NCT05906160

Brief Summary

The objective is to test the accuracy of the PortionSize™ app and the MyFitnessPal© app at measuring energy intake in free-living conditions, tested against the gold-standard, doubly labeled water. Participants will use PortionSize™ and MyFitnessPal apps in separate periods to test the accuracy of the respective apps.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Typical duration 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

May 26, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

June 22, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2024

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

May 26, 2023

Last Update Submit

April 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Energy Intake (kcal)

    Test the equivalence between PortionSize (and MyFitnessPal) and the criterion measure, which is energy intake assessed with DLW. These analyses will rely on equivalence testing using the Two One-side T-test (TOST) method, as well as Bland and Altman analyses.

    May 2023 through February 2025

Eligibility Criteria

Age18 Years - 62 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Adults aged 18-62, males and females.

You may qualify if:

  • Male or female, age 18-62 years
  • Body mass index (BMI) 18.5-50 kg/m2
  • Ownership of an iPhone model 9 or later, which the participant is willing to use for the study
  • Access to Apple ID, password, and email address and willing to use them during the study
  • Willing to use data and any accompanying charges as part of study participation
  • Willing to complete all study procedures and adhere to study visit timelines
  • Willing to be re-contacted for future research and/or follow-up

You may not qualify if:

  • oHave been 6-month weight unstable (gain/loss \>5% last 6 months) and/or active weight loss program
  • Any cardiometabolic disorder that significantly affects what or how much people eat
  • Active cancer diagnosis or treatment that significantly affects what or how much people eat, excluding some melanomas and other cancers
  • PBRC employee, as previous reviewers argued that they are not representative of the community (
  • rd member of the same household to participate (i.e. the 1st and 2nd members of the household cannot participate simultaneously)
  • Women who are currently pregnant or breastfeeding (self-reported)
  • Diagnosed with an uncontrolled thyroid disorder (controlled ≥ 3 months of medication)
  • Have had or plan to have weight loss surgery (gastric band removal may be allowed at PI discretion)
  • Consume \>28 alcoholic beverages per week
  • Anyone severely immunocompromised
  • Serious digestive disorders that significantly affect what or how much people eat Fluid imbalance and/or on diuretic
  • Follows a diet mainly consisting of foods that study staff deems unquantifiable for this study (i.e., liquid supplements, gluten-free specialty items) or consumes a high quantity of specialty foods
  • Any condition or circumstance that, in the judgement of the PIs, couldimpede study completion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

The study relies on urine samples, which contain a small amount of DNA that degrades after about 4 weeks. The study will not obtain or analyze any DNA related data. The urine will be analyzed to quantify energy expenditure and by extension energy intake.

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • John W Apolzan, Ph.D.

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 26, 2023

First Posted

June 15, 2023

Study Start

June 22, 2023

Primary Completion

November 25, 2024

Study Completion

March 31, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Locations