The BEACH Interview Study- Pregnant and Breastfeeding Mothers

NCT ID: NCT03036696

Last Updated: 2019-08-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 59 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-07
• Study Completion Date: 2019-08-09

Brief Summary

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

Detailed Description

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.

Conditions

Pediatric Obesity; Recruitment

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Pregnant Mothers Interview

Intervention Type: OTHER

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.

Breastfeeding Mothers Interview

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dominick J Lemas, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Magda Francois

Gainesville, Florida, United States

Countries

United States

Other Identifiers

IRB201601909

Identifier Type: -

Identifier Source: org_study_id