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

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

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 day

Compared measurements from PortionSize to weighed values in the laboratory, which is the criterion measure.

Outcome measures

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 days

Quantify the validity of the app measurements in free-living conditions compared to digital photography (the criterion measure).

Outcome measures

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

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place