Clinical Trial: Prenatal Lactation-Focused Motivational Interviewing

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Enhancing Breastfeeding Initiation, Exclusivity, and Duration: Effects of Prenatal Lactation-Focused Motivational Interviewing

Brief Summary: Breastfeeding is good for the health of both mother and baby, but many women do not breastfeed, or do not breastfeed for as long as they would like. The purpose of this study is to compare two types of interventions on how they impact breastfeeding. The interventions will be given during the third trimester of pregnancy, and the intervention is individual (i.e., one therapist and one participant). The first intervention is Motivational Interviewing, a type of counseling. The second intervention, or "control group," is education on how babies grow and develop. There general aims of this study are to compare women in the Motivational Interviewing group and control group on how they plan to feed their babies, how much they learn about and their opinions about breastfeeding, and how much they learn about how babies grow and develop. In addition, the groups will be compared as to whether they start breastfeeding, and how they are feeding their baby when the baby is one month old.

Detailed Summary:

  1. Recruitment efforts will be made in the community via advertisements, online advertisements (e.g., Craigslist, Facebook), and in-person at various clinics and health fairs in the geographic area.
  2. Prospective participants will contact the investigators via email or by calling the study phone number listed on the advertisements or verbally expressing interest in-person.
  3. Once a participant indicates interest by contacting study personnel, a 5-minute screening interview will be conducted with the prospective participant using the screening questionnaire to ensure eligibility criteria are met. For those who do not qualify or agree to participate, the age and reason for non-qualification or declination to participate will be recorded; any other data will be destroyed by shredding or electronic shredding. For those who do qualify, name and contact information will be kept confidential and maintained in a locked room.
  4. Participants will be asked to rate on a scale of -10 to +10 about their certainty that they will provide exclusive breastmilk to their babies for first six months. Responses from this item will be used as the covariate in the covariate adaptive randomization technique.
  5. Eligible subjects will be invited to participate in the study, either in an exam room at West Virginia University's Family Medicine's clinic, participant's home, private room in the Quin Curtis Center for Psychological Services, or in another agreed-upon community location (e.g., church). The location of the study procedures is chosen by the participant.
  6. At the start of this session, participants will be given an overview of the study, and the researcher will go over the consent form with them.
  7. Following consent
    Sponsor: West Virginia University

    Current Primary Outcome: Breastfeeding status at 1 month postpartum, participant self-report via telephone interview [ Time Frame: 1 month ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Confidence (scale of 0-10) [ Time Frame: 1 day ]
      Participant self-report of confidence in breastfeeding, scale of 0-10
    • Importance (scale of 0-10) [ Time Frame: 1 day ]
      Participant self-report of importance of breastfeeding, scale of 0-10
    • Knowledge of breastfeeding-Breastfeeding Knowledge Questionnaire (survey) [ Time Frame: 1 day ]
    • Attitudes towards breastfeeding- Iowa Infant Feeding Attitudes Scale (survey) [ Time Frame: 1 day ]
    • Knowledge of infant development- Knowledge of Infant Development Inventory (survey) [ Time Frame: 1 day ]
    • Intention to breastfeed Self-reported intention to breastfeed at prenatal time point [ Time Frame: 1 day ]
    • Initiation Whether participant initiated breastfeeding, participant self-report via telephone interview [ Time Frame: 1 month ]


    Original Secondary Outcome: Same as current

    Information By: West Virginia University

    Dates:
    Date Received: January 18, 2017
    Date Started: September 2016
    Date Completion: September 2017
    Last Updated: January 25, 2017
    Last Verified: January 2017