GLP-1 analogues (exenatide, tirzepatide, semaglutide, liraglutide) and pancreatic lipase inhibitors (Orlistat/Xenical and Alli)
- prescribed medications expected to result in weight loss such as Orlistat, Naltrexone, Bupropion, Lorcaserin, Phentermine, Topiramate, or Liraglutide, and who are unwilling to delay treatment with these medications for the next 3 months
- 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 on ≥5 d during the screening period
- have type 1 or other conditions that would preclude restricted eating windows
- have type 2 diabetes with a HbA1c >7.0% on medications except for metformin alone
- narcolepsy
- active cancer
- organ dysfunction
- current steroid use
- daytime sleepiness with the Epworth Sleepiness Scale >10
- severe insomnia with a score ≥15 on the Insomnia Severity Index
- >2.5 kg additional weight loss during run-in phase (weight regain is not an exclusion criteria)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Time Restricted Eating for Weight Loss Maintenance (TWIST): A Single-Site, Pilot Feasibility and Acceptability Randomized Clinical Trial in Adults With Recent Weight Loss
The aim of this pilot feasibility and acceptability, randomized clinical trial will be to examine the effects of two-time restricted eating (TRE) interventions on weight loss maintenance (WLM). This study will be conducted in 40 individuals with non-surgical weight loss of ≥5% initial body weight recruited from the NYU Langone Health Weight Management Program and NY-MOVE! Weight Management Clinic at the Manhattan VA. Measurements will occur at baseline, 4 and 12 weeks. Participants will be randomized with equal allocation to 2 groups: (1) TRE6 or (2) TRE10. The TRE6 will restrict their eating window to 6 hours per day and the TRE10 to 10 hours per day.
- Conditions
- Obesity
- Being tested
- Time Restricted Eating (TRE)
- Keywords
- weight loss maintenance, intermittent fasting, time-restricted eating, weight-reduced state
- Medical subject headings
- Obesity, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time Restricted Eating (TRE)Behavioural
TRE involves only consuming food and beverages during a particular consecutive time period - in the case of this study, either 6 hours or 10 hours. Participants will self-select the timing of their first eating occasion of the day, with the provision that their first meal of the day will be consumed within 3 hours of their wake- up time and finished no less than 3 hours prior to bed time. During the fasting period, participants will be encouraged to drink water, and will be permitted to consume zero-calorie beverages. Participants will be instructed to self-monitor all eating occasions using the MyCircadianClock (mCC) smartphone app, which date- and time-stamps all food entries. Participants will also be instructed to self-monitor their body weight daily using a Bluetooth-enabled Renpho scale, which permits remote collection of body weight.
| Study group | Role | What they receive |
|---|---|---|
| Time-Restricted Eating - 6 Hours (TRE6) | Experimental | Participants will be instructed to consume all daily food and beverages during their allotted 6-hour time period. Receives: Behavioral: Time Restricted Eating (TRE) |
| Time-Restricted Eating - 10 Hours (TRE10) | Experimental | Participants will be instructed to consume all daily food and beverages during their allotted 10-hour time period. Receives: Behavioral: Time Restricted Eating (TRE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention Rate
Percentage of participants who complete all study visits. Measure of feasibility.
Measured: Up to Week 12
Recruitment Rate
Number of individuals who must be approached to enroll one participant in the study. A recruitment funnel will be developed by documenting the total number of eligible patients completing the NYU Langone Health-WMP and NY- MOVE! programs losing ≥5% of their baseline body weight.
Measured: Up to Week 12
Change in TRE Experience Questionnaire (TRE-EQ) Score
Online questionnaire that includes 5-point scaled items (0=strongly disagree, 5=strongly agree) regarding difficulties encountered with hunger and appetite; eating within the assigned window; coordinating the TRE window with work, school and home demands; and accommodating social connections (e.g., behaviors and preferences of fellow diners). The total score is the average of responses and ranges from 0-5; higher scores indicate greater difficulties.
Measured: Week 4, Week 12
Adherence Rate
Using data from participant-worn ActiGraphs and on eating patterns, a day will be labeled "adherent" if all eating occasions (food or beverage with caloric value) are measured inside (± 30 minutes) their prescribed eating window. Adherence rate will be calculated by dividing the total number of adherent days by the total number of days with a logged eating occasion.
Measured: Up to Week 12
Secondary outcomes (2)
Change From Baseline in Lean Mass
Measured using Bioelectrical Impedance Analysis (BIA). Expressed in kilograms.
