TWIST 2.0 Study: Time Restricted Eating for Weight Loss Maintenance

The TWIST 2.0 Study is looking at whether Time Restricted Eating (TRE) can help adults who have recently lost weight keep it off. You could be eligible if you are between 25 and 65 years old, have lost at least 5% of your body weight non-surgically in the last three months, and have a current BMI (Body Mass Index) between 20.5 and 45. Participants will be randomly assigned to either follow a 10-hour eating window (TRE) or receive general advice on weight-loss maintenance. The study will measure changes in body weight and the percentage of participants who successfully maintain their weight loss over 12 months. The current recruitment status is unclear.

Study design
This is a 12-month study with two groups, involving 110 participants. You will be randomly assigned to one of the two groups.
What's involved
You will undergo screening, a 4-week run-in period, and then participate for 12 months. This includes questionnaires, height/weight measurements, body composition scans (BIA and DEXA) at baseline, 6, and 12 months, and potentially a mixed-meal tolerance test.
Compensation
Not stated in the trial record.
Follow-up
Your body weight and weight loss maintenance will be measured at 6 and 12 months after starting the study.

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NCT07190170

Time Restricted Eating for WeIght LoSs MainTenance-2

Recruiting
NAAges 25–65InterventionalTreatment
NYU Langone Health
~110 participants
Updated 2025-12-26 on ClinicalTrials.gov
What's tested:TREWeight-Loss Maintenance Advice

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Absolute Body Weight Change
Measured over Baseline, Month 6, Month 12
+4 more outcomes measured
Weight Loss
Weight Gain
Weight Loss Maintenance
1 sites across 1 states
New York1
  • Collin Popp · PRINCIPAL_INVESTIGATOR · NYU Langone Health

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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,
is non-English speaking (the mCC app is currently only available in English).
  • Absolute Body Weight ChangeBaseline, Month 6, Month 12
  • Percent Body Weight ChangeBaseline, Month 6, Month 12
  • Percentage of Participants with Successful Weight Loss-Maintenance (WLM)Baseline, Month 6, Month 12

    WLM defined as regaining ≤25% of initial weight loss.

  • Absolute Fat Mass Change Measured with DEXABaseline, Month 6, Month 12

    Assessed using dual-energy x-ray absorptiometry (DEXA) scan.

  • Percent Fat Mass Change Measured with DEXABaseline, Month 6, Month 12

    Assessed using dual-energy x-ray absorptiometry (DEXA) scan.