Time Restricted Eating for Weight Loss Maintenance

Study Overview
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Brief Summary
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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.

Official Title
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Time Restricted Eating for Weight Loss Maintenance (TWIST): A Single-Site, Pilot Feasibility and Acceptability Randomized Clinical Trial in Adults With Recent Weight Loss

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Time Restricted Eating (TRE)


Participation Criteria
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Eligibility Criteria
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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 >2.5 kg additional weight loss during run-in phase (weight regain is not an exclusion criteria)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Time-Restricted Eating - 6 Hours (TRE6)<br>Participants will be instructed to consume all daily food and beverages during their allotted 6-hour time period. | Behavioral: Time Restricted Eating (TRE)<br>* 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.<br>|
| Experimental: Time-Restricted Eating - 10 Hours (TRE10)<br>Participants will be instructed to consume all daily food and beverages during their allotted 10-hour time period. | Behavioral: Time Restricted Eating (TRE)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention Rate | Percentage of participants who complete all study visits. Measure of feasibility. | Up to Week 12 | 
| Recruitment Rate | Number of individuals who must be approached to enroll one participant in the study. A recruitment funnel will be developed by documenting the total number of eligible patients completing the NYU Langone Health-WMP and NY- MOVE! programs losing ≥5% of their baseline body weight. | Up to Week 12 | 
| TRE Experience Questionnaire (TRE-EQ) Score | Online questionnaire that includes 5-point scaled items (0=strongly disagree, 5=strongly agree) regarding difficulties encountered with hunger and appetite; eating within the assigned window; coordinating the TRE window with work, school and home demands; and accommodating social connections (e.g., behaviors and preferences of fellow diners). | Week 12 | 
| Adherence Rate | Using data from participant-worn ActiGraphs and on eating patterns, a day will be labeled adherent if all eating occasions (food or beverage with caloric value) are measured inside (± 30 minutes) their prescribed eating window. Adherence rate will be calculated by dividing the total number of adherent days by the total number of days with a logged eating occasion. | Up to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Lean Mass | Measured using Bioelectrical Impedance Analysis (BIA). Expressed in kilograms. | Baseline, Week 12 | 
| Change from Baseline in Fat Mass | Measured using BIA. Expressed in kilograms. | Baseline, Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight loss maintenance, intermittent fasting, time-restricted eating, weight-reduced state