Recruiting

TRE

Sponsor:

NYU Langone Health

Code:

NCT07190170

Conditions

Weight Loss

Weight Gain

Weight Loss Maintenance

Eligibility Criteria

Sex: All

Age: 25 - 65

Healthy Volunteers: Not accepted

Interventions

TRE

Weight-Loss Maintenance Advice

Study Details

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).

Conditions

Weight Loss

Weight Gain

Weight Loss Maintenance

Study ID

NCT07190170

Start date

Oct 1, 2025

Status verified date

Dec, 2025

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ≥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.

Exclusion Criteria:

  • 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;
  • have type 1 or type 2 diabetes, or other conditions that would preclude restricted eating windows;
  • narcolepsy,
  • >2.5 kg additional weight loss during run-in phase (weight regain is not an exclusion criteria);
  • is non-English speaking (the mCC app is currently only available in English).

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Time-Restricted Eating (TRE)

Participants assigned to the intervention: ≤10-hour/day time restricted eating.

active comparator: Baseline Advice Control (CON)

Participants assigned to receive baseline advice.

Interventions

TRE

Participants randomized to the TRE arm will be instructed to consume all food and beverages in a self-selected 10-hr eating window.

Weight-Loss Maintenance Advice

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).

Primary outcome measure

  • Absolute Body Weight Change [ Time Frame: Baseline, Month 6, Month 12 ]
  • Percent Body Weight Change [ Time Frame: Baseline, Month 6, Month 12 ]
  • Percentage of Participants with Successful Weight Loss-Maintenance (WLM) [ Time Frame: Baseline, Month 6, Month 12 ]
  • Absolute Fat Mass Change Measured with DEXA [ Time Frame: Baseline, Month 6, Month 12 ]
  • Percent Fat Mass Change Measured with DEXA [ Time Frame: Baseline, Month 6, Month 12 ]

Central Contacts and Locations

Central contacts

Collin Popp

646-501-3427Collin.popp@nyulangone.org

Margaret Curran

Margaret.curran@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Dec 26, 2025

Last verified

Dec, 2025

Keywords

  • obesity
  • time-restricted eating
  • weight-loss maintenance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2025-12-26.