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Not Yet Recruiting NCT05742165

Time Restricted Eating for Weight Loss Maintenance

Conditions: Obesity

Sex: All
Ages: 25 Years – 65 Years
Phase: NA
Enrollment: 50
Sponsor: NYU Langone Health

Location: United States

Summary

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.

Eligibility Criteria

Inclusion Criteria:≥5% non-surgical weight loss from NYULH-WMP and NY-MOVE! Endocrinology Weight Management Clinic in the last 3 monthsBMI between 20.5 - 45 m/kg2between the ages 25 to 65 years oldown a smartphone or willing to use a smartphone if provided for self-monitoringEating window >12 h per day<150 mins/wk of physical activitylog at least 2 meals into the smartphone app on ≥5 daysExclusion Criteria:<25 years or >65 years of ageBody weight in excess of 400lbs (181.4kg)pregnant, trying to get pregnant or breastfeedingprevious or planned bariatric surgeryprevious or current history of eating disorderongoing participation in another weight-management research studycontinued participation in a weight loss program other than the proposed studycurrently on appetite suppressantscurrently following intermittent fasting or skipping mealseating window <11h 59min/dayperform overnight shift work more than once a weekwork that includes travel across one or more time zonescurrently on anti-obesity medications (AOMs) such as, GLP-1 analogues (exenatide, tirzepatide, semaglutide, liraglutide) and pancreatic lipase inhibitors (Orlistat/Xenical and Alli)prescribed medications expected to result in weight loss such as Orlistat, Naltrexone, Bupropion, Lorcaserin, Phentermine, Topiramate, or Liraglutide, and who are unwilling to delay treatment with these medications for the next 3 monthsunable or unwilling to provide informed consentunable to participate meaningfully in the intervention (e.g., uncorrected sight and hearing impairment)unwilling to accept randomization assignmentunable to log at least 2 meals into the smartphone app on ≥5 d during the screening periodhave type 1 or other conditions that would preclude restricted eating windowshave type 2 diabetes with a HbA1c >7.0% on medications except for metformin alonenarcolepsyactive cancerorgan dysfunctioncurrent steroid usedaytime sleepiness with the Epworth Sleepiness Scale >10severe insomnia with a score ≥15 on the Insomnia Severity Index>2.5 kg additional weight loss during run-in phase (weight regain is not an exclusion criteria)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05742165). StuddyBuddy aggregates publicly available trial information.