The BEACH Interview Study- Pregnant and Breastfeeding Mothers (BEACH)
The Breastfeeding and Early Child Health (BEACH) Interview Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Florida
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Gainesville, Florida, États-Unis, 32608
- Magda Francois
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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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.
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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.
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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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Strategies for recruiting and retaining pregnant and breastfeeding mothers into clinical research studies (CRTs) will be measured by way of interview.
Délai: 6 months
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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.
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6 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Mesurer les composés bioactifs dans le lait maternel (HM) via un dosage immuno-enzymatique (ELISA)
Délai: 1 an
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1 an
|
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Quantifier le profil d'expression des gènes intestinaux du nourrisson dans les selles par réaction en chaîne par polymérase (PCR) en temps réel
Délai: 1 an
|
1 an
|
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Measure the infant intestinal gene expression profile in stool via whole genome sequencing (WGS)
Délai: 1 year
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1 year
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB201601909
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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