RecruitingNot ApplicableNCT07190170

Time Restricted Eating for WeIght LoSs MainTenance-2

Time Restricted Eating for WeIght LoSs MainTenance-2 (TWIST-2): A Single-site, 2-arm Randomized Clinical Trial in Adults With Recent Weight Loss


Sponsor

NYU Langone Health

Enrollment

110 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 25 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

The TWIST 2.0 study tests whether time-restricted eating (TRE) — limiting all food intake to a 10-hour window each day — helps adults maintain weight they have already lost, compared to eating without time restrictions. Weight regain after loss is a major challenge, and TRE may help by aligning eating with the body's natural circadian rhythms. Eligible participants are adults aged 25–65 who have lost at least 5% of their body weight non-surgically in the past 3 months, have a current BMI of 20.5–45 kg/m², own a smartphone, and do not have type 1 or 2 diabetes, an eating disorder, or currently follow intermittent fasting. Participation involves a 4-week run-in period, then 12 months of either following a 10-hour eating window with app-based food logging and behavioral coaching, or eating on their usual schedule, with body weight and composition measured at baseline, 6 months, and 12 months. This summary was prepared using AI to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALTRE

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

BEHAVIORALWeight-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).


Locations(1)

NYU Langone Health

New York, New York, United States

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NCT07190170


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