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Time Restricted Eating for Weight Loss Maintenance (TWIST)

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Time Restricted Eating (TRE)
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring weight loss maintenance, intermittent fasting, time-restricted eating, weight-reduced state

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • NYU Langone HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Time-Restricted Eating - 6 Hours (TRE6)

Time-Restricted Eating - 10 Hours (TRE10)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Retention Rate
Percentage of participants who complete all study visits. Measure of feasibility.
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.
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).
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.

Secondary Outcome Measures

Change from Baseline in Lean Mass
Measured using Bioelectrical Impedance Analysis (BIA). Expressed in kilograms.
Change from Baseline in Fat Mass
Measured using BIA. Expressed in kilograms.

Full Information

First Posted
February 15, 2023
Last Updated
July 17, 2023
Sponsor
NYU Langone Health
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05742165
Brief Title
Time Restricted Eating for Weight Loss Maintenance
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
weight loss maintenance, intermittent fasting, time-restricted eating, weight-reduced state

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Time-Restricted Eating - 6 Hours (TRE6)
Arm Type
Experimental
Arm Description
Participants will be instructed to consume all daily food and beverages during their allotted 6-hour time period.
Arm Title
Time-Restricted Eating - 10 Hours (TRE10)
Arm Type
Experimental
Arm Description
Participants will be instructed to consume all daily food and beverages during their allotted 10-hour time period.
Intervention Type
Behavioral
Intervention Name(s)
Time Restricted Eating (TRE)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Retention Rate
Description
Percentage of participants who complete all study visits. Measure of feasibility.
Time Frame
Up to Week 12
Title
Recruitment Rate
Description
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.
Time Frame
Up to Week 12
Title
TRE Experience Questionnaire (TRE-EQ) Score
Description
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).
Time Frame
Week 12
Title
Adherence Rate
Description
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.
Time Frame
Up to Week 12
Secondary Outcome Measure Information:
Title
Change from Baseline in Lean Mass
Description
Measured using Bioelectrical Impedance Analysis (BIA). Expressed in kilograms.
Time Frame
Baseline, Week 12
Title
Change from Baseline in Fat Mass
Description
Measured using BIA. Expressed in kilograms.
Time Frame
Baseline, Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 >2.5 kg additional weight loss during run-in phase (weight regain is not an exclusion criteria)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Collin Popp
Phone
646-501-3427
Email
Collin.popp@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary A. Sevick, ScD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [collin.popp@nyulangone.org]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to collin.popp@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

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Time Restricted Eating for Weight Loss Maintenance

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