NCT03072251

Brief Summary

To assess concerns and barriers for measuring milk intake of breast fed infants using the remote food photography method and SmartIntake smartphone application. These data will 1) provide support for further development of the Infant RFPM and 2) provide important preliminary data in a National Institutes of Health grant application being developed and assess the prevalence of exclusive breastfeeding and complementary breastfeeding in the study population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
570

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

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

Study Start

First participant enrolled

February 5, 2017

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2018

Completed
Last Updated

September 27, 2022

Status Verified

September 1, 2022

Enrollment Period

1.7 years

First QC Date

February 24, 2017

Last Update Submit

September 26, 2022

Conditions

BreastfeedingEnergy IntakeeHealth

Outcome Measures

Primary Outcomes (1)

  • Receptivity for measuring milk intake for 5-7 days using a smartphone app

    Outcome measured by questionnaire

    1 day

Secondary Outcomes (1)

  • Receptivity for expressing human breast milk to assess milk intake for 5-7 days

    1 day

Other Outcomes (2)

  • Prevalence of breastfeeding in the survey population (exclusive, in combination with infant formula, in combination with other foods)

    1 day

  • Method of feeding (breast, expressed human milk in an infant feeding bottle, combination of feeding methods)

    1 day

Study Arms (1)

Anyone

Any individual may complete this survey

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects will be recruited from the community via print, electronic, and social media. Any individual may take the survey.

You may qualify if:

  • Any individual may take the survey.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Leanne Redman, Ph.D.

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 24, 2017

First Posted

March 7, 2017

Study Start

February 5, 2017

Primary Completion

October 22, 2018

Study Completion

October 22, 2018

Last Updated

September 27, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)