Time Restricted Eating for Weight Loss Maintenance

(TWIST Trial)

Overseen By Collin Popp

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Appetite suppressants, Anti-obesity medications

Disqualifiers: Pregnancy, Bariatric surgery, Eating disorder, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

29 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The aim of this pilot feasibility and acceptability, randomized clinical trial will be to examine the effects of two-time restricted eating (TRE) interventions on weight loss maintenance (WLM). This study will be conducted in 40 individuals with non-surgical weight loss of ≥5% initial body weight recruited from the NYU Langone Health Weight Management Program and NY-MOVE! Weight Management Clinic at the Manhattan VA. Measurements will occur at baseline, 4 and 12 weeks. Participants will be randomized with equal allocation to 2 groups: (1) TRE6 or (2) TRE10. The TRE6 will restrict their eating window to 6 hours per day and the TRE10 to 10 hours per day.

Who Is on the Research Team?

Mary A. Sevick, ScD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults aged 25-65 with a BMI of 20.5-45 who have lost at least 5% of their body weight without surgery, are not very physically active, and typically eat over a span of more than 12 hours daily. Excluded are those over 400lbs, pregnant or breastfeeding women, anyone with eating disorders or certain medical conditions like active cancer or severe diabetes.

Inclusion Criteria

BMI between 20.5 - 45 m/kg2

Eating window >12 h per day

<150 mins/wk of physical activity

Exclusion Criteria

My body weight is over 400lbs (181.4kg).

I am either younger than 25 or older than 65.

I currently have active cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Initial measurements and randomization into TRE6 or TRE10 groups

1 week

1 visit (in-person)

Treatment

Participants follow their assigned time-restricted eating schedule (TRE6 or TRE10)

12 weeks

3 visits (in-person) at baseline, 4 weeks, and 12 weeks

Follow-up

Participants are monitored for weight maintenance and adherence to TRE

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Time Restricted Eating (TRE)

Trial Overview The study tests two time-restricted eating plans for maintaining weight loss: one group eats within a 6-hour window (TRE6), the other within a 10-hour window (TRE10). Participants will be randomly assigned to these groups and monitored over a period of up to three months.

How Is the Trial Designed?

Group I: Time-Restricted Eating - 6 Hours (TRE6) Experimental Treatment 1 Intervention

Participants will be instructed to consume all daily food and beverages during their allotted 6-hour time period.

Group II: Time-Restricted Eating - 10 Hours (TRE10) Experimental Treatment 1 Intervention

Participants will be instructed to consume all daily food and beverages during their allotted 10-hour time period.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+