Trial Outcomes & Findings for Pilot Study of Time Restricted Feeding as a Weight Loss Intervention (NCT NCT03571048)
NCT ID: NCT03571048
Last Updated: 2022-10-25
Results Overview
Body weight will be measured via clinic scale.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
95 participants
Primary outcome timeframe
Baseline, 12 weeks
Results posted on
2022-10-25
Participant Flow
Participant milestones
| Measure |
Reduced Calorie Diet (RCD)
Participants in this group will focus on daily calorie restriction as their dietary weight loss strategy.
Reduced Calorie Diet (RCD): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD.
|
Time Restricted Feeding (TRF)
Participants in this group will focus on time restricted feeding in addition to daily calorie restriction as their dietary weight loss strategy.
Reduced Calorie Diet (RCD): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD.
Time Restricted Feeding (TRF): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD. Participants in this group will also instructed to eat only during a window of 10 hours, starting within 3 hours of waking. They will also be instructed in specific strategies to support TRF including: strategies to deal with hunger outside eating windows, distraction techniques, and choosing a balanced diet/appropriate portions during feeding windows.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
41
|
|
Overall Study
COMPLETED
|
31
|
32
|
|
Overall Study
NOT COMPLETED
|
9
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study of Time Restricted Feeding as a Weight Loss Intervention
Baseline characteristics by cohort
| Measure |
Reduced Calorie Diet (RCD)
n=40 Participants
Participants in this group will focus on daily calorie restriction as their dietary weight loss strategy.
Reduced Calorie Diet (RCD): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD.
|
Time Restricted Feeding (TRF)
n=41 Participants
Participants in this group will focus on time restricted feeding in addition to daily calorie restriction as their dietary weight loss strategy.
Reduced Calorie Diet (RCD): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD.
Time Restricted Feeding (TRF): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD. Participants in this group will also instructed to eat only during a window of 10 hours, starting within 3 hours of waking. They will also be instructed in specific strategies to support TRF including: strategies to deal with hunger outside eating windows, distraction techniques, and choosing a balanced diet/appropriate portions during feeding windows.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
37.8 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
38.3 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
38 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
41 participants
n=7 Participants
|
81 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksBody weight will be measured via clinic scale.
Outcome measures
| Measure |
Reduced Calorie Diet (RCD)
n=27 Participants
Participants in this group will focus on daily calorie restriction as their dietary weight loss strategy.
Reduced Calorie Diet (RCD): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD.
|
Time Restricted Feeding (TRF)
n=33 Participants
Participants in this group will focus on time restricted feeding in addition to daily calorie restriction as their dietary weight loss strategy.
Reduced Calorie Diet (RCD): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD.
Time Restricted Feeding (TRF): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD. Participants in this group will also instructed to eat only during a window of 10 hours, starting within 3 hours of waking. They will also be instructed in specific strategies to support TRF including: strategies to deal with hunger outside eating windows, distraction techniques, and choosing a balanced diet/appropriate portions during feeding windows.
|
|---|---|---|
|
Changes in Body Weight
|
-5.1 kg
Standard Deviation 3.2
|
-6.2 kg
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksBody composition will be assessed with dual-energy x-ray absorptiometry (DXA).
Outcome measures
| Measure |
Reduced Calorie Diet (RCD)
n=23 Participants
Participants in this group will focus on daily calorie restriction as their dietary weight loss strategy.
Reduced Calorie Diet (RCD): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD.
|
Time Restricted Feeding (TRF)
n=24 Participants
Participants in this group will focus on time restricted feeding in addition to daily calorie restriction as their dietary weight loss strategy.
Reduced Calorie Diet (RCD): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD.
Time Restricted Feeding (TRF): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD. Participants in this group will also instructed to eat only during a window of 10 hours, starting within 3 hours of waking. They will also be instructed in specific strategies to support TRF including: strategies to deal with hunger outside eating windows, distraction techniques, and choosing a balanced diet/appropriate portions during feeding windows.
|
|---|---|---|
|
Changes in Fat Mass
|
-2.1 kg
Standard Deviation 2.6
|
-2.8 kg
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksAll energy intake events will be recorded using the camera function on a cell phone application
Outcome measures
| Measure |
Reduced Calorie Diet (RCD)
n=32 Participants
Participants in this group will focus on daily calorie restriction as their dietary weight loss strategy.
Reduced Calorie Diet (RCD): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD.
|
Time Restricted Feeding (TRF)
n=32 Participants
Participants in this group will focus on time restricted feeding in addition to daily calorie restriction as their dietary weight loss strategy.
Reduced Calorie Diet (RCD): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD.
