Participation of Breast Milk Feeding Mothers in Research | NCT03072251

Studies
Participation of Breast Milk Feeding Mothers in Research

NCT03072251

Sponsor

Pennington Biomedical Research Center

Status

Completed

Last Update Posted

Sep 27, 2022Actual

Enrollment

570Actual

Phase

Not provided

Conditions

Breastfeeding
Energy Intake
eHealth

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 5, 2017Actual

Primary Completion Date

Oct 22, 2018Actual

Completion Date

Oct 22, 2018Actual

First Submitted Date

Feb 24, 2017

First Submission Date that Met QC Criteria

Mar 1, 2017

First Posted Date

Mar 7, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2022

Last Update Posted Date

Sep 27, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Leanne Redman, Principal Investigator, Pennington Biomedical Research CenterPrincipal Investigator

Lead Sponsor

Pennington Biomedical Research CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

570Actual

Label	Type	Description	Intervention Names
Anyone		Any individual may complete this survey

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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 Outcomes

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)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any individual may take the survey.

Exclusion Criteria:

None

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leanne Redman, Ph.D.	Pennington Biomedical Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pennington Biomedical Research Center		Baton Rouge	Louisiana	70808	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001942	Breast Feeding

Ancestor Terms

ID	Term
D005247	Feeding Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided