Trial Outcomes & Findings for Daytime vs. Delayed Eating Among Obese Individuals (NCT NCT03354169)
NCT ID: NCT03354169
Last Updated: 2025-11-21
Results Overview
changes in measures of total body fat, as measured by a DEXA scan, will be explored.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
pre-post changes between the daytime and delayed eating conditions (8 weeks).
Results posted on
2025-11-21
Participant Flow
Participant milestones
| Measure |
Daytime Eating (8 Wks), Followed by Washout (2 Wks), Followed by Delayed Eating (8wks)
Participants were asked to eat on the Daytime condition first, eating all of their meals and snacks, as provided by the study, between 0800 and 1900 hr for 8 weeks. They then had a 2-week washout period eating as they liked. Finally, they were on the Delayed condition when they ate their meals between 1200 and 2300 hr for 8 weeks.
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Delayed Eating (8 Wks), Followed by Washout (2 Wks), Followed by Daytime Eating (8wks)
Participants were asked to eat on the Delated condition first, eating all of their meals and snacks, as provided by the study, between 1200 and 2300 hr for 8 weeks. They then had a 2-week washout period eating as they liked. Finally, they were on the Daytime condition when they ate their meals between 0800 and 1900 hr for 8 weeks.
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|---|---|---|
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Overall Study
STARTED
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18
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18
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Overall Study
COMPLETED
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14
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16
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Overall Study
NOT COMPLETED
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4
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2
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Daytime vs. Delayed Eating Among Obese Individuals
Baseline characteristics by cohort
| Measure |
All Study Participants
n=38 Participants
Participants will be asked to eat all of their meals and snacks, as provided by the study, between 0800h and 1900h during the Daytime condition and between 1200h and 2300h in the Delayed condition. Participants will be randomly assigned to eat per the prescribed eating condition for 8 weeks during eating condition 1. They will then have a 2-week washout period. They will complete the alternative eating condition for 8 weeks during eating condition 2. Two participants were withdrawn from the study after assessment visit 1 and were not randomized.
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|---|---|
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Age, Continuous
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34.94 years
STANDARD_DEVIATION 8.97 • n=68 Participants
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Sex: Female, Male
Female
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26 Participants
n=68 Participants
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Sex: Female, Male
Male
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12 Participants
n=68 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=68 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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37 Participants
n=68 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=68 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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1 Participants
n=68 Participants
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Race (NIH/OMB)
Asian
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2 Participants
n=68 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=68 Participants
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Race (NIH/OMB)
Black or African American
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10 Participants
n=68 Participants
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Race (NIH/OMB)
White
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25 Participants
n=68 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=68 Participants
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Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
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Region of Enrollment
United States
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38 Participants
n=68 Participants
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PRIMARY outcome
Timeframe: pre-post changes between the daytime and delayed eating conditions (each 8 weeks long)Population: Thirty participants completed the two eating conditions; six were withdrawn prior to completing at least two assessment visits.
changes in body mass, as measured by a calibrated digital scale, will be explored.
Outcome measures
| Measure |
Daytime Eating Condition
n=30 Participants
Participants will be asked to eat all of their meals and snacks, as provided by the study, between 0800 and 1900.
Eating Condition: Participants will be randomly assigned to eat per the prescribed eating condition for 8 weeks during eating condition 1. They will complete the alternate eating condition for 8 weeks during eating condition 2.
|
Delayed Eating Condition
n=30 Participants
Participants will be asked to eat all of their meals and snacks, as provided by the study, between 1200 and 2300.
Eating Condition: Participants will be randomly assigned to eat per the prescribed eating condition for 8 weeks during eating condition 1. They will complete the alternate eating condition for 8 weeks during eating condition 2.
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|---|---|---|
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Body Mass (Weight)
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-2.1067 kg
Standard Deviation 3.8373
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-2.1887 kg
Standard Deviation 2.7237
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PRIMARY outcome
Timeframe: pre-post changes between the daytime and delayed eating conditions (8 weeks).changes in measures of total body fat, as measured by a DEXA scan, will be explored.
