RightFit
RecruitingNot applicable

Time Restricted Eating for WeIght LoSs MainTenance-2

Time Restricted Eating for WeIght LoSs MainTenance-2 (TWIST-2): A Single-site, 2-arm Randomized Clinical Trial in Adults With Recent Weight Loss

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
25 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, X-rays

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Potential participants will be screened via telephone and eligible participants will attend an in-person screening visit where they will complete questionnaires and have their height and weight measured."
  • "At baseline, 6 and 12 month measurements, participants will complete a bioelectrical impedance analysis (BIA) and dual energy x-ray absorptiometry (DEXA) scan by a certified radiology technician."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion 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. Exclusion Criteria: * 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).

Study sites (1)

NY