The aim of this pilot feasibility and acceptability, randomized clinical trial will be to examine the effects of two-time restricted eating (TRE) interventions on weight loss maintenance (WLM). This study will be conducted in 40 individuals with non-surgical weight loss of ≥5% initial body weight recruited from the NYU Langone Health Weight Management Program and NY-MOVE! Weight Management Clinic at the Manhattan VA. Measurements will occur at baseline, 4 and 12 weeks. Participants will be randomized with equal allocation to 2 groups: (1) TRE6 or (2) TRE10. The TRE6 will restrict their eating window to 6 hours per day and the TRE10 to 10 hours per day.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
TRE involves only consuming food and beverages during a particular consecutive time period - in the case of this study, either 6 hours or 10 hours. Participants will self-select the timing of their first eating occasion of the day, with the provision that their first meal of the day will be consumed within 3 hours of their wake- up time and finished no less than 3 hours prior to bed time. During the fasting period, participants will be encouraged to drink water, and will be permitted to consume zero-calorie beverages. Participants will be instructed to self-monitor all eating occasions using the MyCircadianClock (mCC) smartphone app, which date- and time-stamps all food entries. Participants will also be instructed to self-monitor their body weight daily using a Bluetooth-enabled Renpho scale, which permits remote collection of body weight.
NYU Langone Health
New York, New York, United States
Retention Rate
Percentage of participants who complete all study visits. Measure of feasibility.
Time frame: Up to Week 12
Recruitment Rate
Number of individuals who must be approached to enroll one participant in the study. A recruitment funnel will be developed by documenting the total number of eligible patients completing the NYU Langone Health-WMP and NY- MOVE! programs losing ≥5% of their baseline body weight.
Time frame: Up to Week 12
TRE Experience Questionnaire (TRE-EQ) Score
Online questionnaire that includes 5-point scaled items (0=strongly disagree, 5=strongly agree) regarding difficulties encountered with hunger and appetite; eating within the assigned window; coordinating the TRE window with work, school and home demands; and accommodating social connections (e.g., behaviors and preferences of fellow diners).
Time frame: Week 12
Adherence Rate
Using data from participant-worn ActiGraphs and on eating patterns, a day will be labeled "adherent" if all eating occasions (food or beverage with caloric value) are measured inside (± 30 minutes) their prescribed eating window. Adherence rate will be calculated by dividing the total number of adherent days by the total number of days with a logged eating occasion.
Time frame: Up to Week 12
Change from Baseline in Lean Mass
Measured using Bioelectrical Impedance Analysis (BIA). Expressed in kilograms.
Time frame: Baseline, Week 12
Change from Baseline in Fat Mass
Measured using BIA. Expressed in kilograms.
Time frame: Baseline, Week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.