Time Restricted Eating for WeIght LoSs MainTenance-2
TWIST-2
2 other identifiers
interventional
110
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2025
CompletedFirst Posted
Study publicly available on registry
September 24, 2025
CompletedStudy Start
First participant enrolled
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
December 26, 2025
December 1, 2025
2.3 years
September 17, 2025
December 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Absolute Body Weight Change
Baseline, Month 6, Month 12
Percent Body Weight Change
Baseline, Month 6, Month 12
Percentage of Participants with Successful Weight Loss-Maintenance (WLM)
WLM defined as regaining ≤25% of initial weight loss.
Baseline, Month 6, Month 12
Absolute Fat Mass Change Measured with DEXA
Assessed using dual-energy x-ray absorptiometry (DEXA) scan.
Baseline, Month 6, Month 12
Percent Fat Mass Change Measured with DEXA
Assessed using dual-energy x-ray absorptiometry (DEXA) scan.
Baseline, Month 6, Month 12
Other Outcomes (1)
Incremental Area Under the Curve (iAUC) for appetite using a Visual Analog Scale (VAS)
Baseline, Month 6, Month 12
Study Arms (2)
Time-Restricted Eating (TRE)
EXPERIMENTALParticipants assigned to the intervention: ≤10-hour/day time restricted eating.
Baseline Advice Control (CON)
ACTIVE COMPARATORParticipants assigned to receive baseline advice.
Interventions
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).
Eligibility Criteria
You may qualify if:
- ≥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.
You may not qualify if:
- 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;
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Collin Popp
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2025
First Posted
September 24, 2025
Study Start
October 1, 2025
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
January 1, 2028
Last Updated
December 26, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- 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.
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.