Outcome measures
| Measure |
Daytime Eating Condition
n=30 Participants
Participants will be asked to eat all of their meals and snacks, as provided by the study, between 0800 and 1900.
Eating Condition: Participants will be randomly assigned to eat per the prescribed eating condition for 8 weeks during eating condition 1. They will complete the alternate eating condition for 8 weeks during eating condition 2.
|
Delayed Eating Condition
n=30 Participants
Participants will be asked to eat all of their meals and snacks, as provided by the study, between 1200 and 2300.
Eating Condition: Participants will be randomly assigned to eat per the prescribed eating condition for 8 weeks during eating condition 1. They will complete the alternate eating condition for 8 weeks during eating condition 2.
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|---|---|---|
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Adiposity - Total Body Fat
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-0.3300 percentage of total body mass
Standard Deviation 1.8217
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-0.4833 percentage of total body mass
Standard Deviation 1.2862
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PRIMARY outcome
Timeframe: pre-post changes between the daytime and delayed eating conditions (8 weeks).Changes in resting energy expenditure values will be explored.
Outcome measures
| Measure |
Daytime Eating Condition
n=30 Participants
Participants will be asked to eat all of their meals and snacks, as provided by the study, between 0800 and 1900.
Eating Condition: Participants will be randomly assigned to eat per the prescribed eating condition for 8 weeks during eating condition 1. They will complete the alternate eating condition for 8 weeks during eating condition 2.
|
Delayed Eating Condition
n=30 Participants
Participants will be asked to eat all of their meals and snacks, as provided by the study, between 1200 and 2300.
Eating Condition: Participants will be randomly assigned to eat per the prescribed eating condition for 8 weeks during eating condition 1. They will complete the alternate eating condition for 8 weeks during eating condition 2.
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|---|---|---|
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Energy Homeostasis Outcomes - REE
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-32.4723 kcals per day
Standard Deviation 260.8070
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47.0390 kcals per day
Standard Deviation 240.9396
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PRIMARY outcome
Timeframe: pre-post changes between the daytime and delayed eating conditions (8 weeks).Respiratory quotient (RQ) was measured with a Parvo-Medics metabolic cart. It is calculated from the ratio of carbon dioxide produced by the body to oxygen consumed by the body, when the body is in a steady state.
Outcome measures
| Measure |
Daytime Eating Condition
n=30 Participants
Participants will be asked to eat all of their meals and snacks, as provided by the study, between 0800 and 1900.
Eating Condition: Participants will be randomly assigned to eat per the prescribed eating condition for 8 weeks during eating condition 1. They will complete the alternate eating condition for 8 weeks during eating condition 2.
|
Delayed Eating Condition
n=30 Participants
Participants will be asked to eat all of their meals and snacks, as provided by the study, between 1200 and 2300.
Eating Condition: Participants will be randomly assigned to eat per the prescribed eating condition for 8 weeks during eating condition 1. They will complete the alternate eating condition for 8 weeks during eating condition 2.
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|---|---|---|
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Energy Homeostasis - Respiratory Quotient
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-0.203 ratio of CO2 produced/O2 consumed
Standard Deviation 0.0607
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-0.0197 ratio of CO2 produced/O2 consumed
Standard Deviation 0.6499
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Adverse Events
Daytime Eating Condition
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Delayed Eating Condition
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Non-randomized Participants
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Daytime Eating Condition
n=36 participants at risk
Adverse events that were experienced during the pre- or post-daytime eating condition inpatient assessment visits are reported in this group.
No AEs were reported outside of the assessment visits.
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Delayed Eating Condition
n=36 participants at risk
Adverse events that were experienced at the pre- or post- Delayed Eating Condition assessment visits are presented in this group.
No AEs were reported outside of the assessment visits.
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Non-randomized Participants
n=2 participants at risk
Two participants experienced adverse events at their first inpatient assessment visits and withdrew from the study. There were not randomized to an eating condition (this occurred at the conclusion of assessment visit 1).
