Participation of Breast Milk Feeding Mothers in Research

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.

Study Overview

• Status: Completed
• Conditions: eHealth; Breastfeeding; Energy Intake

Detailed Description

Study participation will be the completion of an anonymous, online survey powered by HIPAA compliant REDCap database. The survey will be made available to potential participants through the internet. The survey will take approximately five minutes to complete. The expected duration of recruitment and completion of the study is six months.

• Study Type: Observational
• Enrollment (Actual): 570

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Any individual may take the survey.

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Anyone; Any individual may complete this survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Receptivity for measuring milk intake for 5-7 days using a smartphone app	Outcome measured by questionnaire	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Receptivity for expressing human breast milk to assess milk intake for 5-7 days	Outcome measured by questionnaire	1 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of breastfeeding in the survey population (exclusive, in combination with infant formula, in combination with other foods)	Outcome measured by questionnaire	1 day
Method of feeding (breast, expressed human milk in an infant feeding bottle, combination of feeding methods)	Outcome measured by questionnaire	1 day

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Investigators: Principal Investigator: Leanne Redman, Ph.D., Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2017
• Primary Completion (Actual): October 22, 2018
• Study Completion (Actual): October 22, 2018

Study Registration Dates

• First Submitted: February 24, 2017
• First Submitted That Met QC Criteria: March 1, 2017
• First Posted (Actual): March 7, 2017

Study Record Updates

• Last Update Posted (Actual): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: PBRC 2017-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No