NCT05742165Completed
Time Restricted Eating for Weight Loss Maintenance
Time Restricted Eating for Weight Loss Maintenance (TWIST): A Single-Site, Pilot Feasibility and Acceptability Randomized Clinical Trial in Adults With Recent Weight Loss
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 29 (actual)
- First submitted
- 15 Feb 2023
- Start date
- 17 Jul 2023
- Primary completion date
- 6 Jan 2025
- Lead sponsor
- NYU Langone Health
- Diseases
- Obesity
- NCT number
- NCT05742165
What you commit to
- Study type: Interventional
- Participants enrolled: 29
- From 17 Jul 2023 to the primary completion date, 6 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous or planned bariatric surgery
- previous or current history of eating disorder
- currently on appetite suppressants
- 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
- current steroid use
Other illness
- unable to participate meaningfully in the intervention (e.g., uncorrected sight and hearing impairment)
- have type 1 or other conditions that would preclude restricted eating windows
- active cancer
Lab values
- have type 2 diabetes with a HbA1c \>7.0% on medications except for metformin alone
Age
- \<25 years or \>65 years of age
Other
- Body weight in excess of 400lbs (181.4kg)
- pregnant, trying to get pregnant or breastfeeding
- ongoing participation in another weight-management research study
- continued participation in a weight loss program other than the proposed study
- 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
- unable or unwilling to provide informed consent
- unwilling to accept randomization assignment
- unable to log at least 2 meals into the smartphone app on ≥5 d during the screening period
- narcolepsy
- organ dysfunction
- 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)
Who the study is looking for
- ≥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
Age in the registry: 25 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.