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Status:

RECRUITING

Time Restricted Eating for WeIght LoSs MainTenance-2

Lead Sponsor:

NYU Langone Health

Collaborating Sponsors:

National Heart, Lung, and Blood Institute (NHLBI)

Conditions:

Weight Loss

Weight Gain

Eligibility:

All Genders

25-65 years

Phase:

NA

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 ...

Detailed Description

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 ...

Eligibility Criteria

Inclusion

  • ≥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

  • 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).

Key Trial Info

Start Date :

October 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2028

Estimated Enrollment :

110 Patients enrolled

Trial Details

Trial ID

NCT07190170

Start Date

October 1 2025

End Date

January 1 2028

Last Update

December 26 2025

Active Locations (1)

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1

NYU Langone Health

New York, New York, United States, 10016