Time Restricted Eating for Weight Loss Maintenance

Obesity Clinical Trial

— TWIST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05742165
• Other study ID #: 22-01453
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2023
• Est. completion date: January 2025

Study information

• Verified date: May 2024
• Source: NYU Langone Health
• Contact: Collin Popp
• Phone: 646-501-3427
• Email: Collin.popp[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention Rate	Percentage of participants who complete all study visits. Measure of feasibility.	Up to Week 12
Primary	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
Primary	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
Primary	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	Change from Baseline in Lean Mass	Measured using Bioelectrical Impedance Analysis (BIA). Expressed in kilograms.	Baseline, Week 12
Secondary	Change from Baseline in Fat Mass	Measured using BIA. Expressed in kilograms.	Baseline, Week 12