Prenatal Lactation-Focused Motivational Interviewing



Status:Recruiting
Healthy:No
Age Range:18 - 99
Updated:1/27/2017
Start Date:September 2016
End Date:September 2017
Contact:Daniel W. McNeil, PhD
Email:dmcneil@wvu.edu
Phone:3042931708

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

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.

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 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.

Inclusion Criteria:

1. Age 18 years or older

2. Female

3. Pregnant

4. At least 27 weeks pregnant

5. Able to read, write, speak, and understand English

6. Has access to a phone (either mobile or landline)

7. Lives within driving distance of Morgantown, WV, or is willing to travel to a
location that is within driving distance to Morgantown, WV

Exclusion Criteria:

1. Multiple pregnancy

2. Within one week of due date

3. Has any of the following conditions:

- Developmental or intellectual disability

- Schizophrenia

- Untreated, active tuberculosis

- Human immunodeficiency virus (HIV)/Acquired immunodeficiency syndrome (AIDS)

- Human T-cell lymphotropic virus type I or type II

- History of lumpectomy or radiation to breast

4. Uses or is dependent upon any of the following substances (Moretti, Lee, & Ito,
2000):

- Heroin

- Cocaine

- Methamphetamines

- Marijuana

- Phencyclidine (PCP)

- Non-prescription opioids (e.g., morphine, oxycodone, hydrocodone)

5. Undergoing any of the following medications/treatments (American Academy of
Pediatrics, 2001):

- Antiretrovirals

- Cancer chemotherapy (e.g., antimetabolites)

- Radiation therapy

- Acebutolol

- Atenolol

- Bromocriptine

- Aspirin (salicylates)

- Ergotamine

- Lithium

- Phenobarbital

- Primidone

- Sulfasalazine (salicylazosulfapyridine)
We found this trial at
1
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Morgantown, West Virginia 26506
(304) 293-0111
Phone: 304-193-1712
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