Time Restricted Eating for Weight Loss Maintenance
TWIST
2 other identifiers
interventional
29
1 country
1
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Jul 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2023
CompletedFirst Posted
Study publicly available on registry
February 23, 2023
CompletedStudy Start
First participant enrolled
July 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 6, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 6, 2025
CompletedFebruary 11, 2026
February 1, 2026
1.5 years
February 15, 2023
February 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Retention Rate
Percentage of participants who complete all study visits. Measure of feasibility.
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.
Up to Week 12
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).
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.
Up to Week 12
Secondary Outcomes (2)
Change from Baseline in Lean Mass
Baseline, Week 12
Change from Baseline in Fat Mass
Baseline, Week 12
Study Arms (2)
Time-Restricted Eating - 6 Hours (TRE6)
EXPERIMENTALParticipants will be instructed to consume all daily food and beverages during their allotted 6-hour time period.
Time-Restricted Eating - 10 Hours (TRE10)
EXPERIMENTALParticipants will be instructed to consume all daily food and beverages during their allotted 10-hour time period.
Interventions
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.
Eligibility Criteria
You may qualify if:
- ≥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
You may not qualify if:
- \<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
- 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
- +11 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
Mary A. Sevick, ScD
NYU Langone Health
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
February 15, 2023
First Posted
February 23, 2023
Study Start
July 17, 2023
Primary Completion
January 6, 2025
Study Completion
January 6, 2025
Last Updated
February 11, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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 proposed to use the data will be granted access upon reasonable request. Requests should be directed to collin.popp@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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.