Time Restricted Eating for WeIght LoSs MainTenance-2 (TWIST-2): A Single-site, 2-arm Randomized Clinical Trial in Adults With Recent Weight Loss
NYU Langone Health
Summary
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).
Description
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). 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. We will perform a 4-week run-in period to establish weight stabilization and measure eating patterns before randomization. Eligible pa…
Eligibility
- Age range
- 25–65 years
- Sex
- All
- Healthy volunteers
- No
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; * contin…
Interventions
- BehavioralTRE
Participants randomized to the TRE arm will be instructed to consume all food and beverages in a self-selected 10-hr eating window.
- BehavioralWeight-Loss Maintenance Advice
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).
Location
- NYU Langone HealthNew York, New York