Trial Outcomes & Findings for Time Restricted Eating for Weight Loss Maintenance (NCT NCT05742165)
NCT ID: NCT05742165
Last Updated: 2026-07-31
Results Overview
Percentage of participants who complete all study visits. Measure of feasibility.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
Up to Week 12
Results posted on
2026-07-31
Participant Flow
Participant milestones
| Measure |
Time-Restricted Eating - 6 Hours (TRE6)
Participants will be instructed to consume all daily food and beverages during their allotted 6-hour time period.
Time Restricted Eating (TRE): 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.
|
Time-Restricted Eating - 10 Hours (TRE10)
Participants will be instructed to consume all daily food and beverages during their allotted 10-hour time period.
Time Restricted Eating (TRE): 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.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Time-Restricted Eating - 6 Hours (TRE6)
Participants will be instructed to consume all daily food and beverages during their allotted 6-hour time period.
Time Restricted Eating (TRE): 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.
|
Time-Restricted Eating - 10 Hours (TRE10)
Participants will be instructed to consume all daily food and beverages during their allotted 10-hour time period.
Time Restricted Eating (TRE): 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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Time Restricted Eating for Weight Loss Maintenance
Baseline characteristics by cohort
| Measure |
Time-Restricted Eating - 6 Hours (TRE6)
n=11 Participants
Participants will be instructed to consume all daily food and beverages during their allotted 6-hour time period.
Time Restricted Eating (TRE): 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.
|
Time-Restricted Eating - 10 Hours (TRE10)
n=11 Participants
Participants will be instructed to consume all daily food and beverages during their allotted 10-hour time period.
Time Restricted Eating (TRE): 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.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 9.3 • n=9 Participants
|
46 years
STANDARD_DEVIATION 12.3 • n=27 Participants
|
46 years
STANDARD_DEVIATION 10.6 • n=267 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
16 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=9 Participants
|
10 Participants
n=27 Participants
|
20 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
11 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=9 Participants
|
11 participants
n=27 Participants
|
22 participants
n=267 Participants
|
PRIMARY outcome
Timeframe: Up to Week 12Percentage of participants who complete all study visits. Measure of feasibility.
Outcome measures
| Measure |
Time-Restricted Eating - 6 Hours (TRE6)
n=11 Participants
Participants will be instructed to consume all daily food and beverages during their allotted 6-hour time period.
Time Restricted Eating (TRE): 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.
|
Time-Restricted Eating - 10 Hours (TRE10)
n=11 Participants
Participants will be instructed to consume all daily food and beverages during their allotted 10-hour time period.
Time Restricted Eating (TRE): 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.
|
|---|---|---|
|
Retention Rate
|
81.8 Percentage of participants
|
72.7 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 12Population: As it took 15 individuals to be approached to enroll one participant, the total number of participants analyzed is 165 (i.e., 11 participants enrolled in each arm).
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.
Outcome measures
| Measure |
Time-Restricted Eating - 6 Hours (TRE6)
n=165 Participants
Participants will be instructed to consume all daily food and beverages during their allotted 6-hour time period.
Time Restricted Eating (TRE): 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.
|
Time-Restricted Eating - 10 Hours (TRE10)
n=165 Participants
Participants will be instructed to consume all daily food and beverages during their allotted 10-hour time period.
Time Restricted Eating (TRE): 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.
|
|---|---|---|
|
Recruitment Rate
|
15 participants
|
15 participants
|
PRIMARY outcome
Timeframe: Week 4, Week 12Population: Analysis shows the difference in TRE-EQ score between 4 and 12 weeks. Four participants (2 from TRE-6, 2 from TRE-10) were not included in this analysis d/t no data at 4 and/or 12 weeks, out of a total of 22 participants.
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). The total score is the average of responses and ranges from 0-5; higher scores indicate greater difficulties.
Outcome measures
| Measure |
Time-Restricted Eating - 6 Hours (TRE6)
n=9 Participants
Participants will be instructed to consume all daily food and beverages during their allotted 6-hour time period.
Time Restricted Eating (TRE): 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.
|
Time-Restricted Eating - 10 Hours (TRE10)
n=9 Participants
Participants will be instructed to consume all daily food and beverages during their allotted 10-hour time period.
Time Restricted Eating (TRE): 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.
|
|---|---|---|
|
Change in TRE Experience Questionnaire (TRE-EQ) Score
|
2.44 score on a scale
Standard Deviation 1.42
|
-0.67 score on a scale
Standard Deviation 0.02
|
PRIMARY outcome
Timeframe: Up to Week 12Population: This outcome could not be analyzed due to faulty/technical issues with ActiGraph that prohibited the collection of any data. As such, this outcome was not measured.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12Population: 5 participants were not included in this analysis due to incomplete data (2 from TRE6, 3 from TRE10) out of 22 total participants.
Measured using Bioelectrical Impedance Analysis (BIA). Expressed in kilograms.
Outcome measures
| Measure |
Time-Restricted Eating - 6 Hours (TRE6)
n=9 Participants
Participants will be instructed to consume all daily food and beverages during their allotted 6-hour time period.
Time Restricted Eating (TRE): 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.
|
Time-Restricted Eating - 10 Hours (TRE10)
n=8 Participants
Participants will be instructed to consume all daily food and beverages during their allotted 10-hour time period.
Time Restricted Eating (TRE): 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.
|
|---|---|---|
|
Change From Baseline in Lean Mass
|
-0.58 Kilograms fat-free mass
Standard Deviation 1.27
|
-2.07 Kilograms fat-free mass
Standard Deviation 2.64
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: 5 participants were not included in this analysis due to incomplete data (2 from TRE6, 3 from TRE10) out of 22 total participants.
Measured using BIA. Expressed in kilograms.
Outcome measures
| Measure |
Time-Restricted Eating - 6 Hours (TRE6)
n=9 Participants
Participants will be instructed to consume all daily food and beverages during their allotted 6-hour time period.
Time Restricted Eating (TRE): 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.
|
Time-Restricted Eating - 10 Hours (TRE10)
n=8 Participants
Participants will be instructed to consume all daily food and beverages during their allotted 10-hour time period.
Time Restricted Eating (TRE): 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.
|
|---|---|---|
|
Change From Baseline in Fat Mass
|
1.21 Kilograms of fat mass
Standard Deviation 3.13
|
-0.81 Kilograms of fat mass
Standard Deviation 2.51
|
Adverse Events
Time-Restricted Eating - 6 Hours (TRE6)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Time-Restricted Eating - 10 Hours (TRE10)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place