Trial Outcomes & Findings for Time Restricted Eating Pilot - Bariatrics (NCT NCT04006366)
NCT ID: NCT04006366
Last Updated: 2020-07-17
Results Overview
Compare changes in body weight over 12 weeks in 10 bariatric patients who have undergone bariatric surgery and have completed the pilot study.
COMPLETED
NA
6 participants
baseline to 12 weeks
2020-07-17
Participant Flow
Participant milestones
| Measure |
Intervention
To test the effects of a 10-hour time restricted eating intervention before and after the 12 weeks of treatment on weight (primary), caloric and macronutrient intake, and a variety of psychosocial measures, including sleep, physical activity, blood pressure and eating behaviors (all secondary).
Time restricted feeding: We propose a pilot and feasibility trial of a 10 hour time restricted eating intervention among post-bariatric surgery patients.
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|---|---|
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Overall Study
STARTED
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6
|
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Overall Study
COMPLETED
|
5
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Overall Study
NOT COMPLETED
|
1
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Reasons for withdrawal
| Measure |
Intervention
To test the effects of a 10-hour time restricted eating intervention before and after the 12 weeks of treatment on weight (primary), caloric and macronutrient intake, and a variety of psychosocial measures, including sleep, physical activity, blood pressure and eating behaviors (all secondary).
Time restricted feeding: We propose a pilot and feasibility trial of a 10 hour time restricted eating intervention among post-bariatric surgery patients.
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|---|---|
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Overall Study
Withdrawal by Subject
|
1
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Baseline Characteristics
Time Restricted Eating Pilot - Bariatrics
Baseline characteristics by cohort
| Measure |
Intervention
n=6 Participants
To test the effects of a 10-hour time restricted eating intervention before and after the 12 weeks of treatment on weight (primary), caloric and macronutrient intake, and a variety of psychosocial measures, including sleep, physical activity, blood pressure and eating behaviors (all secondary).
Time restricted feeding: We propose a pilot and feasibility trial of a 10 hour time restricted eating intervention among post-bariatric surgery patients.
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|---|---|
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Age, Continuous
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48.7 years
STANDARD_DEVIATION 5.2 • n=5 Participants
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Sex: Female, Male
Female
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6 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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6 participants
n=5 Participants
|
|
body mass index
|
40.8 kg/m2
STANDARD_DEVIATION 4.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to 12 weeksPopulation: Six participants enrolled, and 5 completed the trial. We included 5 participants who had more than one data point to calculate weight change.
Compare changes in body weight over 12 weeks in 10 bariatric patients who have undergone bariatric surgery and have completed the pilot study.
Outcome measures
| Measure |
Intervention
n=5 Participants
To test the effects of a 10-hour time restricted eating intervention before and after the 12 weeks of treatment on weight (primary), caloric and macronutrient intake, and a variety of psychosocial measures, including sleep, physical activity, blood pressure and eating behaviors (all secondary).
Time restricted feeding: We propose a pilot and feasibility trial of a 10 hour time restricted eating intervention among post-bariatric surgery patients.
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|---|---|
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Weight
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-.07 kg
Standard Deviation 1.53
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SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: Six participants started the intervention, and we analyzed data from 5 participant who provided blood pressure measurements before and after the intervention
Compare changes from baseline to the end of the 12-week intervention in systolic blood pressure.
Outcome measures
| Measure |
Intervention
n=5 Participants
To test the effects of a 10-hour time restricted eating intervention before and after the 12 weeks of treatment on weight (primary), caloric and macronutrient intake, and a variety of psychosocial measures, including sleep, physical activity, blood pressure and eating behaviors (all secondary).
Time restricted feeding: We propose a pilot and feasibility trial of a 10 hour time restricted eating intervention among post-bariatric surgery patients.
|
|---|---|
|
Systolic Blood Pressure
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5.4 mmHg
Standard Deviation 14.75
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SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: Six participants started the intervention, and we analyzed data from 5 participant who provided blood pressure measurements before and after the intervention
Compare changes from baseline to the end of the 12-week intervention in diastolic blood pressure.
Outcome measures
| Measure |
Intervention
n=5 Participants
To test the effects of a 10-hour time restricted eating intervention before and after the 12 weeks of treatment on weight (primary), caloric and macronutrient intake, and a variety of psychosocial measures, including sleep, physical activity, blood pressure and eating behaviors (all secondary).
Time restricted feeding: We propose a pilot and feasibility trial of a 10 hour time restricted eating intervention among post-bariatric surgery patients.
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|---|---|
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Diastolic Blood Pressure
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-1.8 mmHg
Standard Deviation 6.34
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Adverse Events
Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kelly C. Allison, PhD
Perelman School of Medicine at the University of Pennsylvania
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place