Time Restricted Eating for WeIght LoSs MainTenance-2

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT07190170
Status
Recruiting
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Conditions

  • Weight Gain
  • Weight Loss
  • Weight Loss Maintenance

Eligibility Criteria

Sex
ALL
Age
25 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • TRE — BEHAVIORAL
    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 — BEHAVIORAL
    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).

Study Details

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).

Key Dates

Start date
Oct 1, 2025
Status verified
Dec 2025
Primary completion
Jan 1, 2028
Completion
Jan 1, 2028

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Absolute Body Weight Change [ Time Frame: Baseline, Month 6, Month 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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By research site
NYU Langone Health· New York, NY

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