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The BEACH Interview Study- Pregnant and Breastfeeding Mothers (BEACH)

9. august 2019 opdateret af: University of Florida

The Breastfeeding and Early Child Health (BEACH) Interview Study

Interview pregnant and breastfeeding mothers in the Gainesville, FL area to optimize; clinical study recruitment and retention, patient-centered outcomes, and stool collection procedures.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is an interview study that will enroll mothers during 28 weeks or greater of pregnancy and assess recruitment, patient-centered outcomes, and stool collection procedures via individualized interviews and data collection. Participants will be recruited from the greater Gainesville, FL area. Data collection will include questionnaires/surveys as well as minimal risk non-invasive biological samples such as stool, human milk, saliva, vaginal swab, and urine collection. Participants will be seen at a location convenient for them.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

59

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Florida
      • Gainesville, Florida, Forenede Stater, 32608
        • Magda Francois

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 45 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The research team will recruit pregnant women (n = 30) and breastfeeding mothers' (n = 30) paired with infant (n=30) to participate in individual, in-depth, semi structured, and audio-recorded interviews.

Beskrivelse

Inclusion Criteria:

  • Females 18>45, between 28-38 weeks pregnant, lives in Gainesville, Florida, and committed to exclusively breastfeeding through 6 months.
  • Females 18>45, actively breastfeeding for <12 months and lives in Gainesville, Florida

Exclusion Criteria:

  • Mothers who do not plan to exclusively breastfeed their infant for at least the first 6 months or actively breastfeeding.
  • Mothers who do not live in Gainesville, FL
  • Mothers who are not between the ages of 18-45
  • Mothers who are not between 28-38 weeks of gestation or a breastfeeding mother.
  • Mothers who have only one breast which is capable of producing milk and/or have a history of inadequate milk production.
  • Mothers who have consumed alcohol during this pregnancy.
  • Mothers who have abused drugs during this pregnancy.
  • Mothers who have smoked during this pregnancy.
  • Mothers who have been diagnosed with pre-eclampsia during this pregnancy.
  • Mothers who have had a previous pre-term delivery (baby born 2 months before the due date or <35 weeks).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Pregnant Mothers Interview
(1) 18 years old or over, (2) between 28-38 weeks of pregnancy, (3) lives in Gainesville, Florida, and (4) are committed to exclusively breastfeeding through 6 months.
Andet: Pregnant Mothers Interview

Pregnant mothers will be interviewed and asked to provide feedback on common strategies used for recruitment, challenges that would preclude them from enrolling and participating in CRTs, their preferences for incentives, data collection, bio-specimen collection and preferences for methods related to non-invasive sample collection.

Data collection for pregnant mothers includes Clinical Health Update (3rd trimester) and Physical Activity questionnaires.

The following will be collected from mothers during the interview: self-reported behavioral data, maternal human milk (HM), stool, urine, saliva, and vaginal swab.
Breastfeeding Mothers Interview
(1) 18 years old or over, (2) actively breastfeeding infant less than 12 months of age, and (3) lives in Gainesville, Florida.
Andet: Breastfeeding Mothers Interview

Breastfeeding mothers will be interviewed and asked to provide feedback on common strategies used for recruitment, challenges that would preclude them from enrolling and participating in CRTs, their preferences for incentives, data collection, bio-specimen collection, and preferences for methods related to non-invasive sample collection.

Data collection for breastfeeding mothers includes Clinical Health update (post-natal), Infant Feeding, and Physical Activity questionnaires.

The following will be collected from mothers during the interview: self-reported behavioral data, maternal human milk (HM), stool, urine, saliva, and vaginal swab.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Strategies for recruiting and retaining pregnant and breastfeeding mothers into clinical research studies (CRTs) will be measured by way of interview.
Tidsramme: 6 months
Interviews will be analyzed to determine the efficacy of common strategies used to recruit pregnant and breastfeeding mothers into CRTs, challenges or barriers that would preclude women from enrolling and participating in CRTs, their preferences for incentives, as well their preference and methods related to non-invasive sample collection.
6 months

Sekundære resultatmål

Resultatmål
Tidsramme
Mål bioaktive forbindelser i human mælk (HM) via Enzyme-linked immunosorbent assay (ELISA)
Tidsramme: 1 år
1 år
Kvantificer spædbarnets intestinale genekspressionsprofil i afføring ved real-time polymerase chain reaction (PCR)
Tidsramme: 1 år
1 år
Measure the infant intestinal gene expression profile in stool via whole genome sequencing (WGS)
Tidsramme: 1 year
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Florida

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. september 2017

Primær færdiggørelse (Faktiske)

9. august 2019

Studieafslutning (Faktiske)

9. august 2019

Datoer for studieregistrering

Først indsendt

27. januar 2017

Først indsendt, der opfyldte QC-kriterier

27. januar 2017

Først opslået (Skøn)

30. januar 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. august 2019

Sidst verificeret

1. august 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB201601909

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

In accordance with the NIH Data Sharing Policy of award 1U24DK097193, all data generated by Southeast Center for Integrated Metabolomics (SECIM), along with the corresponding metadata, will be deposited into the NIH Metabolomics Data Repository and Coordinating Center (DRCC) as soon as all quality control steps are completed. Data will be embargoed for one year and, after the expiration of the embargo, made visible to the scientific community regardless of publication status for the data.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Pædiatrisk fedme

Kliniske forsøg med Pregnant Mothers Interview

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Venezuela

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner