Prenatal Lactation-Focused Motivational Interviewing

Sponsor
West Virginia University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03033459
Collaborator
(none)
80
1
2
12
6.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Motivational Interviewing
  • Behavioral: Psychoeducation Control
N/A

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 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

  9. Participants assigned to the MI condition will receive an approximately 45 minute intervention provided a masters-level supervised psychologist with training in Motivational Interviewing.

  10. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Enhancing Breastfeeding Initiation, Exclusivity, and Duration: Effects of Prenatal Lactation-Focused Motivational Interviewing
Study Start Date :
Sep 1, 2016
Anticipated Primary Completion Date :
Sep 1, 2017
Anticipated Study Completion Date :
Sep 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Motivational Interviewing

Participants assigned to the Motivational Interviewing condition will receive an approximately 45 (± 5) minute intervention provided by a female masters-level supervised psychologist with training in Motivational Interviewing.

Behavioral: Motivational Interviewing
Motivational Interviewing (MI) is a psychosocial intervention designed to help individuals increase readiness for behavior change by increasing intrinsic motivation and resolving ambivalence. MI founders MI conversations help clients change behavior through identifying and resolving discrepancies between goal behaviors and actual behaviors. Behavior change is promoted through the elicitation of "change talk," or client-verbalized arguments for change. In MI, change talk is elicited through two major components: the therapeutic relationship, or the embodiment of the "spirit" of MI, and technical skill.

Active Comparator: Psychoeducation Control

Participants who have been randomly assigned to participate in the attention-control group session will receive approximately 45 (± 5) minutes of psychoeducation on typical developmental stages and infant feeding methods. The psychoeducation will be provided by a female masters-level supervised psychologist.

Behavioral: Psychoeducation Control
Psychoeducation on infant development, age 0-15 months, brief education on breastfeeding.

Outcome Measures

Primary Outcome Measures

  1. Breastfeeding status at 1 month postpartum, participant self-report via telephone interview [1 month]

Secondary Outcome Measures

  1. Confidence (scale of 0-10) [1 day]

    Participant self-report of confidence in breastfeeding, scale of 0-10

  2. Importance (scale of 0-10) [1 day]

    Participant self-report of importance of breastfeeding, scale of 0-10

  3. Knowledge of breastfeeding-Breastfeeding Knowledge Questionnaire (survey) [1 day]

  4. Attitudes towards breastfeeding- Iowa Infant Feeding Attitudes Scale (survey) [1 day]

  5. Knowledge of infant development- Knowledge of Infant Development Inventory (survey) [1 day]

  6. Intention to breastfeed Self-reported intention to breastfeed at prenatal time point [1 day]

  7. Initiation Whether participant initiated breastfeeding, participant self-report via telephone interview [1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

  1. 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)

  1. 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 West Virginia University Morgantown West Virginia United States 26505

Sponsors and Collaborators

  • West Virginia University

Investigators

  • Principal Investigator: Daniel W McNeil, PHD, West Virginia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Daniel W. McNeil, PhD, Professor, West Virginia University
ClinicalTrials.gov Identifier:
NCT03033459
Other Study ID Numbers:
  • 1605123038
First Posted:
Jan 26, 2017
Last Update Posted:
Jan 26, 2017
Last Verified:
Jan 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Daniel W. McNeil, PhD, Professor, West Virginia University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 26, 2017