Time Restricted Feeding (TRF): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD. Participants in this group will also instructed to eat only during a window of 10 hours, starting within 3 hours of waking. They will also be instructed in specific strategies to support TRF including: strategies to deal with hunger outside eating windows, distraction techniques, and choosing a balanced diet/appropriate portions during feeding windows.
|
|---|---|---|
|
Changes in Objectively Measured Energy Intake (Camera)
|
-612.2 kcal
Standard Deviation 476
|
-647.3 kcal
Standard Deviation 773
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksStep count will be measured with activity monitors.
Outcome measures
| Measure |
Reduced Calorie Diet (RCD)
n=34 Participants
Participants in this group will focus on daily calorie restriction as their dietary weight loss strategy.
Reduced Calorie Diet (RCD): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD.
|
Time Restricted Feeding (TRF)
n=35 Participants
Participants in this group will focus on time restricted feeding in addition to daily calorie restriction as their dietary weight loss strategy.
Reduced Calorie Diet (RCD): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD.
Time Restricted Feeding (TRF): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD. Participants in this group will also instructed to eat only during a window of 10 hours, starting within 3 hours of waking. They will also be instructed in specific strategies to support TRF including: strategies to deal with hunger outside eating windows, distraction techniques, and choosing a balanced diet/appropriate portions during feeding windows.
|
|---|---|---|
|
Changes in Physical Activity
|
576 steps/day
Standard Deviation 3172
|
596 steps/day
Standard Deviation 2731
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksSitting time will be measured with activity monitors.
Outcome measures
| Measure |
Reduced Calorie Diet (RCD)
n=34 Participants
Participants in this group will focus on daily calorie restriction as their dietary weight loss strategy.
Reduced Calorie Diet (RCD): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD.
|
Time Restricted Feeding (TRF)
n=35 Participants
Participants in this group will focus on time restricted feeding in addition to daily calorie restriction as their dietary weight loss strategy.
Reduced Calorie Diet (RCD): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD.
Time Restricted Feeding (TRF): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD. Participants in this group will also instructed to eat only during a window of 10 hours, starting within 3 hours of waking. They will also be instructed in specific strategies to support TRF including: strategies to deal with hunger outside eating windows, distraction techniques, and choosing a balanced diet/appropriate portions during feeding windows.
|
|---|---|---|
|
Changes in Sedentary Behavior
|
-19.8 minutes/day
Standard Deviation 88
|
-0.77 minutes/day
Standard Deviation 82
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 weeks after completion of the 12-week intervention (i.e. at week 36)Body weight will be measured via clinic scale at 6 months post-intervention
Outcome measures
| Measure |
Reduced Calorie Diet (RCD)
n=30 Participants
Participants in this group will focus on daily calorie restriction as their dietary weight loss strategy.
Reduced Calorie Diet (RCD): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD.
|
Time Restricted Feeding (TRF)
n=30 Participants
Participants in this group will focus on time restricted feeding in addition to daily calorie restriction as their dietary weight loss strategy.
Reduced Calorie Diet (RCD): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD.
Time Restricted Feeding (TRF): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD. Participants in this group will also instructed to eat only during a window of 10 hours, starting within 3 hours of waking. They will also be instructed in specific strategies to support TRF including: strategies to deal with hunger outside eating windows, distraction techniques, and choosing a balanced diet/appropriate portions during feeding windows.
|
|---|---|---|
|
6 Month Post-Intervention Follow-Up Body Weight
|
-4.3 kg
Standard Deviation 5.3
|
-4.9 kg
Standard Deviation 5.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 weeks after completion of the 12-week intervention (i.e. at week 36)Body composition will be assessed with dual-energy x-ray absorptiometry (DXA).
Outcome measures
| Measure |
Reduced Calorie Diet (RCD)
n=30 Participants
Participants in this group will focus on daily calorie restriction as their dietary weight loss strategy.
Reduced Calorie Diet (RCD): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD.
|
Time Restricted Feeding (TRF)
n=30 Participants
Participants in this group will focus on time restricted feeding in addition to daily calorie restriction as their dietary weight loss strategy.
Reduced Calorie Diet (RCD): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD.
Time Restricted Feeding (TRF): Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD. Participants in this group will also instructed to eat only during a window of 10 hours, starting within 3 hours of waking. They will also be instructed in specific strategies to support TRF including: strategies to deal with hunger outside eating windows, distraction techniques, and choosing a balanced diet/appropriate portions during feeding windows.
|
|---|---|---|
|
6 Month Post-Intervention Follow-Up Fat Mass
|
-2.6 kg
Standard Deviation 4.4
|
-3.5 kg
Standard Deviation 4
|
Adverse Events
Reduced Calorie Diet (RCD)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Time Restricted Feeding (TRF)
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
Elizabeth Thomas, MD
University of Colorado School of Medicine
Phone: 303-724-9083
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place