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Time Restricted Eating for Weight Loss Maintenance (TWIST Trial)
N/A
Recruiting
Led By Mary A. Sevick, ScD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights
TWIST Trial Summary
This trial will study if restricted eating can help people maintain weight loss. 40 people from 2 clinics will follow either a 6 or 10 hour eating window for 12 weeks. Results measured at 4 and 12 weeks.
Who is the study for?
This trial is for adults aged 25-65 with a BMI of 20.5-45 who have lost at least 5% of their body weight without surgery, are not very physically active, and typically eat over a span of more than 12 hours daily. Excluded are those over 400lbs, pregnant or breastfeeding women, anyone with eating disorders or certain medical conditions like active cancer or severe diabetes.Check my eligibility
What is being tested?
The study tests two time-restricted eating plans for maintaining weight loss: one group eats within a 6-hour window (TRE6), the other within a 10-hour window (TRE10). Participants will be randomly assigned to these groups and monitored over a period of up to three months.See study design
What are the potential side effects?
Potential side effects may include hunger outside designated eating times, changes in energy levels throughout the day, potential impact on sleep patterns due to altered meal timing, and possible adjustment-related digestive issues.
TWIST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence Rate
Recruitment Rate
Retention Rate
+1 moreSecondary outcome measures
Change from Baseline in Fat Mass
Change from Baseline in Lean Mass
TWIST Trial Design
2Treatment groups
Experimental Treatment
Group I: Time-Restricted Eating - 6 Hours (TRE6)Experimental Treatment1 Intervention
Participants will be instructed to consume all daily food and beverages during their allotted 6-hour time period.
Group II: Time-Restricted Eating - 10 Hours (TRE10)Experimental Treatment1 Intervention
Participants will be instructed to consume all daily food and beverages during their allotted 10-hour time period.
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Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,840 Previous Clinical Trials
47,852,074 Total Patients Enrolled
251 Trials studying Obesity
206,006 Patients Enrolled for Obesity
NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,548 Total Patients Enrolled
25 Trials studying Obesity
10,945 Patients Enrolled for Obesity
Mary A. Sevick, ScDPrincipal InvestigatorNYU Langone Health
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My body weight is over 400lbs (181.4kg).I am either younger than 25 or older than 65.I currently have active cancer.My job requires me to travel across different time zones.I have been diagnosed with narcolepsy.My organs are not working properly.I have severe insomnia.I have lost more than 5% of my weight without trying in the last 3 months.I am currently taking appetite suppressants.I am currently taking medication for weight loss.I am taking or need to take weight loss drugs and can't stop for 3 months.I own a smartphone or am willing to use one for self-monitoring.I can see and hear well enough to participate in the study.I am between 25 and 65 years old.I often feel very sleepy during the day.I am currently taking steroids.I have had or am planning to have weight loss surgery.I am not open to being randomly assigned to a treatment group.I have type 2 diabetes with HbA1c over 7% and am on medication other than just metformin.
Research Study Groups:
This trial has the following groups:- Group 1: Time-Restricted Eating - 10 Hours (TRE10)
- Group 2: Time-Restricted Eating - 6 Hours (TRE6)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age range for this research study restricted to under 30 years old?
"This trial is recruiting patients aged 25 and over, but under 65."
Answered by AI
Is enrollment still open to join this investigation?
"Per the registry on clinicaltrials.gov, this study is not seeking participants at the moment, as it was last updated February 15th 2023. Though an inactive trial, there are 1061 other studies that are presently open to recruitment."
Answered by AI
Is the enrollment period open for this research study?
"This clinical trial seeks to recruit 50 obese individuals aged 25-65. The prerequisites for prospective participants are as follows: 5% recent non-surgical weight loss, BMI between 20.5 - 45 m/kg2, possession of a smartphone or the willingness to use one if provided, eating window >12 h per day, <150 mins/wk physical activity and daily logging in of two meals using an app on at least five days."
Answered by AI
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