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Time Restricted Eating for WeIght LoSs MainTenance-2

ConditionsWeight LossWeight GainWeight Loss Maintenance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-65
SponsorNYU Langone Health

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Time-Restricted Eating (TRE)Experimental treatment 1 intervention
Group B: Baseline Advice Control (CON)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Absolute Body Weight Change

Time frame
Baseline, Month 6, Month 12
2

Percent Body Weight Change

Time frame
Baseline, Month 6, Month 12
3

Percentage of Participants with Successful Weight Loss-Maintenance (WLM)

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

Time frame
Baseline, Month 6, Month 12
4

Absolute Fat Mass Change Measured with DEXA

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

Time frame
Baseline, Month 6, Month 12

Secondary outcomes

Other outcomes

1

Incremental Area Under the Curve (iAUC) for appetite using a Visual Analog Scale (VAS)

The VAS allows participants to rate their appetite on a Likert scale from 1-10.

Time frame
Baseline, Month 6, Month 12

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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