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|---|---|---|---|
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Psychiatric disorders
panic attack
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0.00%
0/36 • We collected adverse event data for up to ~24 weeks, from initial screening visit and consent through the completion of the study for each participant.
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0.00%
0/36 • We collected adverse event data for up to ~24 weeks, from initial screening visit and consent through the completion of the study for each participant.
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50.0%
1/2 • Number of events 1 • We collected adverse event data for up to ~24 weeks, from initial screening visit and consent through the completion of the study for each participant.
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Skin and subcutaneous tissue disorders
vein infiltration
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2.8%
1/36 • Number of events 1 • We collected adverse event data for up to ~24 weeks, from initial screening visit and consent through the completion of the study for each participant.
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0.00%
0/36 • We collected adverse event data for up to ~24 weeks, from initial screening visit and consent through the completion of the study for each participant.
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0.00%
0/2 • We collected adverse event data for up to ~24 weeks, from initial screening visit and consent through the completion of the study for each participant.
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Injury, poisoning and procedural complications
pain in upper left extremity
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2.8%
1/36 • Number of events 1 • We collected adverse event data for up to ~24 weeks, from initial screening visit and consent through the completion of the study for each participant.
|
0.00%
0/36 • We collected adverse event data for up to ~24 weeks, from initial screening visit and consent through the completion of the study for each participant.
|
0.00%
0/2 • We collected adverse event data for up to ~24 weeks, from initial screening visit and consent through the completion of the study for each participant.
|
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General disorders
headache
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0.00%
0/36 • We collected adverse event data for up to ~24 weeks, from initial screening visit and consent through the completion of the study for each participant.
|
5.6%
2/36 • Number of events 2 • We collected adverse event data for up to ~24 weeks, from initial screening visit and consent through the completion of the study for each participant.
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0.00%
0/2 • We collected adverse event data for up to ~24 weeks, from initial screening visit and consent through the completion of the study for each participant.
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Endocrine disorders
hypoglycemia
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2.8%
1/36 • Number of events 1 • We collected adverse event data for up to ~24 weeks, from initial screening visit and consent through the completion of the study for each participant.
|
0.00%
0/36 • We collected adverse event data for up to ~24 weeks, from initial screening visit and consent through the completion of the study for each participant.
|
50.0%
1/2 • Number of events 1 • We collected adverse event data for up to ~24 weeks, from initial screening visit and consent through the completion of the study for each participant.
|
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Eye disorders
sub-conjunctive hemorrhage
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0.00%
0/36 • We collected adverse event data for up to ~24 weeks, from initial screening visit and consent through the completion of the study for each participant.
|
2.8%
1/36 • Number of events 1 • We collected adverse event data for up to ~24 weeks, from initial screening visit and consent through the completion of the study for each participant.
|
0.00%
0/2 • We collected adverse event data for up to ~24 weeks, from initial screening visit and consent through the completion of the study for each participant.
|
|
Skin and subcutaneous tissue disorders
non-infected phlebitis
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13.9%
5/36 • Number of events 5 • We collected adverse event data for up to ~24 weeks, from initial screening visit and consent through the completion of the study for each participant.
|
2.8%
1/36 • Number of events 1 • We collected adverse event data for up to ~24 weeks, from initial screening visit and consent through the completion of the study for each participant.
|
0.00%
0/2 • We collected adverse event data for up to ~24 weeks, from initial screening visit and consent through the completion of the study for each participant.
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Gastrointestinal disorders
vomiting
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0.00%
0/36 • We collected adverse event data for up to ~24 weeks, from initial screening visit and consent through the completion of the study for each participant.
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8.3%
3/36 • Number of events 3 • We collected adverse event data for up to ~24 weeks, from initial screening visit and consent through the completion of the study for each participant.
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0.00%
0/2 • We collected adverse event data for up to ~24 weeks, from initial screening visit and consent through the completion of the study for each participant.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place