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New treatment option for Weight Loss
Official title Time Restricted Eating for WeIght LoSs MainTenance-2
ClinicalTrials.gov ID: NCT07190170
What this study is testing
- What it's testing
- The TWIST 2.0 Study is a 12-month, 2-arm RCT in adults with recent weight loss. We will examine the efficacy of TRE on weight (Aim 1a) and fat mass (Aim 1b) regain, and describe changes in subjective appetite following a mixed-meal tolerance test (Exploratory).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 65
You may be able to join if
- ≥5% non-surgical weight loss in the last 3 mos;
- current BMI 20.5-45 mg/kg2;
- between the ages 25 to 65 years old;
- own a smartphone or willing to use a smartphone if provided for self-monitoring. For in-person screening, eligible participants will provide signed...
You likely can't join if
- 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;
See the full eligibility criteria
- ≥5% non-surgical weight loss in the last 3 mos;
- current BMI 20.5-45 mg/kg2;
- between the ages 25 to 65 years old;
- own a smartphone or willing to use a smartphone if provided for self-monitoring. For in-person screening, eligible participants will provide signed informed consent and have their temporal eating patterns measured.
- 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;
- taking medications that affect body weight or would preclude TRE;
- 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 for 70% (\~20 days) during of the run-in period;
- have type 1 or type 2 diabetes, or other conditions that would preclude restricted eating windows;
- narcolepsy,
- \>2.5 kg additional weight loss during run-in phase (weight regain is not an exclusion criteria);
- is non-English speaking (the mCC app is currently only available in English).
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.