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Completed

NCT Number: NCT03036696

The BEACH Interview Study- Pregnant and Breastfeeding Mothers

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

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Key information

Conditions

Pediatric Obesity Behavior Body Weight Breast Feeding Feeding Behavior Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Recruitment Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Magda Francois

Gainesville, Florida, 32608, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Pregnant Mothers Interview

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

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.

Primary outcomes

  1. Strategies for recruiting and retaining pregnant and breastfeeding mothers into clinical research studies (CRTs) will be measured by way of interview.

    Time frame: 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.

Secondary outcomes

  1. Measure bioactive compounds in human milk (HM) via Enzyme-linked immunosorbent assay (ELISA)

    Time frame: 1 year

  2. Quantify the infant intestinal gene expression profile in stool by real-time polymerase chain reaction (PCR)

    Time frame: 1 year

  3. Measure the infant intestinal gene expression profile in stool via whole genome sequencing (WGS)

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

The Breastfeeding and Early Child Health (BEACH) Interview Study

Acronym: BEACH

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 30, 2017
Registry last updated
Aug 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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