Measured: Baseline, Week 12
Change From Baseline in Fat Mass
Measured using BIA. Expressed in kilograms.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start17 Jul 2023
- Primary completion6 Jan 2025
- Study completion6 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies 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
- 29 participants (actual)
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
- Mary A. Sevick, ScD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742165
- Sponsor's protocol ID
- 22-01453
- Other IDs
- K99HL163474
- Acronym
- TWIST
- Status last verified
- Jul 2026
- First submitted
- 15 Feb 2023
- Last updated
- 31 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: \[collin.popp@nyulangone.org\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Restricted Eating for Weight Loss Maintenance (TWIST): A Single-Site, Pilot Feasibility and Acceptability Randomized Clinical Trial in Adults With Recent Weight Loss
- ClinicalTrials.gov ID
- NCT05742165
- Acronym / sponsor ID
- TWIST / 22-01453
- Conditions
- Obesity
- Keywords
- weight loss maintenance, intermittent fasting, time-restricted eating, weight-reduced state
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 6 Jan 2025 (actual)
- First posted
- 23 Feb 2023 (actual)
- Results
- Posted 31 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this pilot feasibility and acceptability, randomized clinical trial will be to examine the effects of two-time restricted eating (TRE) interventions on weight loss maintenance (WLM). This study will be conducted in 40 individuals with non-surgical weight loss of ≥5% initial body weight recruited from the NYU Langone Health Weight Management Program and NY-MOVE! Weight Management Clinic at the Manhattan VA. Measurements will occur at baseline, 4 and 12 weeks. Participants will be randomized with equal allocation to 2 groups: (1) TRE6 or (2) TRE10. The TRE6 will restrict their eating window to 6 hours per day and the TRE10 to 10 hours per day.
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 - 6 Hours (TRE6) | Experimental | Behavioral: Time Restricted Eating (TRE)Participants will be instructed to consume all daily food and beverages during their allotted 6-hour time period. |
| Time-Restricted Eating - 10 Hours (TRE10) | Experimental | Behavioral: Time Restricted Eating (TRE)Participants will be instructed to consume all daily food and beverages during their allotted 10-hour time period. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥5% non-surgical weight loss from NYULH-WMP and NY-MOVE! Endocrinology Weight Management Clinic in the last 3 months
- BMI between 20.5 - 45 m/kg2
- between the ages 25 to 65 years old
- own a smartphone or willing to use a smartphone if provided for self-monitoring
- Eating window >12 h per day
Key exclusion criteria (27 listed)
- <25 years or >65 years of age
- Body weight in excess of 400lbs (181.4kg)
- pregnant, trying to get pregnant or breastfeeding
- previous or planned bariatric surgery
- previous or current history of eating disorder
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 |
|---|---|---|
| Time Restricted Eating (TRE)TRE involves only consuming food and beverages during a particular consecutive time period - in the case of this study, either 6 hours or 10 hours. Participants will self-select the timing of their first eating occasion of the day, with the provision that their first meal of the day will be consumed within 3 hours of their wake- up time and finished no less than 3 hours prior to bed time. During the fasting period, participants will be encouraged to drink water, and will be permitted to consume zero-calorie beverages. Participants will be instructed to self-monitor all eating occasions using the MyCircadianClock (mCC) smartphone app, which date- and time-stamps all food entries. Participants will also be instructed to self-monitor their body weight daily using a Bluetooth-enabled Renpho scale, which permits remote collection of body weight. | Behavioural | Time-Restricted Eating - 10 Hours (TRE10), Time-Restricted Eating - 6 Hours (TRE6) |
Primary outcome
Retention Rate
Time frame: Up to Week 12
Percentage of participants who complete all study visits. Measure of feasibility.
Recruitment Rate
Time frame: Up to Week 12
Number of individuals who must be approached to enroll one participant in the study. A recruitment funnel will be developed by documenting the total number of eligible patients completing the NYU Langone Health-WMP and NY- MOVE! programs losing ≥5% of their baseline body weight.
Change in TRE Experience Questionnaire (TRE-EQ) Score
Time frame: Week 4, Week 12
Online questionnaire that includes 5-point scaled items (0=strongly disagree, 5=strongly agree) regarding difficulties encountered with hunger and appetite; eating within the assigned window; coordinating the TRE window with work, school and home demands; and accommodating social connections (e.g., behaviors and preferences of fellow diners). The total score is the average of responses and ranges from 0-5; higher scores indicate greater difficulties.
Adherence Rate
Time frame: Up to Week 12
Using data from participant-worn ActiGraphs and on eating patterns, a day will be labeled "adherent" if all eating occasions (food or beverage with caloric value) are measured inside (± 30 minutes) their prescribed eating window. Adherence rate will be calculated by dividing the total number of adherent days by the total number of days with a logged eating occasion.
2 secondary outcomes
Change From Baseline in Lean Mass
Time frame: Baseline, Week 12
Change From Baseline in Fat Mass
Time frame: Baseline, Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [collin.popp@nyulangone.org]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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. This study is not recruiting at the moment.
Mary A. Sevick, ScD 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 Time Restricted Eating (TRE) in people with Obesity, 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 7 inclusion and 27 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: finished, as of the sponsor's last update on 31 Jul 2026. 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?
Yes. Results are posted in the registry (first posted 31 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention Rate (time frame: Up to Week 12). The study lists 4 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 31 Jul 2026.