Clinical trial

Time Restricted Eating for WeIght LoSs MainTenance-2

Recruiting now · Not applicable · 1 countries · Registry ID NCT07190170

Recruiting nowNot applicableInterventional

What this study is about

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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age25 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionWeight Loss, Weight Gain, Weight Loss Maintenance

Full registry 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).

Treatments and study arms

TRE

Behavioral

Participants randomized to the TRE arm will be instructed to consume all food and beverages in a self-selected 10-hr eating window.

Weight-Loss Maintenance Advice

Behavioral

The CON arm participants will receive written baseline advice following randomization assignment that includes determinants associated with long-term weight-loss maintenance success (e.g., physical activity, and strategies to limit calorie intake).

Primary outcomes

Absolute Body Weight ChangeBaseline, Month 6, Month 12
Percent Body Weight ChangeBaseline, Month 6, Month 12
Percentage of Participants with Successful Weight Loss-Maintenance (WLM)Baseline, Month 6, Month 12

WLM defined as regaining ≤25% of initial weight loss.

Absolute Fat Mass Change Measured with DEXABaseline, Month 6, Month 12

Assessed using dual-energy x-ray absorptiometry (DEXA) scan.

Percent Fat Mass Change Measured with DEXABaseline, Month 6, Month 12

Assessed using dual-energy x-ray absorptiometry (DEXA) scan.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

NYU Langone Health🇺🇸 New York, New York, United States