Time Restricted Eating for Weight Loss Maintenance (TWIST)

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Time Restricted Eating (TRE)

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ≥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

Exclusion Criteria:

• <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
• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Time-Restricted Eating - 6 Hours (TRE6); Participants will be instructed to consume all daily food and beverages during their allotted 6-hour time period.	Behavioral: 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.
Experimental: Time-Restricted Eating - 10 Hours (TRE10); Participants will be instructed to consume all daily food and beverages during their allotted 10-hour time period.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Lean Mass	Measured using Bioelectrical Impedance Analysis (BIA). Expressed in kilograms.	Baseline, Week 12
Change from Baseline in Fat Mass	Measured using BIA. Expressed in kilograms.	Baseline, Week 12

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Mary A. Sevick, ScD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2023
• Primary Completion (Actual): January 6, 2025
• Study Completion (Actual): January 6, 2025

Study Registration Dates

• First Submitted: February 15, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 23, 2023

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: intermittent fasting; weight loss maintenance; time-restricted eating; weight-reduced state
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Feeding Behavior; Fasting; Obesity; Intermittent Fasting
• Other Study ID Numbers: 22-01453; K99HL163474 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No