Time Restricted Eating for Weight Loss Maintenance

NCT ID: NCT05742165

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-17
• Study Completion Date: 2025-01-06

Brief 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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Time-Restricted Eating - 6 Hours (TRE6)

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

Group Type: EXPERIMENTAL

Time Restricted Eating (TRE)

Intervention Type: BEHAVIORAL

TRE involves only consuming food and beverages during a particular consecutive time period - in the case of this study, either 6 hours or 10 hours. Participants will self-select the timing of their first eating occasion of the day, with the provision that their first meal of the day will be consumed within 3 hours of their wake- up time and finished no less than 3 hours prior to bed time. During the fasting period, participants will be encouraged to drink water, and will be permitted to consume zero-calorie beverages. Participants will be instructed to self-monitor all eating occasions using the MyCircadianClock (mCC) smartphone app, which date- and time-stamps all food entries. Participants will also be instructed to self-monitor their body weight daily using a Bluetooth-enabled Renpho scale, which permits remote collection of body weight.

Time-Restricted Eating - 10 Hours (TRE10)

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

Group Type: EXPERIMENTAL

Time Restricted Eating (TRE)

Intervention Type: BEHAVIORAL

TRE involves only consuming food and beverages during a particular consecutive time period - in the case of this study, either 6 hours or 10 hours. Participants will self-select the timing of their first eating occasion of the day, with the provision that their first meal of the day will be consumed within 3 hours of their wake- up time and finished no less than 3 hours prior to bed time. During the fasting period, participants will be encouraged to drink water, and will be permitted to consume zero-calorie beverages. Participants will be instructed to self-monitor all eating occasions using the MyCircadianClock (mCC) smartphone app, which date- and time-stamps all food entries. Participants will also be instructed to self-monitor their body weight daily using a Bluetooth-enabled Renpho scale, which permits remote collection of body weight.

Interventions

Time Restricted Eating (TRE)

TRE involves only consuming food and beverages during a particular consecutive time period - in the case of this study, either 6 hours or 10 hours. Participants will self-select the timing of their first eating occasion of the day, with the provision that their first meal of the day will be consumed within 3 hours of their wake- up time and finished no less than 3 hours prior to bed time. During the fasting period, participants will be encouraged to drink water, and will be permitted to consume zero-calorie beverages. Participants will be instructed to self-monitor all eating occasions using the MyCircadianClock (mCC) smartphone app, which date- and time-stamps all food entries. Participants will also be instructed to self-monitor their body weight daily using a Bluetooth-enabled Renpho scale, which permits remote collection of body weight.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• ≥5% non-surgical weight loss from NYULH-WMP and NY-MOVE! Endocrinology Weight Management Clinic in the last 3 months
• BMI between 20.5 - 45 m/kg2
• between the ages 25 to 65 years old
• own a smartphone or willing to use a smartphone if provided for self-monitoring
• Eating window >12 h per day
• <150 mins/wk of physical activity
• log at least 2 meals into the smartphone app on ≥5 days

Exclusion Criteria

• <25 years or >65 years of age
• Body weight in excess of 400lbs (181.4kg)
• 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
• currently 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 months
• 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 on ≥5 d during the screening period
• have type 1 or other conditions that would preclude restricted eating windows
• have type 2 diabetes with a HbA1c >7.0% on medications except for metformin alone
• narcolepsy
• active cancer
• organ dysfunction
• current steroid use
• daytime sleepiness with the Epworth Sleepiness Scale >10
• severe insomnia with a score ≥15 on the Insomnia Severity Index

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary A. Sevick, ScD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

22-01453

Identifier Type: -

Identifier Source: org_study_id