NCT04494971

Brief Summary

The objective is to examine the preliminary validity, reliability and perceived participant satisfaction of the PortionSize app.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

August 31, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2020

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

October 15, 2024

Completed
Last Updated

November 19, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

July 28, 2020

Results QC Date

May 10, 2024

Last Update Submit

October 31, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Validity of Portion Size at Estimating Energy Intake in Laboratory Conditions

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

    1 simulated meal collected on one day

  • Validity of Portion Size at Estimating Energy Intake in Free-living Conditions

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

    Mean kcal intake over 3 days

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy participants ages 18 to 65 in the Baton Rouge, LA area.

You may qualify if:

  • BMI 18.5-45 kg/m2 based upon self-reported height and weight
  • Have an iPhone and an operable Apple ID, password, and email address and is willing to use these to collect data during the study, acknowledging that data usage, and associated charges, are a result of study participation

You may not qualify if:

  • For females, pregnancy or breast feeding
  • Currently diagnosed with an eating disorder
  • Disease that severely affects metabolism, including diabetes, hypercholesterolemia, or dyslipidemia
  • Has gained or lost more than 10 lbs in the last 3 months
  • PBRC faculty/staff member
  • Has suffered serious mental illness that has resulted in serious functional impairment and has substantially interfered with one's life activities within the last 5 years
  • Any other medical, psychiatric, or behavioral factors in the judgment of the Principle Investigator that may interfere with study participation or the ability to follow the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

  • Diktas HE, Lozano CP, Saha S, Broyles ST, Martin CK, Apolzan JW. Evaluating the Validity of the PortionSize Smartphone Application for Estimating Dietary Intake in Free-Living Conditions: A Pilot Study. J Nutr Educ Behav. 2024 Sep;56(9):643-652. doi: 10.1016/j.jneb.2024.05.226. Epub 2024 Jun 18.

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Results Point of Contact

Title
Dr. Hanim Ecem Diktas
Organization
Pennington Biomedical Research Center

Study Officials

  • John Apolzan, PhD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR
  • James Dorling, PhD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR
  • Corby Martin, PhD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PBRC Professor, Director - Ingestive Behavior Laboratory

Study Record Dates

First Submitted

July 28, 2020

First Posted

July 31, 2020

Study Start

August 31, 2020

Primary Completion

November 20, 2020

Study Completion

November 20, 2020

Last Updated

November 19, 2024

Results First Posted

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations