Clinical trial NCT03033459: Prenatal Lactation-Focused Motivational Interviewing
Official title: Enhancing Breastfeeding Initiation, Exclusivity, and Duration: Effects of Prenatal Lactation-Focused Motivational Interviewing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Feeding
Lactation Puerperal Increased
Infant Behavior
Maternal Behavior
Keywords: breast feeding
motivational interviewing
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Breastfeeding status at 1 month postpartum, participant self-report via telephone interview
timeFrame: 1 month
Secondary outcomes:
measure: Confidence (scale of 0-10)
timeFrame: 1 day
measure: Importance (scale of 0-10)
timeFrame: 1 day
measure: Knowledge of breastfeeding-Breastfeeding Knowledge Questionnaire (survey)
timeFrame: 1 day
measure: Attitudes towards breastfeeding- Iowa Infant Feeding Attitudes Scale (survey)
timeFrame: 1 day
measure: Knowledge of infant development- Knowledge of Infant Development Inventory (survey)
timeFrame: 1 day
measure: Intention to breastfeed Self-reported intention to breastfeed at prenatal time point
timeFrame: 1 day
measure: Initiation Whether participant initiated breastfeeding, participant self-report via telephone interview
timeFrame: 1 month
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Daniel W McNeil, PHD
role: PRINCIPAL_INVESTIGATOR
References: