Trial Outcomes & Findings for The PortionSize Smartphone App Pilot (PS Pilot) (NCT NCT04494971)
NCT ID: NCT04494971
Last Updated: 2024-11-19
Results Overview
Compared measurements from PortionSize to weighed values in the laboratory, which is the criterion measure.
Recruitment status
COMPLETED
Target enrollment
15 participants
Primary outcome timeframe
1 simulated meal collected on one day
Results posted on
2024-11-19
Participant Flow
Participant milestones
| Measure |
Study Cohort
The validity, reliability, and satisfaction of the PortionSize app under controlled and free-living conditions were quantified.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The PortionSize Smartphone App Pilot (PS Pilot)
Baseline characteristics by cohort
| Measure |
Study Cohort
n=15 Participants
The validity, reliability, and satisfaction of the PortionSize app under controlled and free-living conditions were quantified.
|
|---|---|
|
Age, Categorical
<=18 years
|
NA Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
NA Participants
n=5 Participants
|
|
Age, Continuous
|
28 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 simulated meal collected on one dayCompared measurements from PortionSize to weighed values in the laboratory, which is the criterion measure.
Outcome measures
| Measure |
Study Cohort
n=15 Participants
The validity of the PortionSize app under controlled (laboratory) conditions was quantified.
|
|---|---|
|
Validity of Portion Size at Estimating Energy Intake in Laboratory Conditions
Mean energy intake estimated with the PortionSize app
|
742.9 kcal
Standard Deviation 328
|
|
Validity of Portion Size at Estimating Energy Intake in Laboratory Conditions
Mean energy intake estimated with the directly weighed food portions
|
659.3 kcal
Standard Deviation 190.7
|
PRIMARY outcome
Timeframe: Mean kcal intake over 3 daysQuantify the validity of the app measurements in free-living conditions compared to digital photography (the criterion measure).
Outcome measures
| Measure |
Study Cohort
n=14 Participants
The validity of the PortionSize app under controlled (laboratory) conditions was quantified.
|
|---|---|
|
Validity of Portion Size at Estimating Energy Intake in Free-living Conditions
Mean energy intake estimated with the PortionSize app
|
1560.6 kcal
Standard Deviation 446.8
|
|
Validity of Portion Size at Estimating Energy Intake in Free-living Conditions
Mean energy intake estimated with rater analysis of food photos
|
1349.7 kcal
Standard Deviation 389.2
|
Adverse Events
Study Cohort
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
Dr. Hanim Ecem Diktas
Pennington Biomedical Research Center
Phone: (225) 763-2832
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place