Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03033459 |
Other study ID # |
1605123038 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 2016 |
Est. completion date |
June 7, 2019 |
Study information
Verified date |
October 2022 |
Source |
West Virginia University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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 the participant would like. The purpose of
this study is to compare two types of interventions on how each impacts 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 the participants plan to feed the
babies, how much the participants learn about and the participants opinions about
breastfeeding, and how much the participants learn about how babies grow and develop. In
addition, the groups will be compared as to whether the participants start breastfeeding, and
how the participants are feeding the baby when the baby is one month old.
Description:
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 the certainty that the
participants will provide exclusive breastmilk to the 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 the participant.
7. Following consent procedures, video-recording will begin, and all participants will
complete the prenatal interview. After this interview, participants will complete five
self-report measures, which include the Infant Feeding Knowledge Form, the Iowa Infant
Feeding Attitudes Scale, Brief Breastfeeding Attitudes Questions, Perinatal Anxiety
Screening Scale, and the Knowledge of Infant Development Inventory.
8. Intervention
1. Participants assigned to the MI condition will receive an approximately 45 minute
intervention provided a masters-level supervised psychologist with training in
Motivational Interviewing.
2. Participants who have been randomly assigned to participate in the
attention-control group session will receive approximately 45 minutes of
psychoeducation on typical developmental stages and infant feeding methods.