NCT07190170

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

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).

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 appetite following a mixed-meal tolerance test (Exploratory). Potential participants will be screened via telephone and eligible participants will attend an in-person screening visit where they will complete questionnaires and have their height and weight measured. We will perform a 4-week run-in period to establish weight stabilization and measure eating patterns before randomization. Eligible participants following the run-in period will be randomized with equal allocation to one of the 2 arms: 1) TRE intervention ≤10-hr/day TRE intervention); or 2) CON. At baseline, 6 and 12 month measurements, participants will complete a bioelectrical impedance analysis (BIA) and dual energy x-ray absorptiometry (DEXA) scan by a certified radiology technician. Within each arm, participants will be randomized to either complete or not complete a mixed meal tolerance test in which they will consume a small portion of a protein shake and complete a visual analog scale (VAS) on their subjective hunger/fullness. Participants in both arms will receive one-page handouts (i.e., "advice") on topics to assist with weight maintenance. The only between-group differences are the TRE arm will be instructed to follow a restricted eating window of ≤10 hr/day, self-monitor foods and beverages into a smartphone app, measure body weight using a Bluetooth-enabled scale, and receive behavioral counseling directed at sustaining adherence to the TRE intervention. The CON arm will be unrestricted in their eating window and encouraged to eat a habitual breakfast, lunch, and dinner. No additional contact will be made between the CON arm and interventionist during the 12 months unless we schedule a measurement visit. Digital newsletters will be provided every month for the first 6 mos, and then every other month containing complementary information on WLM to engage participants in the CON arm. The same newsletters will be going to the TRE.

Conditions

• Weight Loss
• Weight Gain
• Weight Loss Maintenance

Interventions

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

Timeline

• Start date: 2025-10-01
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2025-09-24
• Last updated: 2025-12-26

Locations

1 site across 1 country: United States